Trial information
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis
Status: Completed
Protocol number: MA17844
Sponsor: F Hoffman-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label, multi-center and multinational study to investigate patient preference on dosing in women with postmenopausal osteoporosis treated with once-monthly ibandronate and once-weekly alendronate. A six-month, two-sequence, and two-period crossover study.
Brief summary: This study will evaluate patient-reported preference of either oral Bonviva or a comparator drug in women with post-menopausal osteoporosis. The anticipated time of study treatment is 3-6 months, and the target sample size is 100-500 individuals.
Target sample size is 338.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Crossover; Safety/Efficacy study
Condition: Post-Menopausal Osteoporosis
Intervention type: Drug
Intervention name: ibandronate[Bonviva/Boniva]
Primary outcome: 1. Efficacy: Proportion (%) of patients preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate
Key secondary outcomes: 1. Proportion (%) of patients perceiving the once-monthly dosing of ibandronate to be more convenient versus once-weekly dosing of alendronate. Explore characteristics of preferred medication.
Safety: Adverse events and laboratory tests
Inclusion criteria:
- ambulatory women;
- diagnosis of post-menopausal osteoporosis;
- women who have never received bisphosphonate therapy, or who have discontinued daily bisphosphonates at least 3 months prior to study entry.
Exclusion criteria:
- inability to stand or sit in the upright position for >=60 minutes;
- allergy to bisphosphonates;
- previous or current treatment with weekly or monthly bisphosphonates, or daily bisphosphonates for the last 3 months prior to study entry.
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:
France
- Amiens
- Angers
- Clamart
- Clichy
- Issy Les Moulineaux
- Lille
- Limoges
- Nice
- Orleans
- Paris
- Strasbourg
- Toulouse
- Vandoeuvre-Les-Nancy
- Versailles
Germany
- Bad Pyrmont
- Berlin
- Braunfels
- Frankfurt Am Main
- Marburg
- Stockach
- Wolgast
United States
- Montgomery, AL
- La Jolla, CA
- San Diego , CA
- Norwalk, CT
- Cocoa Beach, FL
- Waterloo, IA
- Kenner, LA
- Baltimore, MD
- Fall River, MA
- Olive Branch, MS
- St Louis, MO
- Las Vegas, NV
- Dover, NH
- Albuquerque, NM
- New York, NY
- Cleveland, OH
- Philadelphia, PA
- Spartanburg, SC
- Houston, TX
- Norfolk , VA
- Seattle, WA
