Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00493532
First received: June 27, 2007
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: ibandronate [Bonviva/Boniva]
Phase 4

Study Type: Expanded Access     What is Expanded Access?
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Study Start Date: June 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ibandronate [Bonviva/Boniva]
    3mg iv every 3 months
  Eligibility

Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493532

Locations
Taiwan
Chai Yi, Taiwan, 613
Changhua, Taiwan, 500
Kaohsiung, Taiwan, 00833
Kaohsiung, Taiwan, 804
Kaohsiung, Taiwan, 807
Taichung, Taiwan, 402
Taichung, Taiwan, 404
Taichung, Taiwan, 40705
Tainan, Taiwan, 704
Tainan, Taiwan, 710
Taipei, Taiwan, 00112
Taipei, Taiwan, 100
Taipei, Taiwan, 886
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00493532     History of Changes
Other Study ID Numbers: ML20882 
Study First Received: June 27, 2007
Last Updated: November 1, 2016
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Ibandronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016