A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.
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ClinicalTrials.gov Identifier: NCT00545207 |
Recruitment Status
:
Completed
First Posted
: October 17, 2007
Last Update Posted
: January 26, 2017
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
Tracking Information | ||||
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First Submitted Date ICMJE | October 16, 2007 | |||
First Posted Date ICMJE | October 17, 2007 | |||
Last Update Posted Date | January 26, 2017 | |||
Study Start Date ICMJE | Not Provided | |||
Actual Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Trabecular BV/TV at distal radius of non-dominant arm [ Time Frame: 12 arms ] | |||
Original Primary Outcome Measures ICMJE |
Trabecular BV/TV at distal radius of non-dominant arm at 1 year. | |||
Change History | Complete list of historical versions of study NCT00545207 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Efficacy: Trabecular BV/TV at distal radius of non-dominant arm at 6 months and 2 years; bone density, trabecular BV/TV at distal tibia at 6 months, 1 and 2 years; serum CTX; lumbar, hip and wrist BMD at 1 and 2 years. Safety: AEs and laboratory tests. | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia. | |||
Official Title ICMJE | A Randomized, Double-blind Study of the Effect of Oral Monthly Bonviva on in Vivo Bone Micro-architecture Parameters in Post-menopausal Women With Osteopenia | |||
Brief Summary | This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Post-Menopausal Osteopenia | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
150 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date | September 2010 | |||
Actual Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 55 Years to 75 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00545207 | |||
Other Study ID Numbers ICMJE | ML19357 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Hoffmann-La Roche | |||
Study Sponsor ICMJE | Hoffmann-La Roche | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Hoffmann-La Roche | |||
Verification Date | January 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |