A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva
Double-blind, Partially Randomized, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis Having Completed the Phase III Oral Ibandronate Trial BM16549
1 other identifier
interventional
719
14 countries
31
Brief Summary
This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2004
Longer than P75 for phase_4
31 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
First Submitted
Initial submission to the registry
April 19, 2004
CompletedFirst Posted
Study publicly available on registry
April 21, 2004
CompletedStudy Start
First participant enrolled
May 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
July 21, 2009
CompletedJuly 14, 2017
July 1, 2017
3.5 years
April 19, 2004
December 22, 2008
July 13, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD
Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm\^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]).
Baseline and Months 12, 24 and 36
Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)
BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae \[L2-L4\] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]).
Baseline and Months 12, 24 and 36
Secondary Outcomes (4)
Absolute Change From Baseline in Mean Total Hip BMD
Baseline and 12, 24 and 36 months
Relative Percent Change From Baseline in Mean Total Hip BMD
Baseline, 12, 24 and 36 months
Absolute Change From Baseline of Trough Serum CTX
Baseline, 6, 12, 24 and 36 months
Relative Percent Change From Baseline of Trough Serum CTX
Baseline, 6,12, 24 and 36 months
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- successful completion of Bonviva study BM16549, with at least 75% compliance;
- ambulatory.
You may not qualify if:
- malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed);
- breast cancer diagnosed within the previous 22 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Unknown Facility
Loma Linda, California, 92357, United States
Unknown Facility
Lakewood, Colorado, 80260, United States
Unknown Facility
Omaha, Nebraska, 68131, United States
Unknown Facility
Livingston, New Jersey, 07039, United States
Unknown Facility
Portland, Oregon, 97213, United States
Unknown Facility
Liège, 4020, Belgium
Unknown Facility
Merksem, 2170, Belgium
Unknown Facility
São Paulo, 04026-000, Brazil
Unknown Facility
Pilsen, 305 99, Czechia
Unknown Facility
Prague, 128 00, Czechia
Unknown Facility
Aalborg, 9000, Denmark
Unknown Facility
Ballerup Municipality, 2750, Denmark
Unknown Facility
Vejle, 7100, Denmark
Unknown Facility
Lyon, 69000, France
Unknown Facility
Berlin, 12200, Germany
Unknown Facility
Hanover, 30167, Germany
Unknown Facility
Balatonfüred, 8230, Hungary
Unknown Facility
Budapest, 1036, Hungary
Unknown Facility
Budapest, 1083, Hungary
Unknown Facility
Kiskunhalas, 6400, Hungary
Unknown Facility
Zalaegerszeg, 8900, Hungary
Unknown Facility
Siena, 53100, Italy
Unknown Facility
León, 37000, Mexico
Unknown Facility
Obregón, 85100, Mexico
Unknown Facility
Haugesund, 5507, Norway
Unknown Facility
Stavanger, 4010, Norway
Unknown Facility
Krakow, 31-501, Poland
Unknown Facility
Warsaw, 04-730, Poland
Unknown Facility
Barcelona, 08907, Spain
Unknown Facility
Madrid, 28041, Spain
Unknown Facility
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials Study Director
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2004
First Posted
April 21, 2004
Study Start
May 1, 2004
Primary Completion
November 1, 2007
Study Completion
May 1, 2008
Last Updated
July 14, 2017
Results First Posted
July 21, 2009
Record last verified: 2017-07