Conditions: Osteoporosis
Keywords: Menopausal Osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 870
Healthy volunteers: no

Brief summary:
A randomized, open label study to assess the safety and effectiveness of Denosumab, administered every 6 months and Actonel ® (Risedronate), administered monthly in post menopausal women transitioned from weekly or daily Alendronate therapy.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Actonel® intervention 2: Denosumab
Intervention descriptions: intervention 1: Oral Actonel® (Risedronate) in total a 150mg per month (one 75mg tablet to be taken on each of 2 consecutive days per month). intervention 2: Denosumab 60 mg, once every 6 months, Subcutaneous

Protocol document: