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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00493532
First received: June 27, 2007
Last updated: March 15, 2011
Last verified: March 2011
History of Changes

June 27, 2007
March 15, 2011
 
December 2010   (final data collection date for primary outcome measure)
Mean change (%) in spinal BMD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mean change (%) of spinal BMD at 12 months.
Complete list of historical versions of study NCT00493532 on ClinicalTrials.gov Archive Site
  • Mean change in hip BMD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean change in Serum CTX [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Mean change in hip and spinal BMD [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • AEs and clinical fractures [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Percentage change from baseline in OPSAT-Q [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Efficacy: Mean change (%) of hip BMD at 12 months, serum CTX at 6 and 12 months, and hip and spinal BMD at 6 months. Safety: AEs, clinical fractures. Satisfaction: Percentage change from baseline in OPSAT-Q at 12 months.
 
 
 
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.

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.
 
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Post-Menopausal Osteoporosis
Drug: ibandronate [Bonviva/Boniva]
3mg iv every 3 months
Experimental: 1
Intervention: Drug: ibandronate [Bonviva/Boniva]
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2010
December 2010   (final data collection date for primary outcome measure)

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).
Female
up to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00493532
ML20882
 
Disclosures Group, Hoffmann-La Roche
Hoffmann-La Roche
 
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP