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Review
. 2022 May 3;5(5):CD004523.
doi: 10.1002/14651858.CD004523.pub4.

Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women

Affiliations
Review

Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women

George A Wells et al. Cochrane Database Syst Rev. .

Abstract

Background: Osteoporosis is an abnormal reduction in bone mass and bone deterioration leading to increased fracture risk. Risedronate belongs to the bisphosphonate class of drugs which act to inhibit bone resorption by interfering with the activity of osteoclasts. This is an update of a Cochrane Review that was originally published in 2003.

Objectives: We assessed the benefits and harms of risedronate in the primary and secondary prevention of osteoporotic fractures for postmenopausal women at lower and higher risk for fractures, respectively.

Search methods: With broader and updated strategies, we searched the Cochrane Central Register of Control Trials (CENTRAL), MEDLINE and Embase. A grey literature search, including the online databases ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP), and drug approval agencies, as well as bibliography checks of relevant systematic reviews was also performed. Eligible trials published between 1966 to 24 March 2021 were identified.

Selection criteria: We included randomised controlled trials that assessed the benefits and harms of risedronate in the prevention of fractures for postmenopausal women. Participants must have received at least one year of risedronate, placebo or other anti-osteoporotic drugs, with or without concurrent calcium/vitamin D. Major outcomes were clinical vertebral, non-vertebral, hip and wrist fractures, withdrawals due to adverse events, and serious adverse events. In the interest of clinical relevance and applicability, we classified a study as secondary prevention if its population fulfilled more than one of the following hierarchical criteria: a diagnosis of osteoporosis, a history of vertebral fractures, low bone mineral density (BMD)T score ≤ -2.5, and age ≥ 75 years old. If none of these criteria was met, the study was considered to be primary prevention.

Data collection and analysis: We used standard methodology expected by Cochrane. We pooled the relative risk (RR) of fractures using a fixed-effect model based on the expectation that the clinical and methodological characteristics of the respective primary and secondary prevention studies would be homogeneous, and the experience from the previous review suggesting that there would be a small number of studies. The base case included the data available for the longest treatment period in each placebo-controlled trial and a >15% relative change was considered clinically important. The main findings of the review were presented in summary of findings tables, using the GRADE approach. In addition, we looked at benefit and harm comparisons between different dosage regimens for risedronate and between risedronate and other anti-osteoporotic drugs.

Main results: Forty-three trials fulfilled the eligibility criteria, among which 33 studies (27,348 participants) reported data that could be extracted and quantitatively synthesized. We had concerns about particular domains of risk of bias in each trial. Selection bias was the most frequent concern, with only 24% of the studies describing appropriate methods for both sequence generation and allocation concealment. Fifty per cent and 39% of the studies reporting benefit and harm outcomes, respectively, were subject to high risk. None of the studies included in the quantitative syntheses were judged to be at low risk of bias in all seven domains. The results described below pertain to the comparisons for daily risedronate 5 mg versus placebo which reported major outcomes. Other comparisons are described in the full text. For primary prevention, low- to very low-certainty evidence was collected from four studies (one to two years in length) including 989 postmenopausal women at lower risk of fractures. Risedronate 5 mg/day may make little or no difference to wrist fractures [RR 0.48 ( 95% CI 0.03 to 7.50; two studies, 243 participants); absolute risk reduction (ARR) 0.6% fewer (95% CI 1% fewer to 7% more)] and withdrawals due to adverse events [RR 0.67 (95% CI 0.38 to 1.18; three studies, 748 participants); ARR 2% fewer (95% CI 5% fewer to 1% more)], based on low-certainty evidence. However, its preventive effects on non-vertebral fractures and serious adverse events are not known due to the very low-certainty evidence. There were zero clinical vertebral and hip fractures reported therefore the effects of risedronate for these outcomes are not estimable. For secondary prevention, nine studies (one to three years in length) including 14,354 postmenopausal women at higher risk of fractures provided evidence. Risedronate 5 mg/day probably prevents non-vertebral fractures [RR 0.80 (95% CI 0.72 to 0.90; six studies, 12,173 participants); RRR 20% (95% CI 10% to 28%) and ARR 2% fewer (95% CI 1% fewer to 3% fewer), moderate certainty], and may reduce hip fractures [RR 0.73 (95% CI 0.56 to 0.94); RRR 27% (95% CI 6% to 44%) and ARR 1% fewer (95% CI 0.2% fewer to 1% fewer), low certainty]. Both of these effects are probably clinically important. However, risedronate's effects are not known for wrist fractures [RR 0.64 (95% CI 0.33 to 1.24); three studies,1746 participants); ARR 1% fewer (95% CI 2% fewer to 1% more), very-low certainty] and not estimable for clinical vertebral fractures due to zero events reported (low certainty). Risedronate results in little to no difference in withdrawals due to adverse events [RR 0.98 (95% CI 0.90 to 1.07; eight studies, 9529 participants); ARR 0.3% fewer (95% CI 2% fewer to 1% more); 16.9% in risedronate versus 17.2% in control, high certainty] and probably results in little to no difference in serious adverse events [RR 1.00 (95% CI 0.94 to 1.07; six studies, 9435 participants); ARR 0% fewer (95% CI 2% fewer to 2% more; 29.2% in both groups, moderate certainty).

Authors' conclusions: This update recaps the key findings from our previous review that, for secondary prevention, risedronate 5 mg/day probably prevents non-vertebral fracture, and may reduce the risk of hip fractures. We are uncertain on whether risedronate 5mg/day reduces clinical vertebral and wrist fractures. Compared to placebo, risedronate probably does not increase the risk of serious adverse events. For primary prevention, the benefit and harms of risedronate were supported by limited evidence with high uncertainty.

PubMed Disclaimer

Conflict of interest statement

None at present.

This current review was updated without the support of any industry sponsor.

