A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment
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
1 other identifier
interventional
781
15 countries
39
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2004
Longer than P75 for phase_4
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 29, 2007
CompletedFirst Posted
Study publicly available on registry
October 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
May 30, 2011
CompletedJuly 22, 2011
July 1, 2011
4.1 years
October 29, 2007
June 30, 2009
July 20, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months
Relative change percent(%) from baseline of MA17904 and BM16550 (NCT00048074) in mean lumbar spine (L2-L4) BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17940.Percent change=\[(measure at time t - measure at baseline)/measure at baseline\]\*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.
Baseline,12, 24 and 36 months
Secondary Outcomes (3)
Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months
Baseline,12, 24 and 36 months
Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months
Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550)
Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months
Baseline, 6 months
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).
Eligibility Criteria
You may qualify if:
- Successful completion of Bonviva study BM16550 (NCT00048074), with at least 75% compliance
- Ambulatory
You may not qualify if:
- Patients who completed the Bonviva study BM16550 (NCT00048074) \>3 months before the planned start date for this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Unknown Facility
Gainesville, Georgia, 30501, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Omaha, Nebraska, 68131, United States
Unknown Facility
Bismarck, North Dakota, 58501, United States
Unknown Facility
Fargo, North Dakota, 58103, United States
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Madison, Wisconsin, 53792, United States
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St Leonards, 2139, Australia
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Sydney, 3129, Australia
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Brussels, 1180, Belgium
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Liège, 4020, Belgium
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Pilsen, 305 99, Czechia
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Prague, 128 00, Czechia
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Aalborg, 9000, Denmark
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Aarhus, 8000, Denmark
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Ballerup Municipality, 2750, Denmark
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Copenhagen, 1399, Denmark
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Vejle, 7100, Denmark
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Lyon, 69000, France
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Orléans, 45032, France
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Berlin, 12200, Germany
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Essen, 45276, Germany
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Hamburg, 20354, Germany
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Budapest, 1036, Hungary
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Arenzano, 16011, Italy
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Siena, 53100, Italy
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Valeggio sul Mincio, 37067, Italy
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Mexico City, 11000, Mexico
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Monterrey, 64460, Mexico
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Haugesund, 5507, Norway
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Oslo, 0176, Norway
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Stavanger, 4010, Norway
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Grudziądz, 86-300, Poland
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Krakow, 30-510, Poland
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Krakow, 31-501, Poland
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Cape Town, 7500, South Africa
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Pretoria, South Africa
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Sommerset West, 7129, South Africa
Unknown Facility
Madrid, 28046, Spain
Unknown Facility
Aberdeen, AB25 2ZD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 29, 2007
First Posted
October 30, 2007
Study Start
October 1, 2004
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
July 22, 2011
Results First Posted
May 30, 2011
Record last verified: 2011-07