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

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00493532
First Posted: June 28, 2007
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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
Postmenopausal Osteoporosis Drug: ibandronate [Bonviva/Boniva]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: June 27, 2007
First Posted: June 28, 2007
Last Update Posted: November 2, 2016
Last Verified: November 2016

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