Efficacy of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and osteoporotic post-menopausal women

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2010
INTERVENTION: One daily administration of strontium ranelate 2 g or placebo during 24 weeks. There is no visit after the last intake at week‐24. CONDITION: Radius fracture, Osteoporosis ; Musculoskeletal Diseases ; Osteoporosis with pathological fracture PRIMARY OUTCOME: Time to radiological healing. Radiological evaluation will be performed at baseline, at week 4, 6, 7, 8, 9, 10, 12, 14 and at the last study visit. No radiography will be performed once radiological healing is complete, except at the last study visit. SECONDARY OUTCOME: 1. Other radiological evaluations, performed at baseline, at week 4, 6, 7, 8, 9, 10, 12, 14 and at the last study visit. No radiography will be performed once radiological healing is complete, except at the last study visit. ; 2. Clinical evaluation (including mobility, quality of life, etc), performed at least once every 4 weeks from baseline to week 18 and at the last study visit; 3. Safety evaluation, performed at least once every 4 weeks from baseline to week 18 and at the last study visit INCLUSION CRITERIA: 1. Osteoporotic men and osteoporotic post‐menopausal women 2. Aged superior or equal to 50 years 3. Patient with a fracture of the distal radius (Colles' fracture)
Epistemonikos ID: 3a6a9f5a2628f5a7e6e6e1acef2f217cf1994baa
First added on: Aug 22, 2024