Figures

1
1
Hierarchical Classification Algorithm for Primary and Secondary Prevention Trials
2
2
PRISMA Diagram * In the literature update search conducted on 24 March 2021, eight new studies (one reporting and seven not reporting outcome data) and one companion article were identified.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
1.1
1.1. Analysis
Comparison 1: Risedronate 5 mg/day vs Placebo ‐ Base case, Outcome 1: Clinical vertebral fractures
1.2
1.2. Analysis
Comparison 1: Risedronate 5 mg/day vs Placebo ‐ Base case, Outcome 2: Non‐vertebral fractures
1.3
1.3. Analysis
Comparison 1: Risedronate 5 mg/day vs Placebo ‐ Base case, Outcome 3: Hip fractures
1.4
1.4. Analysis
Comparison 1: Risedronate 5 mg/day vs Placebo ‐ Base case, Outcome 4: Wrist fractures
1.5
1.5. Analysis
Comparison 1: Risedronate 5 mg/day vs Placebo ‐ Base case, Outcome 5: Radiographic vertebral fractures
1.6
1.6. Analysis
Comparison 1: Risedronate 5 mg/day vs Placebo ‐ Base case, Outcome 6: Withdrawals due to adverse events
1.7
1.7. Analysis
Comparison 1: Risedronate 5 mg/day vs Placebo ‐ Base case, Outcome 7: Serious adverse events
1.8
1.8. Analysis
Comparison 1: Risedronate 5 mg/day vs Placebo ‐ Base case, Outcome 8: Gastrointestinal adverse events
1.9
1.9. Analysis
Comparison 1: Risedronate 5 mg/day vs Placebo ‐ Base case, Outcome 9: Atypical femoral fracture
2.1
2.1. Analysis
Comparison 2: Risedronate 5 mg/day vs Placebo ‐ Subgroup of 1‐year studies, Outcome 1: Clinical vertebral fractures
2.2
2.2. Analysis
Comparison 2: Risedronate 5 mg/day vs Placebo ‐ Subgroup of 1‐year studies, Outcome 2: Non‐vertebral Fractures
2.3
2.3. Analysis
Comparison 2: Risedronate 5 mg/day vs Placebo ‐ Subgroup of 1‐year studies, Outcome 3: Hip Fractures
2.4
2.4. Analysis
Comparison 2: Risedronate 5 mg/day vs Placebo ‐ Subgroup of 1‐year studies, Outcome 4: Wrist Fractures
2.5
2.5. Analysis
Comparison 2: Risedronate 5 mg/day vs Placebo ‐ Subgroup of 1‐year studies, Outcome 5: Radiographic vertebral fractures
3.1
3.1. Analysis
Comparison 3: Risedronate 5 mg/day vs Placebo ‐ Subgroup of 2‐year studies, Outcome 1: Clinical vertebral fractures
3.2
3.2. Analysis
Comparison 3: Risedronate 5 mg/day vs Placebo ‐ Subgroup of 2‐year studies, Outcome 2: Non‐vertebral Fractures
3.3
3.3. Analysis
Comparison 3: Risedronate 5 mg/day vs Placebo ‐ Subgroup of 2‐year studies, Outcome 3: Hip Fractures
3.4
3.4. Analysis
Comparison 3: Risedronate 5 mg/day vs Placebo ‐ Subgroup of 2‐year studies, Outcome 4: Wrist Fractures
3.5
3.5. Analysis
Comparison 3: Risedronate 5 mg/day vs Placebo ‐ Subgroup of 2‐year studies, Outcome 5: Radiographic vertebral fractures
4.1
4.1. Analysis
Comparison 4: Risedronate 5 mg/day vs Placebo ‐ Subgroup of 3‐year studies, Outcome 1: Non‐vertebral Fractures
4.2
4.2. Analysis
Comparison 4: Risedronate 5 mg/day vs Placebo ‐ Subgroup of 3‐year studies, Outcome 2: Hip Fractures
4.3
4.3. Analysis
Comparison 4: Risedronate 5 mg/day vs Placebo ‐ Subgroup of 3‐year studies, Outcome 3: Wrist Fractures
4.4
4.4. Analysis
Comparison 4: Risedronate 5 mg/day vs Placebo ‐ Subgroup of 3‐year studies, Outcome 4: Radiographic vertebral fractures
5.1
5.1. Analysis
Comparison 5: Risedronate 5 mg/day vs Placebo ‐ Subgroup of bisphosphonate‐naive participants, Outcome 1: Clinical vertebral fractures
5.2
5.2. Analysis
Comparison 5: Risedronate 5 mg/day vs Placebo ‐ Subgroup of bisphosphonate‐naive participants, Outcome 2: Non‐vertebral fractures
5.3
5.3. Analysis
Comparison 5: Risedronate 5 mg/day vs Placebo ‐ Subgroup of bisphosphonate‐naive participants, Outcome 3: Hip fractures
5.4
5.4. Analysis
Comparison 5: Risedronate 5 mg/day vs Placebo ‐ Subgroup of bisphosphonate‐naive participants, Outcome 4: Wrist fractures
5.5
5.5. Analysis
Comparison 5: Risedronate 5 mg/day vs Placebo ‐ Subgroup of bisphosphonate‐naive participants, Outcome 5: Radiographic vertebral fractures
6.1
6.1. Analysis
Comparison 6: Risedronate 5 mg/day vs Placebo ‐ Sensitivity analyses with baseline denominators, Outcome 1: Clinical vertebral fractures
6.2
6.2. Analysis
Comparison 6: Risedronate 5 mg/day vs Placebo ‐ Sensitivity analyses with baseline denominators, Outcome 2: Non‐vertebral fractures
6.3
6.3. Analysis
Comparison 6: Risedronate 5 mg/day vs Placebo ‐ Sensitivity analyses with baseline denominators, Outcome 3: Hip fractures
6.4
6.4. Analysis
Comparison 6: Risedronate 5 mg/day vs Placebo ‐ Sensitivity analyses with baseline denominators, Outcome 4: Wrist fractures
6.5
6.5. Analysis
Comparison 6: Risedronate 5 mg/day vs Placebo ‐ Sensitivity analyses with baseline denominators, Outcome 5: Radiographic vertebral fractures
7.1
7.1. Analysis
Comparison 7: Risedronate 5 mg/day vs Placebo ‐ Sensitivity analyses with studies reporting fractures as efficacy outcomes, Outcome 1: Non‐vertebral fractures
7.2
7.2. Analysis
Comparison 7: Risedronate 5 mg/day vs Placebo ‐ Sensitivity analyses with studies reporting fractures as efficacy outcomes, Outcome 2: Hip fractures
7.3
7.3. Analysis
Comparison 7: Risedronate 5 mg/day vs Placebo ‐ Sensitivity analyses with studies reporting fractures as efficacy outcomes, Outcome 3: Wrist fractures
7.4
7.4. Analysis
Comparison 7: Risedronate 5 mg/day vs Placebo ‐ Sensitivity analyses with studies reporting fractures as efficacy outcomes, Outcome 4: Radiographic vertebral fractures
8.1
8.1. Analysis
Comparison 8: Risedronate 5 mg/day vs Placebo ‐ Sensitivity analyses excluding McClung 2001 study, Outcome 1: Clinical vertebral fractures
8.2
8.2. Analysis
Comparison 8: Risedronate 5 mg/day vs Placebo ‐ Sensitivity analyses excluding McClung 2001 study, Outcome 2: Non‐vertebral fractures
8.3
8.3. Analysis
Comparison 8: Risedronate 5 mg/day vs Placebo ‐ Sensitivity analyses excluding McClung 2001 study, Outcome 3: Hip fractures
8.4
8.4. Analysis
Comparison 8: Risedronate 5 mg/day vs Placebo ‐ Sensitivity analyses excluding McClung 2001 study, Outcome 4: Wrist fractures
8.5
8.5. Analysis
Comparison 8: Risedronate 5 mg/day vs Placebo ‐ Sensitivity analyses excluding McClung 2001 study, Outcome 5: Radiographic vertebral fractures
9.1
9.1. Analysis
Comparison 9: Risedronate 2.5 mg/day vs Placebo ‐ Base case, Outcome 1: Non‐vertebral fractures
9.2
9.2. Analysis
Comparison 9: Risedronate 2.5 mg/day vs Placebo ‐ Base case, Outcome 2: Radiographic vertebral fractures
9.3
9.3. Analysis
Comparison 9: Risedronate 2.5 mg/day vs Placebo ‐ Base case, Outcome 3: Withdrawals due to adverse events
9.4
9.4. Analysis
Comparison 9: Risedronate 2.5 mg/day vs Placebo ‐ Base case, Outcome 4: Serious adverse events
9.5
9.5. Analysis
Comparison 9: Risedronate 2.5 mg/day vs Placebo ‐ Base case, Outcome 5: Gastrointestinal adverse events
10.1
10.1. Analysis
Comparison 10: Risedronate 2.5 mg/day vs Placebo ‐ Subgroup of 1‐year studies, Outcome 1: Non‐vertebral fractures
10.2
10.2. Analysis
Comparison 10: Risedronate 2.5 mg/day vs Placebo ‐ Subgroup of 1‐year studies, Outcome 2: Radiographic vertebral fractures
11.1
11.1. Analysis
Comparison 11: Risedronate 2.5 mg/day vs Placebo ‐ Subgroup of 2‐year studies, Outcome 1: Non‐vertebral Fractures
11.2
11.2. Analysis
Comparison 11: Risedronate 2.5 mg/day vs Placebo ‐ Subgroup of 2‐year studies, Outcome 2: Radiographic vertebral fractures
12.1
12.1. Analysis
