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Trial information
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis
Status: Completed
Protocol number: MM17385
Sponsor: Hoffman-La Roche
Company division: Pharmaceutical
Official Scientific Title: Randomized, double-blind, double-dummy, parallel group, multicenter study to compare the efficacy and safety of once-monthly oral administration of 150mg ibandronate with once-weekly oral administration of 70mg alendronate in postmenopausal osteoporosis - Non-inferiority trial.
Brief summary: This study will evaluate the safety and efficacy of oral Bonviva and that of oral alendronate in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.
Target sample size is 1786.
Study phase: III
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. Efficacy: Relative change from baseline in total hip bone mineral density (BMD) at 12 months
Key secondary outcomes: 1. Efficacy: Relative and absolute change in mean lumbar spine BMD and in trochanter, absolute change in total hip BMD, percent of responders, relative and absolute change from baseline serum CTX
Safety: Adverse events, laboratory blood tests
Inclusion criteria: - women 55-84 years of age;
- postmenopausal for >= 5 years;
- ambulatory.
Exclusion criteria: - inability to stand or sit upright for 60 minutes;
- malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);
- breast cancer within the previous 20 years;
- allergy to bisphosphonates;
- previous treatment with an intravenous bisphosphonate at any time;
- previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within the last year, >3 months of treatment within the last 2 years.
Gender: Females
Age limits: Min: 55 Years Max: 84 Years
Accepts healthy volunteers: No
Trial registration date: 06/24/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:Argentina Belgium Brazil - Brasilia
- Sao Paulo
- Vitoria
Denmark France Germany Hungary - Balatonfuered
- Budapest
- Gyor
- Zalaegerszeg
Norway Poland Russian Federation South Africa - Johannesburg
- Parow
- Sommerset West
Spain United Kingdom United States - Oakland, CA
- San Diego , CA
- Upland, CA
- Boulder, CO
- Lakewood, CO
- Longmont, CO
- Boca Raton, FL
- Clearwater, FL
- Stuart, FL
- West Palm Beach, FL
- Gainesville, GA
- Boise, ID
- Springfield, IL
- Indianapolis , IN
- Bangor, ME
- Bethesda, MD
- Hagerstown, MD
- Billings, MT
- Lincoln, NE
- Omaha, NE
- Albuquerque, NM
- West Haverstraw, NY
- Fargo, ND
- Cincinnati, OH
- Medford, OR
- Portland, OR
- Wyomissing, PA
- Amarillo, TX
- San Antonio, TX
- Madison, WI
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