Back to resultsA Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
Primary Purpose
Postmenopausal Osteoporosis
Status
No longer available
Phase
Locations
Taiwan
Study Type
Expanded Access
Intervention
ibandronate [Bonviva/Boniva]
Sponsored by
About this trial
This is an expanded access trial for Postmenopausal Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00493532
Brief Title
A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
Official Title
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.
Study Type
Expanded Access
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
No longer available
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ibandronate [Bonviva/Boniva]
Intervention Description
3mg iv every 3 months
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Chai Yi
ZIP/Postal Code
613
Country
Taiwan
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
City
Kaohsiung
ZIP/Postal Code
00833
Country
Taiwan
City
Kaohsiung
ZIP/Postal Code
804
Country
Taiwan
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
City
Taipei
ZIP/Postal Code
886
Country
Taiwan
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
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