Comparison 12: Risedronate 2.5 mg/day vs Placebo ‐ Subgroup of bisphosphonate‐naive participants, Outcome 1: Non‐vertebral fractures
12.2
12.2. Analysis
Comparison 12: Risedronate 2.5 mg/day vs Placebo ‐ Subgroup of bisphosphonate‐naive participants, Outcome 2: Radiographic vertebral fractures
13.1
13.1. Analysis
Comparison 13: Risedronate 2.5 mg/day vs Placebo ‐ Sensitivity analyses with baseline denominators, Outcome 1: Non‐vertebral Fractures
13.2
13.2. Analysis
Comparison 13: Risedronate 2.5 mg/day vs Placebo ‐ Sensitivity analyses with baseline denominators, Outcome 2: Radiographic vertebral fractures
14.1
14.1. Analysis
Comparison 14: Risedronate 2.5 mg/day vs Placebo ‐ Sensitivity analyses with studies reporting fractures as efficacy outcomes, Outcome 1: Non‐vertebral Fractures
14.2
14.2. Analysis
Comparison 14: Risedronate 2.5 mg/day vs Placebo ‐ Sensitivity analyses with studies reporting fractures as efficacy outcomes, Outcome 2: Radiographic vertebral fractures
15.1
15.1. Analysis
Comparison 15: Risedronate 5 mg/day vs Risedronate 2.5 mg/day, Outcome 1: Non‐vertebral fractures
15.2
15.2. Analysis
Comparison 15: Risedronate 5 mg/day vs Risedronate 2.5 mg/day, Outcome 2: Radiographic vertebral fractures
15.3
15.3. Analysis
Comparison 15: Risedronate 5 mg/day vs Risedronate 2.5 mg/day, Outcome 3: Withdrawals due to adverse events
15.4
15.4. Analysis
Comparison 15: Risedronate 5 mg/day vs Risedronate 2.5 mg/day, Outcome 4: Serious adverse events
15.5
15.5. Analysis
Comparison 15: Risedronate 5 mg/day vs Risedronate 2.5 mg/day, Outcome 5: Gastrointestinal adverse events
16.1
16.1. Analysis
Comparison 16: Risedronate vs Active comparators‐ Clinical vertebral fractures, Outcome 1: Treatment vs Reference, Primary
16.2
16.2. Analysis
Comparison 16: Risedronate vs Active comparators‐ Clinical vertebral fractures, Outcome 2: Treatment vs Reference, Secondary
17.1
17.1. Analysis
Comparison 17: Risedronate vs Active comparators‐ Non‐vertebral fractures, Outcome 1: Treatment vs Reference, Primary
17.2
17.2. Analysis
Comparison 17: Risedronate vs Active comparators‐ Non‐vertebral fractures, Outcome 2: Treatment vs Reference, Secondary
18.1
18.1. Analysis
Comparison 18: Risedronate vs Active comparators‐ Hip fractures, Outcome 1: Treatment vs Reference, Primary
18.2
18.2. Analysis
Comparison 18: Risedronate vs Active comparators‐ Hip fractures, Outcome 2: Treatment vs Reference, Secondary
19.1
19.1. Analysis
Comparison 19: Risedronate vs Active comparators‐ Wrist fractures, Outcome 1: Treatment vs Reference, Primary
19.2
19.2. Analysis
Comparison 19: Risedronate vs Active comparators‐ Wrist fractures, Outcome 2: Treatment vs Reference, Secondary
20.1
20.1. Analysis
Comparison 20: Risedronate vs Active comparators‐ Radiographic vertebral fractures, Outcome 1: Treatment vs Reference, Primary
20.2
20.2. Analysis
Comparison 20: Risedronate vs Active comparators‐ Radiographic vertebral fractures, Outcome 2: Treatment vs Reference, Secondary
21.1
21.1. Analysis
Comparison 21: Risedronate vs Active comparators‐ Withdrawal due to adverse events, Outcome 1: Treatment vs Reference, Primary
21.2
21.2. Analysis
Comparison 21: Risedronate vs Active comparators‐ Withdrawal due to adverse events, Outcome 2: Treatment vs Reference, Secondary
22.1
22.1. Analysis
Comparison 22: Risedronate vs Active comparators‐ Serious adverse events, Outcome 1: Treatment vs Reference, Primary
22.2
22.2. Analysis
Comparison 22: Risedronate vs Active comparators‐ Serious adverse events, Outcome 2: Treatment vs Reference, Secondary
23.1
23.1. Analysis
Comparison 23: Risedronate vs Active comparators‐ Health‐related quality of life, Outcome 1: Treatment vs Reference, Secondary
24.1
24.1. Analysis
Comparison 24: Risedronate vs Active comparators‐ Gastrointestinal adverse events, Outcome 1: Treatment vs Reference, Primary
24.2
24.2. Analysis
Comparison 24: Risedronate vs Active comparators‐ Gastrointestinal adverse events, Outcome 2: Treatment vs Reference, Secondary
25.1
25.1. Analysis
Comparison 25: Risedronate vs Active comparators‐ Atypical femoral fractures, Outcome 1: Treatment vs Reference, Primary
25.2
25.2. Analysis
Comparison 25: Risedronate vs Active comparators‐ Atypical femoral fractures, Outcome 2: Treatment vs Reference, Secondary
26.1
26.1. Analysis
Comparison 26: Risedronate vs Active comparators‐ Acute phase reaction, Outcome 1: Treatment vs Reference, Secondary
27.1
27.1. Analysis
Comparison 27: Risedronate vs Active comparators‐ Osteonecrosis of the jaw, Outcome 1: Treatment vs Reference, Secondary
28.1
28.1. Analysis
Comparison 28: Risedronate vs Active comparators‐ Atrial fibrillation, Outcome 1: Treatment vs Reference, Secondary
29.1
29.1. Analysis
Comparison 29: Risedronate 5 mg/day vs therapeutic equivalent dose (TED)‐ All years, Outcome 1: Clinical vertebral fractures
29.2
29.2. Analysis
Comparison 29: Risedronate 5 mg/day vs therapeutic equivalent dose (TED)‐ All years, Outcome 2: Non‐vertebral fractures
29.3
29.3. Analysis
Comparison 29: Risedronate 5 mg/day vs therapeutic equivalent dose (TED)‐ All years, Outcome 3: Hip fractures
29.4
29.4. Analysis
Comparison 29: Risedronate 5 mg/day vs therapeutic equivalent dose (TED)‐ All years, Outcome 4: Wrist fractures
29.5
29.5. Analysis
Comparison 29: Risedronate 5 mg/day vs therapeutic equivalent dose (TED)‐ All years, Outcome 5: Radiographic vertebral fractures
29.6
29.6. Analysis
Comparison 29: Risedronate 5 mg/day vs therapeutic equivalent dose (TED)‐ All years, Outcome 6: Withdrawals due to adverse events
29.7
29.7. Analysis
Comparison 29: Risedronate 5 mg/day vs therapeutic equivalent dose (TED)‐ All years, Outcome 7: Serious adverse events
29.8
29.8. Analysis
Comparison 29: Risedronate 5 mg/day vs therapeutic equivalent dose (TED)‐ All years, Outcome 8: Gastrointestinal adverse events
29.9
29.9. Analysis
Comparison 29: Risedronate 5 mg/day vs therapeutic equivalent dose (TED)‐ All years, Outcome 9: Atypical femoral fracture
29.10
29.10. Analysis
Comparison 29: Risedronate 5 mg/day vs therapeutic equivalent dose (TED)‐ All years, Outcome 10: Acute phase reaction
29.11
29.11. Analysis
Comparison 29: Risedronate 5 mg/day vs therapeutic equivalent dose (TED)‐ All years, Outcome 11: Atrial fibrillation
29.12
29.12. Analysis
Comparison 29: Risedronate 5 mg/day vs therapeutic equivalent dose (TED)‐ All years, Outcome 12: Osteonecrosis of the jaw
30.1
30.1. Analysis
Comparison 30: Risedronate at unapproved dose regimen, Outcome 1: Clinical vertebral fractures
30.2
30.2. Analysis
Comparison 30: Risedronate at unapproved dose regimen, Outcome 2: Non‐vertebral fractures
30.3
30.3. Analysis
Comparison 30: Risedronate at unapproved dose regimen, Outcome 3: Hip fractures
30.4
30.4. Analysis
Comparison 30: Risedronate at unapproved dose regimen, Outcome 4: Wrist fractures
30.5
30.5. Analysis
Comparison 30: Risedronate at unapproved dose regimen, Outcome 5: Radiographic vertebral fractures
30.6
30.6. Analysis
Comparison 30: Risedronate at unapproved dose regimen, Outcome 6: Withdrawals due to adverse events
30.7
30.7. Analysis
Comparison 30: Risedronate at unapproved dose regimen, Outcome 7: Serious adverse events
30.8
30.8. Analysis
Comparison 30: Risedronate at unapproved dose regimen, Outcome 8: Gastrointestinal adverse events

