Trial information
A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.
Status: Completed
Protocol number: ML19814
Sponsor: Productos Roche Chile
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study to investigate the impact of Bone Marker feedback (bio-feedback) on adherence to monthly Bonviva in women with post-menopausal osteoporosis.
Brief summary: This study will assess the impact of bone-marker feedback (bio-feedback) using resorption bone markers and communication of the results at 3 months, on adherence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. The study will also compare the effect of bio-feedback and no bio-feedback on efficacy and patient satisfaction. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals. Target sample size is 784.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Post-Menopausal Osteoporosis
Intervention type: Drug
Intervention name: ibandronate[Bonviva/Boniva]
Primary outcome: 1. Comparison of the proportion of patients with >=83% adherence at 6 months (ie 5 of 6 possible administrations) to Bonviva in the feedback vs no feedback group.
Key secondary outcomes: 1. Compliance: Patient satisfaction, using OPSAT-Q and OPPS; Efficacy: suppression of bone markers. Safety: AEs, fractures.
Inclusion criteria:
- ambulatory post-menopausal women with osteoporosis or osteopenia;
- eligible for bisphosphonate treatment;
- naive to bisphosphonate therapy, lapsed users (last bisphosphonate intake >6 months ago) or current users.
Exclusion criteria:
- inability to stand or sit in an upright position for at least 60 minutes;
- inability to swallow a tablet whole;
- hypersensitivity to bisphosphonates;
- history of major upper gastrointestinal disease.
Gender: Females
Age limits: Min: N/A (No limit) Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/04/2006
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Chile
Mexico
- Guadalajara
- Guadalajara, Jalisco
- Hermosillo
- Mexico City
- Monterrey
- Obregon
- Pachuca
- Puebla
- Queretaro
- Tijuana
