Home » Clinical Trials » Medical Areas
Therapeutic Areas: Obstetrics/Gynecology | Musculoskeletal
Disease Category: Post-Menopausal Osteoporosis
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 Design / Study Details:
- Purpose: Treatment
- Allocation: Randomized
- Masking: Double Blind
- Control: Active
- Assignment: Parallel
- Endpoints: Safety/Efficacy
Study Type:
Interventional
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: 12/08/2008
Link To Trial Results
Research Site:
Located In:
Upland CA 91786
Phone: 973-235-5000 or 800-526-6367
View Google Map
DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the
clinical trials industry. The information provided in this service is designed
to help patients find clinical trials that may be of interest to them, and to
help patients contact the centers conducting the research. CenterWatch is
neither promoting this research nor involved in conducting any of these
trials.