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References

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    1. NCT00343252. Effect of teriparatide compared to risedronate on back pain in women with a spine fracture caused by osteoporosis [The effect of teriparatide compared with risedronate on back pain in postmenopausal women with osteoporotic vertebral fractures]. ClinicalTrials.gov Database. Provided by Eli Lilly and Company. July 12, 2010.
Harris 1999 {published data only}
    1. Harris ST, Watts NB, Genant HK, McKeever CD, Hangartner T, Keller M, et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. Vertebral Efficacy With Risedronate Therapy (VERT) Study Group. JAMA 1999;282(14):1344-52. - PubMed
    1. Ste-Marie L G, Sod E, Johnson T, Chines A. Five years of treatment with risedronate and its effects on bone safety in women with postmenopausal osteoporosis. Calcified Tissue International 2004;75:469-76. - PubMed
Harris 2001 {published data only}
    1. Harris ST, Eriksen EF, Davidson M, Ettinger MP, Moffett JA Jr, Baylink DJ, et al. Effect of combined risedronate and hormone replacement therapies on bone mineral density in postmenopausal women. Journal of Clinical Endocrinology & Metabolism 2001;86(5):1890-7. - PubMed
Hooper 2005 {published data only}
    1. Hooper MJ, Ebeling PR, Roberts AP, Graham JJ, Nicholson GC, D'Emden M, et al. Risedronate prevents bone loss in early postmenopausal women: a prospective randomized, placebo-controlled trial. Climacteric 2005;8:251-62. - PubMed
Hosking 2003 {published data only}
    1. Hosking D, Adami S, Felsenberg D, Andia JC, Valimaki M, Benhamou L, et al. Comparison of change in bone resorption and bone mineral density with once-weekly alendronate and daily risedronate: a randomised, placebo-controlled study. Current Medical Research and Opinion 2003;19(5):383-94. - PubMed
Kasukawa 2014 {published data only}
    1. Kasukawa Y, Miyakoshi N, Ebina T, Aizawa T, Hongo M, Nozaka K, et al. Effects of risedronate alone or combined with vitamin K2 on serum undercarboxylated osteocalcin and osteocalcin levels in postmenopausal osteoporosis. Journal of Bone and Mineral Metabolism 2014;32:290-7. - PubMed
Kato 2010 {published data only}
    1. Kato M, Takaishi H, Matsuzaki, H Kaneko K, Matsumoto M, Toyama Y, et al. Therapeutic effects of alfacalcidol, risedronate, and raloxifene on three-dimensional trabecular microarchitecture of cranial vertebral endplate in postmenopausal women: a prospective randomized trial using a multi-detector-raw CT imaging (SP28). In: Spine. 2010:10.
Kendler 2018 {published data only}
    1. Body JJ, Marin F, Kendler DL, Zerbini CA, López-Romero P, Möricke R. Efficacy of teriparatide compared with risedronate on FRAX® -defined major osteoporotic fractures: results of the VERO clinical trial. Osteoporosis International 2020;31:1935-42. - PMC - PubMed
    1. Kendler DL, Marin F, Zerbini CAF, Russo LA, Greenspan SL, Zikan V, et al. Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial. Lancet 2018;391:230-40. - PubMed
    1. NCT01709110. VERtebral fracture treatment comparisons in osteoporotic women (VERO) [Teriparatide and risedronate in the treatment of patients with severe postmenopausal osteoporosis: comparative effects on vertebral fractures]. ClinicalTrials.gov Database, provided by Eli Lilly and Company. January 23, 2018.
Leung 2005 {published data only}
    1. Leung JY, Ho AY, Ip TP, Lee G, Kung AW, Leung JYY, et al. The efficacy and tolerability of risedronate on bone mineral density and bone turnover markers in osteoporotic Chinese women: a randomized placebo-controlled study. Bone 2005;36(2):358-64. [MEDLINE: ] - PubMed
Li 2005 {published data only}
    1. Li Y, Zhang Z, Deng X, Chen L, Li Y, Zhang Z, et al. Efficacy and safety of risedronate sodium in treatment of postmenopausal osteoporosis. Journal of Huazhong University of Science and Technology 2005;25(5):527-9. [MEDLINE: ] - PubMed
Lim 2017 {published data only}
    1. Lim S J, Kim K, Park YS. Effect of osteoporosis medications on refracture and mortality following hip fracture surgery in postmenopausal women: a prospective randomized trial. Osteoporosis International 2017;28(1 Supplement):S250.
McClung 2001 {published data only}
    1. McClung MR, Geusens P, Miller PD, Zippel H, Bensen WG, Roux C, et al. Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group.. New England Journal of Medicine 2001;344(5):333-40. - PubMed
McClung 2012 {published data only}
    1. McClung MR, Balske A, Burgio DE, Wenderoth D, Recker RR. Treatment of postmenopausal osteoporosis with delayed-release risedronate 35 mg weekly for 2 years. Osteoporosis International 2013;24(1):301-10. - PMC - PubMed
    1. McClung MR, Miller PD, Brown JP, Zanchetta J, Bolognese MA, Benhamou CL, et al. Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet. Osteoporosis International 2012;23:267-76. - PMC - PubMed
    1. NCT00541658. A study of a 35 mg delayed release Formulation of Risedronate for Osteoporosis [A Non-inferiority Comparison of 35 mg delayed-release risedronate, given once-weekly either before or after breakfast, & 5 mg immediate-release risedronate, given once-daily before breakfast, in the treatment of postmenopausal osteoporosis]. ClinicalTrial.gov Database, provided by Warner Chilcott. June 21, 2011.
Mortensen 1998 {published data only}
    1. Mortensen L, Charles P, Bekker PJ, Digennaro J, Johnston CC Jr. Risedronate increases bone mass in an early postmenopausal population: two years of treatment plus one year of follow-up. Journal of Clinical Endocrinology & Metabolism 1998;83(2):396-402. - PubMed
Muscoso 2004 {published data only}
    1. Muscoso E, Puglisi N, Mamazza C, Lo Giudice M, Testai M, Abbate S, et al. Antiresorption therapy and reduction in fracture susceptibility in the osteoporotic elderly patient: open study. European Review for Medical and Pharmacological Sciences 2004;9:97-102. - PubMed
Nakamura 2013 {published data only}
    1. Nakamura Y, Nakano T, Masako Ito M, Hagino H, Hashimoto J, Tobinai M, et al. Clinical efficacy on fracture risk and Safety of 0.5 mg or 1 mg/month intravenous ibandronate versus 2.5 mg/day oral risedronate in patients with primary osteoporosis. Calcified Tissue International 2013;93:137-46. - PMC - PubMed
Narula 2012 {published data only}
    1. Narula R, Mujtaba T, Iraqi AA, Singh S. Effect of risedronate and strontium therapy on bone mineral density in postmenopausal osteoporosis. International Journal of Research in Ayurveda and Pharmacy 2012;3(4):543-7.
NCT00365456 {published data only}
    1. NCT00365456. Sequential treatment of postmenopausal women with primary osteoporosis(FP-001-IM) (PEAK) [An open label, international, multi centre, parallel group, phase iii b, randomised trial, investigating lumbar spine bone mineral density (BMD) changes in postmenopausal women with primary osteoporosis initially treated with 12 months of full length parathyroid hormone (PTH 1-84) followed by 12 months of treatment with risedronate followed by either 12 months]. clinicaltrials.gov/ct2/show/NCT00365456 (first received 20 July 2012).
NCT02063854 {published data only}
    1. NCT02063854. A phase II/III, double-blind, parallel group comparative study of oral administration of NE-58095 tablets [A phase 2/3, multicenter, randomized, double-blind, parallel group comparative study to evaluate the efficacy and safety of once-monthly oral administration of NE-58095DR Tablet (25 mg or 37.5 mg) versus once-daily oral administration of NE-58095IR tablet (2.5 mg) for the treatment of involutional osteoporosis]. clinicaltrials.gov/ct2/show/NCT02063854 (first received 23 February 2017).
Ohtori 2013 {published data only}
    1. Ohtori S, Inoue G, Orita S, Yamauchi K, Eguchi Y, Ochiai N, et al. Comparison of teriparatide and bisphosphonate treatment to reduce pedicle screw loosening after lumbar spinal fusion surgery in postmenopausal women with osteoporosis from a bone quality perspective. Spine 2013;38(8):E487-92. - PubMed
Paggiosi 2014a {published data only}
    1. Paggiosi M A, Peel N, McCloskey E, Walsh JS, Eastell R. Comparison of the effects of three oral bisphosphonate therapies on the peripheral skeleton in postmenopausal osteoporosis: the TRIO study. Osteoporosis International 2014;25(12):2729-41. - PubMed
Reginster 2000 {published data only}
    1. Reginster J, Minne HW, Sorensen OH, Hooper M, Roux C, Brandi ML, et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporosis International 2000;11(1):83-91. - PubMed
    1. Sorensen OH, Crawford GM, Mulder H, Hosking DJ, Gennari C, Mellstrom D, et al. Long-term efficacy of risedronate: a 5-year placebo-controlled clinical experience. Bone 2003;32(2):120-6. - PubMed
Reid 2006 {published data only}
    1. Reid DM, Hosking D, Kendler D, Brandi ML, Wark JD, Marques-Neto JF, et al. A comparison of the effect of alendronate and risedronate on bone mineral density in postmenopausal women with osteoporosis: 24-Month results from FACTS-International. International Journal of Clinical Practice 2008;62(4):575-84. - PubMed
    1. Reid D M, Hosking D, Kendler D, Brandi M L, Wark J D, Weryha G, et al. Alendronic acid produces greater effects than risedronic acid on bone density and turnover in postmenopausal women with osteoporosis: Results of FACTS 1 -International. Clinical Drug Investigation 2006;26(2):63-74. - PubMed
Rosen 2005 {published data only}
    1. Bonnick S, Saag KG, Kiel DP, McClung M, Hochberg M, Burnett SA, et al. Comparison of weekly treatment of postmenopausal osteoporosis with alendronate versus risedronate over two years. Journal of Clinical Endocrinology and Metabolism 2006;91(7):2631-7. - PubMed
    1. Rosen CJ, Hochberg MC, Bonnick SL, McClung M, Miller P, Broy S, et al. Treatment with once-weekly alendronate 70 mg compared with once-weekly risedronate 35 mg in women with postmenopausal osteoporosis: a randomized double-blind study. Journal of Bone and Mineral Research 2005;20(1):141-51. - PubMed
Roux 2014 {published data only}
    1. NCT00919711. Study to evaluate the safety and efficacy of denosumab and Actonel® in post menopausal women transitioned from alendronate therapy [A randomized open-label study to evaluate the safety and efficacy of denosumab and monthly Actonel® therapies in postmenopausal women transitioned from weekly or daily alendronate therapy]. ClinicalTrials.gov Database, provided by Amgen. December 12, 2012.
    1. Roux CHofbauer LC, Ho PR, Wark J D, Zillikens MC, Fahrleitner-Pammer A, et al. Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: efficacy and safety results from a randomized open-label study. Bone 2014;58:48-54. - PubMed
Sarioglu 2006 {published data only}
    1. Sarioglu M, Tuzun C, Unlu Z, Tikiz C, Taneli F, Uyanik BS. Comparison of the effects of alendronate and risedronate on bone mineral density and bone turnover markers in postmenopausal osteoporosis. Rheumatology international 2006;26:195-200. - PubMed
Tanaka 2017 {published data only}
    1. Tanaka S, Miyazaki T, Uemura Y, Miyakawa N, Gorai I, Nakamura T, et al. Comparison of concurrent treatment with vitamin K 2 and risedronate compared with treatment with risedronate alone in patients with osteoporosis: Japanese Osteoporosis Intervention Trial-03. Journal of Bone and Mineral Metabolism 2017;35(4):385-95. - PubMed
Välimäki 2007 {published data only}
    1. Välimäki MJ, Farrerons-Minguella J, Halse J, Kröger H, Maroni M, Mulder H, et al. Effects of risedronate 5 mg/d on bone mineral density and bone turnover markers in late-postmenopausal women with osteopenia: a multinational, 24-month, randomized, double-blind, placebo-controlled, parallel-group, phase III trial. Clinical Therapeutics 2007;29(9):1937-49. - PubMed
Yanik 2008 {published data only}
    1. Yanik B, Bavbek N, Yangk T, Inegol I, Kanbay M, Turgut FH, et al. The effect of alendronate, risedronate, and raloxifene on renal functions, based on the Cockcroft and Gault method, in postmenopausal women. Renal Failure 2007;29:471-6. - PubMed
    1. Yanik B, Kulcu DG. The effect of raloxifene, alendronate and risedronate on serum lipid profile in postmenopausal women. Turkiye Fiziksel Tip ve Rehabilitasyon Dergisi 2008;54(1):4-7.

