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

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ClinicalTrials.gov Identifier: NCT00545051
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : May 12, 2016
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE October 16, 2007
First Posted Date  ICMJE October 17, 2007
Results First Submitted Date  ICMJE April 5, 2016
Results First Posted Date  ICMJE May 12, 2016
Last Update Posted Date May 12, 2016
Study Start Date  ICMJE May 2006
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2016)
Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 [ Time Frame: Baseline and Month 12 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2007)
Change (%) from baseline in mean lumbar spine (L1-L4) BMD at 12 months.
Change History Complete list of historical versions of study NCT00545051 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2016)
  • Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6 [ Time Frame: Baseline and Month 6 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2007)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postmenopausal Osteoporosis
Intervention  ICMJE
  • Drug: Placebo
    po monthly for 12 months
  • Drug: ibandronate
    150mg po monthly for 12 months
    Other Name: Bonviva/Boniva
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2009)
140
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00545051
Other Study ID Numbers  ICMJE ML20088
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date April 2016

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