A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Active, not recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
Summary
This 2 arm study will assess the long-term safety and tolerability of intravenous treatment
with 2mg or 3mg Bonviva in women with post-menopausal osteoporosis who have previously
completed Bonviva study BM16550 (DIVA study). Patients will receive Bonviva either 2mg iv
every 2 months, or 3mg iv every 3 months Patients will also receive daily supplementation
with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the
target sample size is 500+ individuals.
Clinical Details
Official title: Open Label, Parallel Group, Multicenter Study of Two 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: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Relative change in mean lumbar spine bone mineral density (BMD)
Secondary outcome: Relative change in mean total hip BMDRelative change in serum CTX AEs and laboratory parameters
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- successful completion of Bonviva study BM16550, with at least 75% compliance;
- ambulatory.
Exclusion Criteria:
- patients who completed the Bonviva study BM16550 >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
PRAHA 128 00, Czech Republic
PLZEN 305 99, Czech Republic
BALLERUP 2750, Denmark
VEJLE 7100, Denmark
AALBORG 9000, Denmark
KØBENHAVN 1399, Denmark
ÅRHUS 8000, Denmark
LYON 69000, France
ORLEANS 45032, France
BERLIN 12200, Germany
HAMBURG 20354, Germany
ESSEN 45276, Germany
HAMBURG 20246, Germany
BUDAPEST 1036, Hungary
SIENA 53100, Italy
VALEGGIO SUL MINCIO 37067, Italy
ARENZANO 16011, Italy
MEXICO CITY 11000, Mexico
MONTERREY 64460, Mexico
OSLO 0176, Norway
STAVANGER 4010, Norway
HAUGESUND 5507, Norway
KRAKOW 31-501, Poland
GRUDZIADZ 86-300, Poland
KRAKOW 30-510, Poland
SOMMERSET WEST 7129, South Africa
CAPE TOWN 7500, South Africa
PRETORIA, 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
Starting date: October 2004
Ending date: July 2008
Last updated: June 17, 2008
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