- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00493532
A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
November 1, 2016 updated by: Hoffmann-La Roche
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.
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.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Chai Yi, Taiwan, 613
-
Changhua, Taiwan, 500
-
Kaohsiung, Taiwan, 00833
-
Kaohsiung, Taiwan, 807
-
Kaohsiung, Taiwan, 804
-
Taichung, Taiwan, 404
-
Taichung, Taiwan, 40705
-
Taichung, Taiwan, 402
-
Tainan, Taiwan, 704
-
Tainan, Taiwan, 710
-
Taipei, Taiwan, 100
-
Taipei, Taiwan, 00112
-
Taipei, Taiwan, 886
-
Taoyuan, Taiwan, 333
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 80 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (ACTUAL)
December 1, 2010
Study Completion (ACTUAL)
December 1, 2010
Study Registration Dates
First Submitted
June 27, 2007
First Submitted That Met QC Criteria
June 27, 2007
First Posted (ESTIMATE)
June 28, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML20882
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postmenopausal Osteoporosis
-
AmgenCompletedPostmenopausal Osteoporosis (PMO)Japan
-
Deltanoid PharmaceuticalsCompletedPostmenopausal Osteoporosis, Multiple Sites
-
Riphah International UniversityCompletedPostmenopausal Osteoporosis | Postmenopausal OsteopeniaPakistan
-
AmgenCompletedPostmenopausal OsteoporosisUnited States, Canada, Denmark, Germany, Belgium, Colombia, Czechia, Japan, Mexico, Poland, Switzerland, Hungary, Spain, Australia, Romania, United Kingdom, India, Argentina, Brazil, Dominican Republic, Estonia, Latvia, Lithuania, New...
-
Penn State UniversityCalifornia Dried Plum BoardActive, not recruiting
-
Massachusetts General HospitalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedPostmenopausal OsteoporosisUnited States
-
Sahlgrenska University Hospital, SwedenBioGaia ABCompletedPostmenopausal OsteoporosisSweden
-
Samsung Bioepis Co., Ltd.CompletedPostmenopausal OsteoporosisPoland
-
Organon and CoCompletedOsteoporosis Postmenopausal
-
Nigde Omer Halisdemir UniversityCompletedPostmenopausal OsteoporosisTurkey
Clinical Trials on ibandronate [Bonviva/Boniva]
-
Hoffmann-La RocheCompletedPostmenopausal OsteoporosisUnited States
-
Hoffmann-La RocheCompletedPost-Menopausal OsteoporosisTurkey, Albania, Bosnia and Herzegovina, Croatia, Macedonia, The Former Yugoslav Republic of, Serbia
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisBosnia and Herzegovina
-
Hoffmann-La RocheCompletedPostmenopausal OsteoporosisBelgium, Luxembourg, Austria, Greece, Ireland
-
Hoffmann-La RocheCompletedPostmenopausal OsteoporosisPoland, Slovakia, Hungary, Russian Federation, Latvia, Romania, Slovenia
-
Hoffmann-La RocheCompletedPost-Menopausal OsteoporosisUnited States, Germany, United Kingdom, Spain, Italy, Hungary, Belgium, Mexico, Poland, Denmark, France, Norway, Brazil, Czechia
-
Hoffmann-La RocheCompletedPostmenopausal OsteoporosisUnited States
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisSpain, South Africa, Germany, Mexico, United States, Canada, France, United Kingdom, Italy, Belgium, Australia, Poland, Denmark, Hungary, Czech Republic, Norway
-
Hoffmann-La RocheGlaxoSmithKlineCompletedPost Menopausal OsteoporosisFrance
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisPhilippines, Taiwan, Thailand, Hong Kong, Indonesia