Trial information
A Study of Bonviva (Ibandronic Acid) in Women With Post-Menopausal Osteoporosis
Status: Completed
Protocol number: ML18373
Sponsor: Roche Products Ltd.
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study to assess the persistence on treatment treatment persistence in women with post-menopausal osteoporosis receiving once monthly Bonviva , with either a patient support program or bone turnover marker monitoring
Brief summary: This study will evaluate persistence on once-monthly oral Bonviva in women with post-menopausal osteoporosis. Patients will either participate in a patient support program, or will undergo biochemical monitoring of markers of bone turnover on 2 occasions, and have the results fed back to them.. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.
Target sample size is 690.
Study phase: III
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety study
Condition: Post-Menopausal Osteoporosis
Intervention type: Drug
Intervention name: ibandronate[Bonviva/Boniva]
Primary outcome: 1. Persistence (time on therapy) measured by number of months of study drug therapy
Key secondary outcomes: 1. Reason for discontinuation. Adverse events
Inclusion criteria:
- women with post-menopausal osteoporosis.
Exclusion criteria:
- previous or current treatment with a bisphosphonate;
- hypersensitivity to bisphosphonates;
- bone fracture within 6 months of study entry;
- hormone replacement therapy within 6 months of study entry;
- inability to stand or sit upright for >=60 minutes;
- administration of any investigational drug within 30 days preceding the first dose of study drug;
- esophageal abnormality.
Gender: Females
Age limits: Min: N/A (No limit) Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 08/30/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
United Kingdom
