Trial information
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment
Status: Completed
Protocol number: MA17904
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: Open label, parallel group, multicenter study of two IV ibandronate dose regimens (2 mg every 2 months and 3 mg every 3 months) in women with postmenopausal osteoporosis who completed trial BM16550
Brief summary: This 2 arm study will assess the long-term safety and tolerability of intravenous treatment with 2mg or 3mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16550 (DIVA study). Patients will receive Bonviva either 2mg iv every 2 months, or 3mg iv every 3 months 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 650.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; 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 BM16550, with at least 75% compliance;
- ambulatory.
Exclusion criteria:
- patients who completed the Bonviva study BM16550 >3 months before the planned start date for this study;
- malignant disease diagnosed since inclusion into previous study;
- treatment with drugs affecting bone metabolism since inclusion into previous study.
Gender: Females
Age limits: Min: N/A (No limit) Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: October, 2004
Trial registration date: 06/24/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
Belgium
Czech Republic
Denmark
- Aalborg
- Århus
- Ballerup
- København
- Vejle
France
Germany
Hungary
Italy
- Arenzano
- Siena
- Valeggio Sul Mincio
Mexico
Norway
Poland
South Africa
- Cape Town
- Pretoria
- Sommerset West
Spain
United Kingdom
United States
- Gainesville, GA
- St Louis, MO
- Omaha, NE
- Bismarck, ND
- Fargo, ND
- Madison, WI
