Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial.

in Annals of the Rheumatic Diseases (2013), 72(2), 179-86

BACKGROUND: Strontium ranelate is currently used for osteoporosis. The international, double-blind, randomised, placebo-controlled Strontium ranelate Efficacy in Knee OsteoarthrItis triAl evaluated its ... [more ▼]

BACKGROUND: Strontium ranelate is currently used for osteoporosis. The international, double-blind, randomised, placebo-controlled Strontium ranelate Efficacy in Knee OsteoarthrItis triAl evaluated its effect on radiological progression of knee osteoarthritis. METHODS: Patients with knee osteoarthritis (Kellgren and Lawrence grade 2 or 3, and joint space width (JSW) 2.5-5 mm) were randomly allocated to strontium ranelate 1 g/day (n=558), 2 g/day (n=566) or placebo (n=559). The primary endpoint was radiographical change in JSW (medial tibiofemoral compartment) over 3 years versus placebo. Secondary endpoints included radiological progression, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, and knee pain. The trial is registered (ISRCTN41323372). RESULTS: The intention-to-treat population included 1371 patients. Treatment with strontium ranelate was associated with smaller degradations in JSW than placebo (1 g/day: -0.23 (SD 0.56) mm; 2 g/day: -0.27 (SD 0.63) mm; placebo: -0.37 (SD 0.59) mm); treatment-placebo differences were 0.14 (SE 0.04), 95% CI 0.05 to 0.23, p<0.001 for 1 g/day and 0.10 (SE 0.04), 95% CI 0.02 to 0.19, p=0.018 for 2 g/day. Fewer radiological progressors were observed with strontium ranelate (p<0.001 and p=0.012 for 1 and 2 g/day). There were greater reductions in total WOMAC score (p=0.045), pain subscore (p=0.028), physical function subscore (p=0.099) and knee pain (p=0.065) with strontium ranelate 2 g/day. Strontium ranelate was well tolerated. CONCLUSIONS: Treatment with strontium ranelate 1 and 2 g/day is associated with a significant effect on structure in patients with knee osteoarthritis, and a beneficial effect on symptoms for strontium ranelate 2 g/day. [less ▲]

Structure modifying effects of strontium ranelate in knee osteoarthritis

in Osteoporosis International (2012, March), 23(S2), 58-59

Five years of denosumab exposure in women with postmenopausal osteoporosis: Results from the first two years of the FREEDOM extension.

in Journal of Bone and Mineral Research (2012), 27(3), 694-701

The 3-year FREEDOM trial assessed the efficacy and safety of 60 mg denosumab every 6 months for treatment of postmenopausal women with osteoporosis. Participants who completed FREEDOM were eligible to ... [more ▼]

The 3-year FREEDOM trial assessed the efficacy and safety of 60 mg denosumab every 6 months for treatment of postmenopausal women with osteoporosis. Participants who completed FREEDOM were eligible to enter an extension to continue the evaluation of denosumab efficacy and safety for up to 10 years. For the extension results presented here, women from the FREEDOM denosumab group had 2 more years of denosumab treatment (long-term group) and those from the FREEDOM placebo group had 2 years of denosumab exposure (cross-over group). We report results for bone turnover markers (BTMs), bone mineral density (BMD), fractures rates, and safety. A total of 4550 women enrolled in the extension (2343 long-term; 2207 cross-over). Reductions in BTMs were maintained (long-term group) or occurred rapidly (cross-over group) following denosumab administration. In the long-term group, lumbar spine and total hip BMD increased further, resulting in 5-year gains of 13.7% and 7.0%, respectively. In the cross-over group, BMD increased at the lumbar spine (7.7%) and total hip (4.0%) during the 2-year denosumab treatment. Yearly fracture incidences for both groups were below rates observed in the FREEDOM placebo group and below rates projected for a "virtual untreated twin" cohort. Adverse events did not increase with long-term denosumab administration. Two adverse events in the cross-over group were adjudicated as consistent with osteonecrosis of the jaw (ONJ). Five-year denosumab treatment of women with postmenopausal osteoporosis maintained BTM reduction and increased BMD, and was associated with low fracture rates and a favorable risk/benefit profile. (c) 2011 American Society for Bone and Mineral Research. [less ▲]

Strontium ranelate in knee osteoarthritis trial (SEKOIA) : a structural and symptomatic efficacy

in Arthritis and Rheumatism (2012), 64(S10), 681

Treatment of postmenopausal women with osteoporosis for six years with denosumab : three-year results from the freedom extension

in Annals of the Rheumatic Diseases (2012), 71(3), 588

Five-year Denosumab treatment of postmenopausal women with osteoporosis: results from the first two years of the freedom trial extension

in Osteoporosis International (2011, March), 22(Suppl.1), 107-108

A phase 3 study of the efficacy and safety of Denosumab in men with low bone mineral density : design of the ADAMO

in Journal of Bone and Mineral Research (2011), 26(S1), 511

Traitement durant cinq ans par denosumab (DMAb) chez des femmes ménopausées ostéoporotiques : résultats d'efficacité des deux premières années de l'extension de l'essai FREEDOM

in Revue du Rhumatisme (2011), 78(S5), 214

Extended safety observations from denosumab administration in postmenopausal women from FREEDOM and FREEDOM extension trials

in Arthritis and Rheumatism (2011), 63(S10), 431-432

Long-term denosuamab treatment in postmenopausal women with osteoporosis : results from the first two years of the FREEDOM trial extension

in Osteoporosis International (2011), 22(S4), 527-528