References to studies excluded from this review

Adachi 2001 {published data only}
    1. Adachi JD, Adami S, Miller PD, Olszynski W P, Kendler DL, Silverman SL, et al. Tolerability of risedronate in postmenopausal women intolerant of alendronate. Aging - Clinical and Experimental Research 2001;13:347-54. - PubMed
Altintas 2007 {published data only}
    1. Altintas F, Ozkut AT, Beyzadeoglu T, Eren A, Guven M. The effect of risedronate treatment on bone turnover markers in patients with hip fracture. Acta orthopaedica et traumatologica turcica 2007;41:132-5. - PubMed
Anastasilakis 2008b {published data only}
    1. Anastasilakis AD, Goulis D G, Polyzos S A, Gerou S, Koukoulis G, Kita M, et al. Serum osteoprotegerin and RANKL are not specifically altered in women with postmenopausal osteoporosis treated with teriparatide or risedronate: a randomized, controlled trial. Hormone and Metabolic Research 2008;40(4):281-5. - PubMed
Article in Dutch 2001 {published data only}
    1. No authors listed Publication in Dutch. Risedronate in the treatment and prevention of postmenopausal osteoporosis [Risedronaat, behandeling en preventie van postmenopauzale osteoporose]. Geneesmiddelenbulletin Medische Bulletin Hulpmiddelen 2001;35(9):102-3.
Bahlous 2009 {published data only}
    1. Bahlous A, Bouzid K, Sahli H, Sallami S, Abdelmoula J. Effects of risedronate on bone turnover markers in osteoporotic postmenopausal women: comparison of two protocols of treatment. Tunisie Medicale 2009;87:380-1. - PubMed
Bala 2013 {published data only}
    1. Bala Y, Chapurlat R, Felsenberg D, Thomas T, LaRoche M, Morris E, et al. Risedronate slows or partly reverses microarchitecture deterioration depending on whether remodelling is perturbed or in steady state. Osteoporosis International 2013;24:S58-59.
Borah 2004 {published data only}
    1. Borah B, Dufresne TE, Chmielewski PA, Johnson TD, Chines A, Manhart MD. Risedronate preserves bone architecture in postmenopausal women with osteoporosis as measured by three-dimensional microcomputed tomography. Bone 2004;34:736-46. - PubMed
Borah 2005 {published data only}
    1. Borah B, Ritman EL, Dufresne TE, Borah B, Ritman EL, Dufresne TE, et al. The effect of risedronate on bone mineralization as measured by micro-computed tomography with synchrotron radiation: correlation to histomorphometric indices of turnover. Bone 2005;37:1-9. - PubMed
Borah 2010 {published data only}
    1. Borah B, Dufresne T, Nurre J, Phipps R, Chmielewski P, Wagner L, et al. Risedronate reduces intracortical porosity in women with osteoporosis. Journal of Bone and Mineral Research 2010;25:41-7. - PubMed
Borah 2010a {published data only}
    1. Borah B, Dufresne T, Nurre J, Chmielewski P, Phipps R, McCullough L, et al. Risedronate reduces intracortical porosity in postmenopausal women with osteoporosis as measured by a new 3D Micro-CT method. Bone 2010;46:S61. - PubMed
Brown 2014 {published data only}
    1. Brown JP, Roux C, Ho PR, Bolognese MA, Hall J, Bone HG, et al. Denosumab significantly increases bone mineral density and reduces bone turnover compared with monthly oral ibandronate and risedronate in postmenopausal women who remained at higher risk for fracture despite previous suboptimal treatment with an oral bisphosphonate. Osteoporosis International 2014;25:1953-61. - PubMed
Caffarelli 2010 {published data only}
    1. Caffarelli C, Gonnelli S, Tanzilli L, Martini G, Nuti R. Apparent bone mineral density at femoral neck in the monitoring the early effects of teriparatide. Bone 2010;47:S203-4.
Carlino 2011 {published data only}
    1. Carlino G, Cozzolongo A. Effects of intravenous zoledronic acid following subcutaneous teriparatide in postmenopausal osteoporosis. Bone 2011;48:S220.
Chapurlat 2011 {published data only}
    1. Chapurlat R, Seeman E. Risedronate reduces cortical structural decay during menopause, probably by reducing intracortical porosity. Osteoporosis International 2011;22(Suppl 1):S100.
Chung 2009 {published data only}
    1. Chung YS, Lim SK, Chung HY, Lee I K, Park IH, Kim GS, et al. Comparison of monthly ibandronate versus weekly risedronate in preference, convenience, and bone turnover markers in Korean postmenopausal osteoporotic women. Calcified Tissue International 2009;85:389-97. - PMC - PubMed
D'Amelio 2008 {published data only}
    1. D'Amelio P, Grimaldi A, Di Bella S, Tamone C, Brianza SZ, Ravazzoli MG, et al. Risedronate reduces osteoclast precursors and cytokine production in postmenopausal osteoporotic women. Journal of Bone and Mineral Research 2008;23:373-9. - PubMed
Dane 2008 {published data only}
    1. Dane C, Dane B, Cetin A, Erginbas M. Effect of risedronate on biochemical marker of bone resorption in postmenopausal women with osteoporosis or osteopenia. Gynecological Endocrinology 2008;24:207-13. - PubMed
Delmas 2007 {published data only}
    1. Delmas PD, Vrijens B, Eastell R, Roux C, Pols HA, Ringe JD, et al. Effect of monitoring bone turnover markers on persistence with risedronate treatment of postmenopausal osteoporosis. Journal of clinical endocrinology and metabolism 2007;92:1296-304. - PubMed
Dufresne 2003 {published data only}
    1. Dufresne TE, Chmielewski PA, Manhart M, D, Johnson TD, Borah B, et al. Risedronate preserves bone architecture in early postmenopausal women in 1 year as measured by three-dimensional microcomputed tomography. Calcified Tissue International 2003;73:423-32. - PubMed
Duque 2009 {published data only}
    1. Duque G, Li W, Adams M, Xu S, Phipps R. Effects of risedronate on bone marrow adipocytes in postmenopausal women. Bone 2009;44(Suppl 1):S53. - PubMed
Duque 2011 {published data only}
    1. Duque G, Li W, Adams M, Xu S, Phipps R. Effects of risedronate on bone marrow adipocytes in postmenopausal women. Osteoporosis International 2011;22:1547-53. - PubMed
Durchschlag 2006 {published data only}
    1. Durchschlag E, Paschalis EP, Zoehrer R, Roschger P, Fratzl P, Recker R, et al. Bone material properties in trabecular bone from human iliac crest biopsies after 3- and 5-year treatment with risedronate. Journal of Bone and Mineral Research 2006;21:1581-90. - PubMed
Eastell 2003 {published data only}
    1. Eastell R, Barton I, Hannon RA, Chines A, Garnero P, Delmas PD. Relationship of early changes in bone resorption to the reduction in fracture risk with risedronate. Journal of Bone and Mineral Research 2003;18:1051-6. - PubMed
Eastell 2010 {published data only}
    1. Eastell R, Vrijens B, Cahall D, Roux C, Ringe J, Garnero P, et al. Relationships between osteoporosis medication adherence, surrogate marker outcomes and non-vertebral fracture incidence. Bone 2010;47:S200-1.
Eastell 2011 {published data only}
    1. Eastell R, Vrijens B, Cahall DL, Ringe JD, Garnero P, Watts NB. Bone turnover markers and bone mineral density response with risedronate therapy: relationship with fracture risk and patient adherence. Journal of Bone and Mineral Research 2011;26:1662-9. - PubMed
Eastell 2013 {published data only}
    1. Eastell R, Paggiosi M, Peel N, McCloskey E, Walsh J. The effects of oral bisphosphonate therapy on the peripheral skeleton in postmenopausal osteoporosis: The trio study. Journal of Bone and Mineral Research 2013;28(S1):Available at https://www.asbmr.org/Meetings/AnnualMeeting/AbstractDetail.aspx?aid=51d.... Accessed July 08, 2020.
Eriksen 2002 {published data only}
    1. Eriksen EF, Melsen F, Sod E, Barton I, Chines A. Effects of long-term risedronate on bone quality and bone turnover in women with postmenopausal osteoporosis. Bone 2002;31(5):620-5. - PubMed
Fujita 2009 {published data only}
    1. Fujita T, Ohue M, Fujii Y, Miyauchi A, Takagi Y. Comparison of the analgesic effects of bisphosphonates: etidronate, alendronate and risedronate by electroalgometry utilizing the fall of skin impedance. Journal of Bone and Mineral Metabolism 2009;27:234-9. - PubMed
Geusens 2017 {published data only}
    1. Geusens P, Marin F, Kendler L, Russo L, Zerbini CA, Greenspan S, et al. Teriparatide compared with risedronate and the risk of fractures in subgroups of postmenopausal women with severe osteoporosis: The VERO Trial. Journal of Bone and Mineral Research 2017;32(Supplement 1):S22. - PubMed
Goa 1998 {published data only}
    1. Goa KL, Balfour JA. Risedronate. Drugs and Aging 1998;13:83-92. - PubMed
Gonnelli 2006 {published data only}
    1. Gonnelli S, Martini G, Caffarelli C, Salvadori S, Cadirni A, Montagnani A, et al. Teriparatide's effects on quantitative ultrasound parameters and bone density in women with established osteoporosis. Osteoporosis International 2006;17:1524-31. - PubMed
Gossiel 2010 {published data only}
    1. Gossiel F, Hannon R, Eastell R. The effect of 3 orally-administered bisphosphonates on the resorption of type I collagen in postmenopausal osteoporosis. Bone 2010;47:S204.
Gossiel 2016 {published data only}
    1. Gossiel F, Hoyle C, McCloskey EV, Naylor KE, Walsh J, Peel N. The effect of bisphosphonate treatment on osteoclast precursor cells in postmenopausal osteoporosis: The TRIO study. Bone 2016;92:94-9. - PubMed
Gossiel 2018 {published data only}
    1. Gossiel F, Paggiosi M, Naylor K, McCloskey E, Walsh J, Peel N, et al. The effect of bisphosphonates on bone turnover and bone balance in postmenopausal women with osteoporosis: The T-score bone marker approach in the trio study. Osteoporosis International 2018;29(Supplement 2):S621-2. - PubMed
