Conditions: Post Menopausal Osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1609
Healthy volunteers: no

Brief summary:
This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Detailed description:

Arms:
arm 1: Participants will receive 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly. Participants will also receive calcium 500 mg /day and vitamin D 400 international units (IU)/day . arm 2: Participants will receive 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day. arm 3: Participants will receive 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day arm 4: Participants will receive 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day

Interventions: intervention 1: Ibandronate [Bonviva/Boniva] intervention 2: Ibandronate [Bonviva/Boniva] intervention 3: Ibandronate [Bonviva/Boniva] intervention 4: Ibandronate [Bonviva/Boniva] intervention 5: Calcium intervention 6: Vitamin D
Intervention descriptions: intervention 1: 2.5mg po daily intervention 2: 100mg po monthly on a single day intervention 3: 100mg po monthly over 2 consecutive days intervention 4: 150mg po monthly intervention 5: 500 mg/day intervention 6: 400 IU/day

Protocol document: