Trial information
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva
Status: Completed
Protocol number: MA17903
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: Double-blind, partially randomized, parallel group, multicenter study to assess the efficacy and safety of 100 mg and 150 mg monthly oral ibandronate in women with postmenopausal osteoporosis having completed the phase III oral ibandronate trial BM16549
Brief summary: This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. 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.
Target sample size is 719.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
Condition: Post-Menopausal Osteoporosis
Intervention type: Drug
Intervention name: ibandronate [Bonviva/Boniva]
Primary outcome: 1. Relative change in mean lumbar spine bone mineral density (BMD) Time frame: 12, 24 and 36 months
Key secondary outcomes: 1. Relative change in mean total hip BMD Time frame: 12, 24 and 36 months
2. Relative change in serum CTX Time frame: Trough and peak suppression
3. AEs and laboratory parameters Time frame: Throughout study
Inclusion criteria:
- successful completion of Bonviva study BM16549, with at least 75% compliance;
- ambulatory.
Exclusion criteria:
- malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed);
- breast cancer diagnosed within the previous 22 years.
Gender: Females
Age limits: Min: N/A (No limit) Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 06/24/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
Brazil
Czech Republic
Denmark
France
Germany
Hungary
- Balatonfuered
- Budapest
- Kiskunhalas
- Zalaegerszeg
Italy
Mexico
Norway
Poland
Spain
United Kingdom
United States
- Loma Linda, CA
- Lakewood, CO
- Omaha, NE
- Livingston, NJ
- Portland, OR