Hadji 2011 {published data only}
    1. Hadji P, Dalsky GP. Effect of teriparatide compared with risedronate on reduction of back pain and new vertebral fractures in postmenopausal women with osteoporotic vertebral fractures. Bone 2011;48:S228. - PubMed
Hadji 2011a {published data only}
    1. Hadji P, Zanchetta JR, Russo LA, Recknor CP, Saag KG, Mckiernan FE, et al. Effect of teriparatide compared with risedronate on back pain and incident vertebral fractures in postmenopausal women with osteoporotic vertebral fractures. Bone 2011;48:S82. - PubMed
Hagino 2014 {published data only}
    1. Hagino H, Yoshida S, Hashimoto J, Matsunaga M, Tobinai M, Nakamura T. Increased bone mineral density with monthly intravenous ibandronate contributes to fracture risk reduction in patients with primary osteoporosis: three-year analysis of the MOVER study. Calcified Tissue International 2014;95(6):557-63. - PMC - PubMed
Harris 1999a {published data only}
    1. Harris ST, Wasnich R, Ettinger M, Davidson M, Bosch L, Chines A. The effects of risedronate plus estrogen compared with estrogen alone in postmenopausal women. Journal of Bone and Mineral Research 1999;14(Suppl 1):S404.
Hofbauer 2013 {published data only}
    1. Hofbauer LC, Fahrleitnerpammer A, Ho PR, Hawkins F, Roux C, Micaelo M, et al. Efficacy and safety of denosumab vs. Risedronate in postmenopausal women suboptimally adherent to alendronate: Results from a randomized open-label study. Osteoporosis International 2013;24(1 Suppl 1):S218-S219.
Hongo 2015 {published data only}
    1. Hongo M, Miyakoshi N, Kasukawa Y, Ishikawa Y, Shimada Y. Additive effect of elcatonin to risedronate for chronic back pain and quality of life in postmenopausal women with osteoporosis: a randomized controlled trial. Journal of Bone and Mineral Metabolism 2015;33:432-9. - PubMed
Hooper 1999 {published data only}
    1. Hooper M, Ebeling P, Roberts A. Risedronate prevents bone loss in early postmenopausal women. Calcified Tissue International 1999;64:80.
Hosking 2009 {published data only}
    1. Hosking D, Brandi M, Diaz-Curiel M, Felsenberg D, Hyldstrup LH. One year of treatment with PTH (1-84) and the change in lumbar spine BMD in postmenopausal women with primary osteoporosis after pre-treatment with a bisphosphonate. Bone 2009;44:S428.
Iizuka 2008 {published data only}
    1. Iizuka T, Matsukawa M. Potential excessive suppression of bone turnover with long-term oral bisphosphonate therapy in postmenopausal osteoporotic patients. Climacteric 2008;11:287-95. - PubMed
Ilter 2006 {published data only}
    1. Ilter E, Karalok H, Tufekci EC, Batur O. Efficacy and acceptability of risedronate 5 mg daily compared with 35 mg once weekly for the treatment of postmenopausal osteoporosis. Climacteric 2006;9:129-34. - PubMed
Imai 2017 {published data only}
    1. Imai T, Tanaka S, Kawakami K, Miyazaki T, Hagino H, Shiraki M, et al. Health state utility values and patient-reported outcomes before and after vertebral and non-vertebral fractures in an osteoporosis clinical trial. Osteoporosis International 2017;28(6):1893-901. - PubMed
Iwamoto 2016 {published data only}
    1. Iwamoto J, Okano H, Furuya T, Urano T, Hasegawa M, Hirabayashi H, et al. Patient preference for monthly bisphosphonate versus weekly bisphosphonate in a cluster-randomized, open-label, crossover trial: Minodroate Alendronate/Risedronate Trial in Osteoporosis (MARTO). Journal of Bone and Mineral Metabolism 2016;34:201-8. - PubMed
Kanis 2005 {published data only}
    1. Kanis J A, Barton I P, Johnell O. Risedronate decreases fracture risk in patients selected solely on the basis of prior vertebral fracture. Osteoporosis International 2005;16:475-82. - PubMed
Karadag‐Saygi 2011 {published data only}
    1. Karadag-Saygi E, Akyuz G, Bizargity P, Ay P. The effect of risedronate treatment on serum osteoprotegerin and bone marker levels in postmenopausal women with osteoporosis. Gynecological Endocrinology 2011;27:1033-6. - PubMed
Kendler 2009 {published data only}
    1. Kendler DL, Ringe JD, Ste-Marie L G, Vrijens B, Taylor E B, Delmas PD. Risedronate dosing before breakfast compared with dosing later in the day in women with postmenopausal osteoporosis. Osteoporosis International 2009;20:1895-902. - PubMed
Kendler 2017 {published data only}
    1. Kendler DL, Zerbini C, Russo L, Greenspan S, Zikan V, Bagur A, et al. Effects of 24 months treatment of teriparatide compared with risedronate on new fractures in postmenopausal women with severe osteoporosis: a randomized, double-dummy, clinical trial. Osteoporosis International 2017;28(Suppl 1):S69-70.
Kushida 2004 {published data only}
    1. Kushida K, Fukunaga M, Kishimoto H, Shiraki M, Itabashi A, Inoue T, et al. A comparison of incidences of vertebral fracture in Japanese patients with involutional osteoporosis treated with risedronate and etidronate: a randomized, double-masked trial. Journal of Bone and Mineral Metabolism 2004;22:469-78. - PubMed
Lanza 2000 {published data only}
    1. Lanza FL, Hunt RH, Thomson A BR, Provenza JM, Blank MA. Endoscopic comparison of esophageal and gastroduodenal effects of risedronate and alendronate in postmenopausal women. Gastroenterology 2000;119:631-8. - PubMed
Lanza 2000a {published data only}
    1. Lanza FL, Rack MF, Li Z, Krajewski SA, Blank MA. Placebo-controlled, randomized, evaluator-blinded endoscopy study of risedronate vs. aspirin in healthy postmenopausal women. Alimentary Pharmacology and Therapeutics 2000;14:1663-70. - PubMed
Licata 1997 {published data only}
    1. Licata AA. Bisphosphonate therapy. American Journal of the Medical Sciences 1997;313(1):17-22. - PubMed
Masud 2009 {published data only}
    1. Masud T, McClung M, Geusens P. Reducing hip fracture risk with risedronate in elderly women with established osteoporosis. Clinical Interventions in Aging 2009;4:445-9. - PMC - PubMed
Maugeri 2005 {published data only}
    1. Maugeri D, Mamazza C, Lo Giudice F, Puglisi N, Muscoso EG, Rizzotto M, et al. Interleukin-18 (IL-18) and matrix metalloproteinase-9 (MMP-9) in post-menopausal osteoporosis. Archives of Gerontology and Geriatrics 2005;40(3):299-305. - PubMed
McClung 1996 {published data only}
    1. McClung M, Bensen W. Risedronate treatment of postmenopausal women with low bone mass: preliminary data. Osteoporosis International 1996;6(Suppl 1):257.
McClung 1998 {published data only}
    1. McClung M, Bensen W G, Bolognese M, Bonnick S, Ettinger M, Harris ST. Risedronate increases bone mineral density at the hip, spine and radius in postmenopausal women with low bone mass. Osteoporosis International 1998;8(Suppl 3):111.
McClung 2010a {published data only}
    1. McClung M, Bolognese M, Miller P, Sarley J, McCullough L, Brown J, et al. Bmd response to a novel delayed-release risedronate 35 mg once-a-week formulation taken with or without breakfast: One year results. Journal of Bone and Mineral Research 2010;25(S1):S124.
McClung 2010b {published data only}
    1. McClung MR, Bolognese MA, Miller PD, Brown JP, Recker RR. BMD response to delayed-release risedronate 35 mg once-a-week formulation taken with or without breakfast (Poster Number 067). Journal of Clinical Densitometry 2010;13:132.
McClung 2010c {published data only}
    1. McClung MR, Zanchetta JR, Benhamou CL, Balske A, Sarley J, Recker RR. Effect of a delayed-release risedronate 35 mg once-a-week formulation taken with or without breakfast on BMD. In: Osteoporosis International. Vol. 21. 2010:S25. - PubMed
McClung 2011 {published data only}
    1. McClung MR, Miller PD, Brown JP, Zanchetta J, Bolognese MA, Benhamou CL, et al. Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet. Osteoporosis International 2011;21(Suppl 1):1-10. - PMC - PubMed
Mellstrom 2004 {published data only}
    1. Mellstrom DD, Sorensen OH, Goemaere S, Roux C, Johnson TD, Chines A A, et al. Seven years of treatment with risedronate in women with postmenopausal osteoporosis. Calcified Tissue International 2004;75:462-8. - PubMed
Miller 1999 {published data only}
    1. Miller E, Roux C, McClung M, Adami S, Eastell R, Ethgen D. Risedronate reduces hip fractures in patients with low femoral neck bone mineral density [abstract]. Arthritis and Rheumatism 1999;42:S287.
Miller 1999a {published data only}
    1. Miller PD, Brown J P, Siris ES, Hoseyni M S, Axelrod DW, Bekker P J. A randomized, double-blind comparison of risedronate and etidronate in the treatment of Paget’s disease of bone. Paget’s Risedronate/Etidronate Study Group. American Journal of Medicine 1999;106(5):513–20. - PubMed
Minisola 2019 {published data only}
    1. Minisola S, Marin F, Kendler DL, Geusens P, Zerbini C A F, Russo LA, et al. Serum 25-hydroxy-vitamin D and the risk of fractures in the teriparatide versus risedronate VERO clinical trial. Archives of Osteoporosis 2019;14(1):10. - PubMed
Ohtori 2012 {published data only}
    1. Ohtori S, Inoue G, Orita S, Yamauchi K, Eguchi Y, Ochiai N, et al. Teriparatide accelerates lumbar posterolateral fusion in women with postmenopausal osteoporosis: prospective study. Spine 2012;37:E1464-8. - PubMed
Oktem 2008 {published data only}
    1. Oktem M, Atar I, Zeyneloglu HB, Yildirir A, Kuscu E, Muderrisoglu H. Raloxifene has favourable effects on metabolic parameters but has no effect on left ventricular function in postmenopausal women. Pharmacological Research 2008;57:364-8. - PubMed
