A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
An Open Label Study to Evaluate the Effect on Bone Mineral Density, and the Safety, of Quarterly Intravenous Bonviva in Patients With Post-menopausal Osteoporosis.
1 other identifier
expanded_access
N/A
1 country
14
Brief Summary
This single arm study will assess the efficacy and safety of quarterly intravenous Bonviva in women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2007
Typical duration for all trials
14 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
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 27, 2007
CompletedFirst Posted
Study publicly available on registry
June 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedNovember 2, 2016
November 1, 2016
3.5 years
June 27, 2007
November 1, 2016
Conditions
Interventions
3mg iv every 3 months
Eligibility Criteria
You may qualify if:
- post-menopausal women with osteoporosis;
- \<=80 years of age;
- naive to oral bisphosphonates, or have discontinued daily and/or weekly bisphosphonate treatment for \>1 year.
You may not qualify if:
- metabolic bone disease other than post-menopausal osteoporosis;
- treatment with other drugs affecting bone metabolism within last 6 months;
- previous or current malignant disease (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Unknown Facility
Chai Yi, 613, Taiwan
Unknown Facility
Changhua, 500, Taiwan
Unknown Facility
Kaohsiung City, 00833, Taiwan
Unknown Facility
Kaohsiung City, 804, Taiwan
Unknown Facility
Kaohsiung City, 807, Taiwan
Unknown Facility
Taichung, 402, Taiwan
Unknown Facility
Taichung, 404, Taiwan
Unknown Facility
Taichung, 40705, Taiwan
Unknown Facility
Tainan, 704, Taiwan
Unknown Facility
Tainan, 710, Taiwan
Unknown Facility
Taipei, 00112, Taiwan
Unknown Facility
Taipei, 100, Taiwan
Unknown Facility
Taipei, 886, Taiwan
Unknown Facility
Taoyuan District, 333, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2007
First Posted
June 28, 2007
Study Start
June 1, 2007
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
November 2, 2016
Record last verified: 2016-11