A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-Menopausal Osteoporosis
Intervention: ibandronate [Bonviva/Boniva] (Drug); ibandronate [Bonviva/Boniva] (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s): Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
Summary
This 2-arm study was designed to assess the long-term safety and tolerability of intravenous
(IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had
previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received
Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received
daily supplementation with vitamin D and calcium. The anticipated time on study treatment
was 2+ years, and the target sample size was 500+ individuals.
Clinical Details
Official title: Open Label, Parallel Group, Multicenter Study of Two Intravenous (IV) Ibandronate Dose Regimens (2 mg Every 2 Months and 3 mg Every 3 Months) in Women With Postmenopausal Osteoporosis Who Completed Trial BM16550
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months
Secondary outcome: Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 MonthsRelative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Successful completion of Bonviva study BM16550 (NCT00048074), with at least 75%
compliance
- Ambulatory
Exclusion Criteria:
- Patients who completed the Bonviva study BM16550 (NCT00048074) >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
Locations and Contacts
St. Leonards 2139, Australia
Sydney 3129, Australia
Bruxelles 1180, Belgium
Liege 4020, Belgium
Plzen 305 99, Czech Republic
Praha 128 00, Czech Republic
Aalborg 9000, Denmark
Ballerup 2750, Denmark
København 1399, Denmark
Vejle 7100, Denmark
Århus 8000, Denmark
Lyon 69000, France
Orleans 45032, France
Berlin 12200, Germany
Essen 45276, Germany
Hamburg 20354, Germany
Budapest 1036, Hungary
Arenzano 16011, Italy
Siena 53100, Italy
Valeggio Sul Mincio 37067, Italy
Mexico City 11000, Mexico
Monterrey 64460, Mexico
Haugesund 5507, Norway
Oslo 0176, Norway
Stavanger 4010, Norway
Grudziadz 86-300, Poland
Krakow 31-501, Poland
Krakow 30-510, Poland
Cape Town 7500, South Africa
Pretoria, South Africa
Sommerset West 7129, South Africa
Madrid 28046, Spain
Aberdeen AB25 2ZD, United Kingdom
Gainesville, Georgia 30501, United States
St Louis, Missouri 63110, United States
Omaha, Nebraska 68131, United States
Bismarck, North Dakota 58501, United States
Fargo, North Dakota 58103, United States
Madison, Wisconsin 53792, United States
Additional Information
Clinical Study Report Synopsis
Starting date: October 2004
Last updated: July 20, 2011
|