Oliveira 2015 {published data only}
    1. Oliveira LG, Eis SR, Neto H M, e Moraes FB, Pires L A, Vasconcelos JW. Use of risedronate for consolidation and callus formation in Colles fractures in postmenopausal women: SOLID study. Revista Brasileira de Ortopedia 2015;50:274-82. - PMC - PubMed
Oral 2015 {published data only}
    1. Oral A, Lorenc R. Compliance, persistence, and preference outcomes of postmenopausal osteoporotic women receiving a flexible or fixed regimen of daily risedronate: a multicenter, prospective, parallel group study. Acta Orthopaedica et Traumatologica Turcica 2015;49:67-74. - PubMed
Paggiosi 2014b {published data only}
    1. Paggiosi MA, Walsh JS, Peel NF, McCloskey EV, Eastell R. A comparison of the effects of three oral bisphosphonates on the peripheral skeleton in postmenopausal osteoporosis: The trio study. Osteoporosis International 2014;25(6 Supplement):S692. - PubMed
Palomba 2005 {published data only}
    1. Palomba S, Orio F, Manguso F, Falbo A, Russo T, Tolino A, et al. Efficacy of risedronate administration in osteoporotic postmenopausal women affected by inflammatory bowel disease. Osteoporosis International 2005;16:1141-9. - PubMed
Pawlowski 2015 {published data only}
    1. Pawlowski JW, Martin BR, McCabe GP, McCabe L, Jackson GS, Peacock M, et al. Impact of equol-producing capacity and soy-isoflavone profiles of supplements on bone calcium retention in postmenopausal women: a randomized crossover trial. American Journal of Clinical Nutrition 2015;102:695-703. - PMC - PubMed
Peris 2013 {published data only}
    1. Peris P, Atkinson EJ, Gossl M, Kane TL, McCready L K, Lerman A, et al. Effects of bisphosphonate treatment on circulating osteogenic endothelial progenitor cells in postmenopausal women. Mayo Clinic Proceedings 2013;88:46-55. - PMC - PubMed
Racewicz 2007 {published data only}
    1. Racewicz AJ, Schofield PJ, Cahall DL, Cline GA, Burgio DE. Monthly dosing with risedronate 50 mg on three consecutive days a month compared with daily dosing with risedronate 5 mg: a 6-month pilot study. Current Medical Research and Opinion 2007;23:3079-89. - PubMed
Ralston 2011 {published data only}
    1. Ralston SH, Binkley N, Boonen S, Kiel DP, Reginster JY, Roux C, et al. Randomized trial of alendronate plus vitamin D3 versus standard care in osteoporotic postmenopausal women with vitamin D insufficiency. Calcified Tissue International 2011;88:485-94. - PubMed
Recker 2011 {published data only}
    1. Recker R, Valter I, Maasalu K, Magaril C, Man Z, Zanchetta JR, et al. Bone safety of a novel delayed-release risedronate 35 mg once-a-week assessed by bone histology and histomorphometry. Journal of Bone and Mineral Research 2011;26(S1):S361-2.
Recker 2015 {published data only}
    1. Recker RR, Ste-Marie LG, Chavassieux P, McClung MR, Lundy MW. Bone safety with risedronate: histomorphometric studies at different dose levels and exposure. Osteoporosis International 2015;26:327-37. - PubMed
Reginster 2001 {published data only}
    1. Reginster JY. Risedronate increases bone mineral density and reduces the vertebral fracture incidence in postmenopausal women. Clinical and Experimental Rheumatology 2001;19(2):121-2. - PubMed
Reszka 1999 {published data only}
    1. Reszka AA, Halasy-Nagy JM, Masarachia PJ, Rodan GA. Bisphosphonates act directly on the osteoclast to induce caspase cleavage of mst1 kinase during apoptosis. A link between inhibition of the mevalonate pathway and regulation of an apoptosis-promoting kinase. Journal of Biological Chemistry 1999;274(49):34967-73. - PubMed
Ribot 1999 {published data only}
    1. Ribot C, Smith R, Fogelman I, Pack S, Ethgen D. Risedronate increases bone mineral density and is well tolerated in postmenopausal women with low bone mineral density. Journal of Bone and Mineral Research 1999;14:S163.
Roux 2004 {published data only}
    1. Roux C, Seeman E, Eastell R, Adachi J, Jackson RD, Felsenberg D, et al. Efficacy of risedronate on clinical vertebral fractures within six months. Current Medical Research and Opinion 2004;20:433-9. - PubMed
Roux 2013 {published data only}
    1. Roux C, Fahrleitner-Pammer A, Ho PR, Hawkins F, Hofbauer LC, Micaelo M, et al. Denosumab versus risedronate: efficacy and safety in postmenopausal women suboptimally adherent to alendronate therapy in a randomized open-label study. Annals of Rheumatic Diseases 2013;72:A306. - PubMed
Sebba 2004 {published data only}
    1. Sebba AI, Bonnick SL, Kagan R, Thompson DE, Skalky C S, Chen E, et al. Response to therapy with once-weekly alendronate 70 mg compared to once-weekly risedronate 35 mg in the treatment of postmenopausal osteoporosis. Current Medical Research and Opinion 2004;20:2031-41. - PubMed
Seeman 2010a {published data only}
    1. Seeman E, Chapurlat R, Cheung A, Felsenberg D, La-Roche M, Reeve J, et al. Risedronate reduces micro-structural deterioration of cortical bone accompanying menopause. Osteoporosis International 2010;21(Suppl 1):S9.
Seibel 2004 {published data only}
    1. Seibel MJ, Naganathan V, Barton I, Grauer A. Relationship between pretreatment bone resorption and vertebral fracture incidence in postmenopausal osteoporotic women treated with risedronate. Journal of Bone and Mineral Research 2004;19:323-9. - PubMed
Shiraki 2003 {published data only}
    1. Shiraki M, Fukunaga M, Kushida K, Kishimoto H, Taketani Y, Minaguchi H, et al. A double-blind dose-ranging study of risedronate in Japanese patients with osteoporosis (a study by the Risedronate Late Phase II Research Group). Osteoporosis International 2003;14:225-34. - PubMed
Singer 1995 {published data only}
    1. Singer FR, Minoofar PN. Bisphosphonates in the treatment of disorders of mineral metabolism. Therapeutic Advances in Endocrinology and Metabolism 1995;6:259-88. - PubMed
Ste‐Marie 2009 {published data only}
    1. Ste-Marie LG, Brown J P, Beary JF, Matzkin E, Darbie LM, Burgio DE, et al. Comparison of the effects of once-monthly versus once-daily risedronate in postmenopausal osteoporosis: a phase II, 6-month, multicenter, randomized, double-blind, active-controlled, dose-ranging study. Clinical Therapeutics 2009;31:272-85. - PubMed
Stovall 2010 {published data only}
    1. Stovall DW, Beard MK, Barbier S, Chen E, Rosenberg E, e Papp AE. Response to oral bisphosphonates in subgroups of younger and older postmenopausal women. Journal of Women's Health 2010;19:491-7. - PubMed
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    1. Takada J, Iba K, Imoto K, Yamashita T. Changes in bone resorption markers among Japanese patients with postmenopausal osteoporosis treated with alendronate and risedronate. Journal of Bone and Mineral Metabolism 2007;25:142-6. - PubMed
Tanaka 2014 {published data only}
    1. Tanaka S, Miyazaki T, Uemura Y, Kuroda T, Miyakawa N, Nakamura T, et al. Design of a randomized clinical trial of concurrent treatment with vitamin K2 and risedronate compared to risedronate alone in osteoporotic patients: Japanese Osteoporosis Intervention Trial-03 (JOINT-03). Journal of Bone and Mineral Metabolism 2014;32:298-304. - PubMed
Taquet 1996 {published data only}
    1. Taquet AN, Clemmensen B. A three-year double-blind placebo-controlled study of risedronate in postmenopausal osteoporosis. Osteoporosis International 1996;6(Suppl 1):262.
Thomson 2002 {published data only}
    1. Thomson AB, Marshall JK, Hunt RH, Provenza JM, Lanza FL, Royer MG, et al. 14 Day endoscopy study comparing risedronate and alendronate in postmenopausal women stratified by Helicobacter pylori status. Journal of Rheumatology 2002;29:1965-74. - PubMed
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    1. Watts NB. Treatment of osteoporosis with bisphosphonates. Endocrinology and Metabolism Clinics of North America 1998;27(2):419-39. - PubMed
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    1. Watts N, Roux C, Genant H, Adami S, Hangartner T, Miller P. Risedronate reduces vertebral fracture risk after the first year of treatment in postmenopausal women with established osteoporosis. Journal of Bone and Mineral Research 1999;14(Suppl 1):S136.
Watts 2003 {published data only}
    1. Watts NB, Josse RG, Hamdy RC, Hughes RA, Manhart MD, Barton I, et al. Risedronate prevents new vertebral fractures in postmenopausal women at high risk. Journal of Clinical Endocrinology and Metabolism 2003;88:542-9. - PubMed
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    1. Zegels B, Eastell R, Russell RG, Ethgen D, Roumagnac I, Collette J, et al. Effect of high doses of oral risedronate (20 mg/day) on serum parathyroid hormone levels and urinary collagen cross-link excretion in postmenopausal women with spinal osteoporosis. Bone 2001;28:108-12. - PubMed
Zerbini 2017 {published data only}
    1. Zerbini CA Geusens P, Lespessailles E, Body JJ, Casado E, Stepan J, et al. Teriparatide compared with risedronate and the risk of clinical vertebral fractures: 2-year results of a randomized, double-dummy clinical trial. Arthritis and Rheumatology 2017;69(Suppl 10):Abstract Number: 320.
Zoehrer 2006 {published data only}
    1. Zoehrer R, Roschger P, Paschalis, EP, Hofstaetter JG, Durchschlag E, Fratzl P, et al. Effects of 3- and 5-year treatment with risedronate on bone mineralization density distribution in triple biopsies of the iliac crest in postmenopausal women. Journal of Bone and Mineral Research 2006;21(7):1106-12. - PubMed

