Conditions: Osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1262
Healthy volunteers: no

Brief summary:
Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)

Detailed description:

Arms:
arm 1: Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months). arm 2: Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months). arm 3: Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).

Interventions: intervention 1: Denosumab intervention 2: Placebo intervention 3: Alendronate sodium hydrate
Intervention descriptions: intervention 1: Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months). intervention 2: Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months). intervention 3: Oral tablet once a week for 24 months

Protocol document: