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. 2018 Aug 7;13(1):85.
doi: 10.1007/s11657-018-0491-z.

Persistence at 24 months with denosumab among postmenopausal women with osteoporosis: results of a prospective cohort study

Stuart L Silverman  1 , E Siris  2 , D Belazi  3 , C Recknor  4 , A Papaioannou  5 , J P Brown  6 , D T Gold  7 , E M Lewiecki  8 , G Quinn  9 , A Balasubramanian  10 , S Yue  10 , B Stolshek  10 , D L Kendler  11
Affiliations
Free PMC article

Persistence at 24 months with denosumab among postmenopausal women with osteoporosis: results of a prospective cohort study

Stuart L Silverman et al. Arch Osteoporos. .
Free PMC article

Abstract

Persistence with prescribed medications for chronic diseases is important; however, persistence with osteoporosis treatments is historically poor. In this prospective cohort study of postmenopausal women treated for osteoporosis in real-world clinical practice settings in the USA and Canada, 24-month persistence with denosumab was 58%.

Purpose: Patients who persist with their prescribed osteoporosis treatment have increased bone mineral density (BMD) and reduced risk of fracture. Twelve-month persistence with denosumab in routine clinical practice is as high as 95%, but there are limited data on longer-term persistence with denosumab in this setting.

Methods: This single-arm, prospective, cohort study evaluated 24-month persistence with denosumab administered every 6 months in postmenopausal women receiving treatment for osteoporosis in real-world clinical practice in the USA and Canada. Endpoints and analyses included the percentage of patients who persist with denosumab at 24 months (greater than or equal to four injections with a gap between injections of no more than 6 months plus 8 weeks), the total number of injections received by each patient, changes in BMD in persistent patients, and the incidence of serious adverse events (SAEs) and fractures.

Results: Among 935 enrolled patients, 24-month persistence was 58% (50% in US patients and 75% in Canadian patients). A majority of patients received at least four injections over the observation period (62% of US patients and 81% of Canadian patients). Among patients who were persistent at 24 months and who had a baseline, 12-month, and 24-month DXA scan, mean BMD increased from baseline to 24 months by 7.8% at the lumbar spine and 2.1% at the femoral neck. SAEs and fractures were reported for 122 (13.0%) patients and 54 (5.8%) patients, respectively.

Conclusions: Persistence with denosumab for 24 months yields improvement in BMD among postmenopausal women with osteoporosis treated in routine clinical practice in the USA and Canada.

Keywords: Bone mineral density; Clinical practice; Cohort study; Denosumab; Osteoporosis; Persistence.

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Conflict of interest statement

S.L. Silverman is a speaker for Lilly, Amgen, and Radius; is a consultant for Amgen; has received research grants from Lilly and Amgen; and has participated in advisory boards for Amgen and Radius. E. Siris was a consultant for Amgen, Merck, and Radius. D. Belazi has no conflict of interest or disclosures. C. Recknor has received research support from Amgen and Eli Lilly. A. Papaioannou has received consulting fees and grants from Amgen. J.P. Brown has received grants/research support from Amgen and Eli Lilly; has received consulting fees from Amgen, Eli Lilly, and Merck; and speakers’ bureau honorarium from Amgen and Eli Lilly. D.T. Gold has received consulting fees from Amgen, Eli Lilly, and Radius. E.M. Lewiecki has received grants/research support from Amgen and consulting fees from Amgen and Radius. G. Quinn has received consulting fees from Amgen. A. Balasubramanian, S. Yue, and B. Stolshek are employees and shareholders of Amgen Inc. D.L. Kendler has received research grants from Amgen, AstraZeneca, and Eli Lilly; is a consultant for Amgen, Pfizer, and Eli Lilly; and has received speakers’ honoraria from Amgen and Eli Lilly.

Figures

Fig. 1
Fig. 1
Flow of patients through the study. a Patients included in the analysis of persistence. Patient enrollment was completed on April 5, 2012, and the end of follow-up was on April 14, 2014. a Study completion data were missing for eight patients. b Provision of “other reasons” for discontinuation from the study was not required per protocol. b Patients included in the analysis of BMD. DXA scans were taken within prespecified visit windows (baseline: up to 1 year prior or up to 3 months after baseline injection; postbaseline: DXA nearest to the dose date plus 366 days)
Fig. 2
Fig. 2
Persistence with denosumab at 12 and 24 months. a Percentage of patients who were persistent with denosumab at 12 and 24 months. The primary analysis set included patients who received at least two denosumab injections (12-month persistence) or four denosumab injections (24-month persistence), with an injection interval of no longer than 6 months plus 8 weeks. b Sensitivity analysis of 24-month persistence. Sensitivity analyses were done to evaluate whether persistence is affected by varying the time interval between injections—6 months plus 4 weeks, 6 months plus 6 weeks, or 6 months plus 12 weeks. Error bars represent 95% confidence intervals
Fig. 3
Fig. 3
BMD at the lumbar spine and femoral neck in patients who were persistent at 24 months and who had a baseline, 12-month, and 24-month DXA scan. a Mean percentage change in BMD from baseline. Error bars represent 95% confidence intervals; 77 and 72 patients were evaluable at the lumbar spine and femoral neck, respectively. b Proportion of patients with ≥ 3% improvement in BMD at 12 and 24 months; 77 and 72 patients were evaluable at the lumbar spine and femoral neck, respectively. c Proportion of patients with T-scores ≤ − 2.5 at baseline, 12 months, and 24 months; 79 and 74 patients were evaluable at the lumbar spine and femoral neck, respectively. BMD bone mineral density; DXA dual-energy x-ray absorptiometry
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