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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: April 5, 2016
Last verified: April 2016

October 16, 2007
April 5, 2016
May 2006
May 2009   (final data collection date for primary outcome measure)
Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
Lumbar spine BMD was measured at Baseline, and Months 6 and 12 using dual-energy x-ray absorptiometry (DXA). Percent change from Baseline to Month 12 was calculated using analysis of covariance.
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
  • Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Lumbar spine BMD was measured at Baseline and Month 6 using DXA. Percent change from Baseline to Month 6 was calculated using analysis of covariance.
  • Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12 [ Time Frame: Baseline and Months 6 and 12 ] [ Designated as safety issue: No ]
    Left total hip BMD was measured by DXA at Baseline, and Months 6 and 12. If there was prosthesis of left hip, the measurement of right total hip BMD was done by DXA. Percent change from Baseline to Months 6 and 12 was calculated using analysis of (co)variance for repeated measurements.
  • Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12 [ Time Frame: Baseline and Months 1, 6 and 12 ] [ Designated as safety issue: No ]
    Serum C-terminal Telopeptide of Type 1 Collagen (sCTX), Serum Procollagen Type 1 N-terminal Propeptide (P1NP) and Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP) are measures of bone resorption and are measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Months 1, 6 and 12 was calculated using analysis of covariance for repeated measurements.
  • Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Worsening in BMD was defined as BMD T-score at any site less than or equal to (≤) - 2.5 standard deviations and/or worsening in BMD of at least 7% at any site.
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 monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Postmenopausal Osteoporosis
  • Drug: Placebo
    po monthly for 12 months
  • Drug: ibandronate
    150mg po monthly for 12 months
    Other Name: Bonviva/Boniva
  • Experimental: Ibandronate
    Participants received monthly oral ibandronate (150 milligrams [mg]) for 12 months.
    Intervention: Drug: ibandronate
  • Placebo Comparator: Placebo
    Participants received monthly oral placebo for 12 months.
    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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00545051
ML20088
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
GlaxoSmithKline
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2016

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