Conditions: Osteoporosis Postmenopausal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 343
Healthy volunteers: no

Brief summary:
To demonstrate the efficacy/safety of Fosamax Plus D

Detailed description:

Arms:
arm 1: Alendronate sodium/Cholecalciferol arm 2: Alendronate sodium

Interventions: intervention 1: alendronate sodium (+) cholecalciferol intervention 2: Comparator: Alendronate sodium (Fosamax) intervention 3: Comparator: Calcium
Intervention descriptions: intervention 1: Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks intervention 2: Alendronate sodium; tablet, once weekly, for 16 weeks intervention 3: 500 mg oral tablet calcium once daily, for 16 weeks

Protocol document: