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A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545051
First received: October 16, 2007
Last updated: November 3, 2014
Last verified: November 2014

October 16, 2007
November 3, 2014
May 2006
May 2009   (final data collection date for primary outcome measure)
Percentage change from baseline in mean lumbar spine (L1-L4) BMD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change (%) from baseline in mean lumbar spine (L1-L4) BMD at 12 months.
Complete list of historical versions of study NCT00545051 on ClinicalTrials.gov Archive Site
  • Change in mean lumbar spine BMD [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in total hip BMD [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Change in bone turnover markers [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: No ]
  • Withdrawal rates due to worsening BMD [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • AEs, clinical fractures, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Efficacy: Change in mean lumbar spine BMD at 6 months, & total hip BMD at 6 & 12 months; change in bone turnover markers at 1,6,12 months; difference in withdrawal rates due to worsening in BMD at 6 months. Safety: AEs, clinical fractures, lab tests.
Not Provided
Not Provided
 
A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.
A Randomized, Double-blind Study to Evaluate the Effect of Once Monthly Bonviva on Lumbar Bone Mineral Density in the Prevention of Glucocorticoid-induced Osteoporosis in Post-menopausal Women

This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po m onthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopau sal women. Patients will be randomized to receive either Bonviva 150mg po or pla cebo monthly, with vitamin D and calcium supplementation. The anticipated time o n study treatment is 1-2 years, and the target sample size is 100-500 individual s.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Post-Menopausal Osteoporosis
  • Drug: ibandronate [Bonviva/Boniva]
    150mg po monthly for 12 months
  • Drug: Placebo
    po monthly for 12 months
  • Experimental: 1
    Intervention: Drug: ibandronate [Bonviva/Boniva]
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • post-menopausal women, 50-85 years of age;
  • any inflammatory rheumatoid disease including polymyalgia rheumatica;
  • receiving treatment with 5-15 mg/day of prednisolone.

Exclusion Criteria:

  • previous treatment with an iv bisphosphonate at any time;
  • previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within last year, or >3 months of treatment within last 2 years;
  • treatment with parathyroid hormone in last 2 years;
  • inability to stand or sit in an upright position for at least 60 minutes;
  • inability to swallow a tablet whole;
  • history of major gastrointestinal disease.
Female
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00545051
ML20088
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
GlaxoSmithKline
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

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