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Strontium Ranelate: Dose-Dependent Effects in Established Postmenopausal Vertebral Osteoporosis—A 2-Year Randomized Placebo Controlled Trial

Hôpital Edouard Herriot (P.J.M., P.D.D.), 69437 Lyon, France; Cantonal Hospital (D.O.S.), 1211 Geneva 14, Switzerland; Centre Hospitalo-Universitaire (J.L.S.), 80030 Amiens, France; University of Florence (M.L.B.), 50139 Florence, Italy; University of Rome (C.A.), 00161 Rome, Italy; Health Center (R.L.), 04-736 Warsaw, Poland; Hillerød Hospital (S.P.-N.), 3400 Hillerød, Denmark; Hôpital Lariboisière (M.C.d.V.), 75475 Paris, France; Hospital Candelaria (A.R.), 38010 Santa Cruz de Tenerife, Spain; and Centre Hospitalo-Universitaire (J.Y.R.), 4020 Liège, Belgium

Address all correspondence and requests for reprints to: Pierre J. Meunier, M.D., Hôpital Edouard Herriot, 69437 Lyon Cedex 03, France. E-mail: . Meunier{at}lyon151.inserm.fr

Abstract

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.

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