Strontium ranelate: dose-dependent effects in established postmenopausal vertebral osteoporosis--a 2-year randomized placebo controlled trial

J Clin Endocrinol Metab. 2002 May;87(5):2060-6. doi: 10.1210/jcem.87.5.8507.


The aim of the strontium ranelate (SR) for treatment of osteoporosis (STRATOS) trial was to investigate the efficacy and safety of different doses of SR, a novel agent in the treatment of postmenopausal osteoporosis. A randomized, multicenter, double-blind, placebo-controlled trial was undertaken in 353 osteoporotic women with at least one previous vertebral fracture and a lumbar T-score <-2.4. Patients were randomized to receive placebo, 0.5 g, 1 g, or 2 g SR/d for 2 yr. The primary efficacy endpoint was lumbar bone mineral density (BMD), assessed by dual-energy x-ray absorptiometry. Secondary outcome measures included femoral BMD, incidence of new vertebral deformities, and biochemical markers of bone metabolism. Lumbar BMD, adjusted for bone strontium content, increased in a dose-dependent manner in the intention-to-treat population: mean annual slope increased from 1.4% with 0.5 g/d SR to 3.0% with 2 g/d SR, which was significantly higher than placebo (P < 0.01). There was a significant reduction in the number of patients experiencing new vertebral deformities in the second year of treatment with 2 g/d SR [relative risk 0.56; 95% confidence interval (0.35; 0.89)]. In the 2 g/d group, there was a significant increase in serum levels of bone alkaline phosphatase, whereas urinary excretion of cross-linked N-telopeptide, a marker of bone resorption, was lower with SR than with placebo. All tested doses were well tolerated; the 2 g/d dose was considered to offer the best combination of efficacy and safety. In conclusion, SR therapy increased vertebral BMD and reduced the incidence of vertebral fractures.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Alkaline Phosphatase / blood
  • Bone Density
  • Bone and Bones / enzymology
  • Collagen / urine
  • Collagen Type I
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Lumbar Vertebrae / drug effects*
  • Lumbar Vertebrae / metabolism
  • Middle Aged
  • Organometallic Compounds / administration & dosage*
  • Organometallic Compounds / adverse effects
  • Organometallic Compounds / therapeutic use
  • Osteoporosis, Postmenopausal / drug therapy*
  • Osteoporosis, Postmenopausal / metabolism
  • Peptides / urine
  • Placebos
  • Safety
  • Thiophenes / administration & dosage*
  • Thiophenes / adverse effects
  • Thiophenes / therapeutic use
  • Treatment Outcome


  • Collagen Type I
  • Organometallic Compounds
  • Peptides
  • Placebos
  • Thiophenes
  • collagen type I trimeric cross-linked peptide
  • strontium ranelate
  • Collagen
  • Alkaline Phosphatase