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A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.

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.
 
ClinicalTrials.gov Identifier: NCT00377234
Recruitment Status : Completed
First Posted : September 18, 2006
Results First Posted : July 22, 2015
Last Update Posted : August 1, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE September 15, 2006
First Posted Date  ICMJE September 18, 2006
Results First Submitted Date  ICMJE June 25, 2015
Results First Posted Date  ICMJE July 22, 2015
Last Update Posted Date August 1, 2016
Study Start Date  ICMJE May 2006
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2015)
Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing [ Time Frame: at 6 months ]
Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2006)
Proportion of patients preferring once monthly dosing with Boniva over once weekly dosing with risedronate
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2015)
  • Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate [ Time Frame: within 6 months ]
    Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.
  • Intensity of Upper Gastrointestinal (GI) Symptoms [ Time Frame: within 3 months ]
    Patients were given a diary in which to record their upper GI events during the first 12 weeks of treatment. The diary was to be completed weekly and the occurrence of symptoms and their intensity recorded using a pre-defined list.
  • Mean Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP) [ Time Frame: 3 months ]
    During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made.
  • Median Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP) [ Time Frame: 3 months ]
    During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2006)
Efficacy: Convenience of monthly Boniva vs weekly risedronate; change in serum CTX at end of 1st treatment period; upper gastrointestinal symptoms during 1st treatment period. Safety: AEs, lab parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
Official Title  ICMJE Randomized, Open-label, Multi-center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once Monthly Ibandronate and Once Weekly Risedronate. A Six Month, Two-sequence and Two-period Crossover Study.
Brief Summary This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, 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: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Post Menopausal Osteoporosis
Intervention  ICMJE
  • Drug: Risedronate
    35mg po weekly for 12 weeks
  • Drug: ibandronate [Bonviva/Boniva]
    150mg po monthly for 3 months
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: ibandronate [Bonviva/Boniva]
  • Active Comparator: 2
    Intervention: Drug: Risedronate
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: February 17, 2009)
356
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ambulatory women with post-menopausal osteoporosis;
  • patients who are bisphosphonate-naive, or who have previously received oral daily or i.v. bisphosphonate therapy (fulfilling certain criteria detailed in the protocol).

Exclusion Criteria:

  • malignant disease diagnosed within previous 10 years (except for successfully resected basal cell cancer;) breast cancer within previous 20 years;
  • inability to stand or sit upright for at least 60 minutes;
  • disease/disorder/treatment with drugs known to influence bone metabolism.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 55 Years to 80 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00377234
Other Study ID Numbers  ICMJE MA19547
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 Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date July 2016

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