References to studies awaiting assessment

Benhamou 2013 {published data only}
    1. Benhamou CL, Seefried L, Agodoa I, Vanden Bergh JP, Prince RL, Josse RG, et al. Treatment satisfaction in postmenopausal women suboptimally adherent to alendronate who transitioned to denosumab vs risedronate. Osteoporosis International 2013;24(1 Suppl 1):S159-60.
Bilek 2016 {published data only}
    1. Bilek LD, Waltman NL, Lappe JM, Kupzyk KA, Mack LR, Cullen DM, et al. Protocol for a randomized controlled trial to compare bone-loading exercises with risedronate for preventing bone loss in osteopenic postmenopausal women. BMC Womens Health 2016;16(1):59. - PMC - PubMed
Deng 2020 {published data only}
    1. Deng Y, Li L, Li C, Wang F, Qu Y. Efficacy of combined medication of risedronate sodium and selective estrogen receptor modulator on the postmenopausal osteoporosis. Pakistan Journal of Pharmaceutical Sciences 2000;33(1 (Special)):495-8. - PubMed
Felsenberg 2010 {published data only}
    1. Felsenberg D, Charpulat R, Cheung AM, LaRoche M, Morris E, Seeman E, et al. Longitudinal in vivo micro-CT assessment in osteopenic women demonstrated that risedronate reduced the deterioration of cortical bone. Bone 2010;47(Supplement 1):S35.
Hagino 2014 {published data only}
    1. Hagino H, Kishimoto H, Ohishi H, Horii S, Nakamura T. Efficacy, tolerability and safety of once-monthly administration of 75 mg risedronate in Japanese patients with involutional osteoporosis: A comparison with a 2.5 mg once-daily dosage regimen. Bone 2014;59:44-52. - PubMed
Ia Vilariño 2009 {published data only}
    1. Ia Vilariño S, Vilarino C, Schwartz A, Contreras Ortiz O, Dotto J. Comparison of different treatments on postmenopausal patients (POSTM). In: Maturitas. Vol. 63. 2009:S95.
Lim 2019 {published data only}
    1. Lim HH, Lim SJ, Park YS, Choi SH, Min YK, Yoon BK. Effects of risedronate versus menopausal hormone therapy on bone mineral density in postmenopausal Korean women with hip fracture: a randomized, open-label trial. Maturitas June 2019;124:143.
Matsuzaki 2012 {published data only}
    1. Matsuzaki K, Ito, Kaneko H, Kato M, Hikata T, Nango N, et al. Efficacy of osteoporotic agents in trabecular microstructure (SU0313). Journal of Bone and Mineral Research 2012;27(S1):S304.
NCT00345644 {published data only}
    1. NCT00345644. Risedronate in osteopenic postmenopausal women (OSMAUSE) [A non-invasive evaluation of bone microarchitecture modification in osteopenic postmenopausal women by 3D peripheral quantitative computed tomography: a 24 month, monocenter study comparing weekly oral risedronate 35 mg and placebo]. clinicaltrials.gov/ct2/show/NCT00345644 (first received 28 June 2006).
NCT00386360 {published data only}
    1. NCT00386360. Study of the effect of once a week risedronate on the microstructure of tibia and radius using a new scanning method [A non-invasive evaluation of bone microarchitecture modification in osteopenic postmenopausal women by 3D-Peripheral Quantitative Computed Tomography (3D-pQCT)]. clinicaltrials.gov/ct2/show/NCT00386360 (first received 11 January 2012).
NCT00402441 {published data only}
    1. NCT00402441. Risedronate in thepPrevention of osteoporosis in postmenopausal women [A one-year, multicenter, randomized, double-blind, placebo-controlled, parallel group study to determine the efficacy and safety of 35-mg risedronate administered once a week in the prevention of osteoporosis in postmenopausal women]. clinicaltrials.gov/ct2/show/NCT00402441 (first received 22 November 2006).
NCT00790101 {published data only}
    1. NCT00790101. Risedronate vs raloxifene in hormone replacement therapy discontinuation [An 18-month, multicenter, parallel-group study to determine the relative efficacy of risedronate versus raloxifene in subjects who have discontinued hormone replacement therapy (HRT) for early intervention in osteoporosis]. clinicaltrials.gov/ct2/show/NCT00790101 (first received 13 November 2008).
NCT01904110 {published data only}
    1. NCT01904110. To evaluate the efficacy and the safety of monthly versus weekly oral risedronate with vitamin D in compliance, improvement of vitamin D and BMD in Korean postmenopausal osteoporotic women [ For 12 months, the multi center, randomized, open-label comparative clinical study to evaluate the efficacy and the safety of monthly (RisenexM Group) versus weekly oral risedronate (Risenexsplus Group) with vitamin D in compliance, improvement of vitamin D and BMD in Korean postmenopausal osteoporotic women (Phase IV)]. clinicaltrials.gov/ct2/show/NCT01904110 (first received 22 July 2013).
Okamoto 2010 {published data only}
    1. Okamoto K, Inaba M, Furumitsu Y, Ban A, Mori N, Yukioka K, et al. Beneficial effect of risedronate on arterial thickening and stiffening with a reciprocal relationship to its effect on bone mass in female osteoporosis patients: a longitudinal study. Life Sciences 2010;87:686-91. - PubMed
Pastore 2014 {published data only}
    1. Pastore R, Bultrini A, DiGiacinto P, Cannuccia A, Frontoni S. Sequentialtherapy in severe osteoporosis. In: Osteoporosis International. Vol. 25. 2014:S254.
Seeman 2010 {published data only}
    1. Seeman E, Borah B, Chapurlat R, Felsenberg D, Darbie L, Rizzoli R. Risedronate reduces deterioration of cortical bone microarchitecture accompanying menopause. In: Journal of Bone and Mineral Research. Vol. 26. 2010:S32.
UMIN000010017 {published data only}
    1. UMIN000010017. Efficacy of bazedoxifene on vascular endothelial function in postmenopausal women with osteoporosis. ictrptest.azurewebsites.net/Trial2.aspx?TrialID=JPRN-UMIN000010017 (first received 19 Feburay 2013).
Yeter 2014 {published data only}
    1. Yeter A, Kavuncu V, Evcik FD, Demirdal US, Subasi V, Cakir T. Evalution the effects of raloxifene and risedronate on serum biochemical markers. Turkish Journal of Osteoporosis 2014;20:110-6.
Yildirim 2005 {published data only}
    1. Yildirim K, Gureser G, Karatay S, Melikoglu MA, Ugur M, Erdal A, et al. Comparison of the effects of alendronate, risedronate and calcitonin treatment in postmenopausal osteoporosis. Journal of Back and Musculoskeletal Rehabilitation 2005;18:85-9.

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References to other published versions of this review

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