Conditions: Osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 515
Healthy volunteers: no

Brief summary:
A study designed to see if the study drug will increase blood levels of vitamin D, bone mineral density (BMD), improve biochemical markers of bone turnover, and reduce the number of falls as compared to women receiving standard care for osteoporosis.

Detailed description:

Arms:
arm 1: alendronate sodium (+) cholecalciferol arm 2: Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.

Interventions: intervention 1: FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol) intervention 2: Calcium Supplement 500 mg intervention 3: Referred-Care Model
Intervention descriptions: intervention 1: FOSAVANCE 5600 international units (IU)(Alendronate Sodium 70 mg/Vitamin D 5600 IU) combination tablet once weekly for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52). intervention 2: Calcium supplied locally by the investigator (containing 500 mg

calcium supplement) daily for 52 weeks (unless the patient's dietary intake of

calcium exceeds 1000 mg per day). intervention 3: Usual treatment for osteoporosis chosen and prescribed by patients' own physicians for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).

Protocol document: