title: Clinical effects of strontium ranelate in women with postmenopausal osteoporosis.
abstract: Postmenopausal osteoporosis has long-term physical, psychological, and social consequences with a major impact on patients' daily life. Treatment for such a chronic disease needs to be clinically effective and well tolerated, and should ultimately result in a beneficial effect on quality of life. The antifracture efficacy of strontium ranelate, 2 g/day orally, an agent that appears to have dissociation effects on resorption and formation, has been assessed in two large, randomized, double-blind, placebo-controlled clinical studies: the Spinal Osteoporosis Therapeutic Intervention (SOTI) trial and the TReatment Of Peripheral Osteoporosis Study (TROPOS), including more than 6,700 postmenopausal women. Pending the results of TROPOS, a 3-year analysis of SOTI results shows that strontium ranelate significantly reduces new vertebral and clinical vertebral fracture incidence in postmenopausal osteoporotic women. This significant reduction in the risk of clinical and new vertebral fractures has been demonstrated as early as after 1 year of treatment (RR = 0.48, p = 0.003; and RR = 0.51, p < 0.001, respectively) and is maintained over 3 years (RR = 0.62, p < 0.001; and RR = 0.59, p < 0.001, respectively). This is accompanied by decreased back pain and body height loss in the strontium ranelate group compared with the placebo group. As strontium ranelate appears to improve clinical signs and is, furthermore, well tolerated especially in the upper gastrointestinal region, this treatment is expected to result in an improved health-related quality of life (HRQoL). Strontium ranelate thus offers significant clinical benefits in terms of efficacy, tolerability, and ease of administration in the treatment of postmenopausal women with vertebral osteoporotic fractures.
authors.affiliation: INSERM Unit 403, Hôpital E. Herriot, 5 place Arsonval, F69437 Lyon Cedex 03, France. delmas@lyon.inserm.fr
authors.forename: Pierre D
authors.initials: PD
authors.lastname: Delmas
mesh_terms: D000368:Aged; D017326:Clinical Trials, Phase III as Topic; D003967:Diarrhea / Q000139:chemically induced; D005260:Female; D050723:Fractures, Bone / Q000453:epidemiology / Q000517:prevention & control* / Q000523:psychology; D005756:Gastritis / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D009942:Organometallic Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D012306:Risk; D016103:Spinal Fractures / Q000453:epidemiology / Q000517:prevention & control; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D014475:Uncoupling Agents / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D009942:Organometallic Compounds; D013876:Thiophenes; D014475:Uncoupling Agents; C081587:strontium ranelate