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A Study of Ibandronate (Bonviva) in Patients 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: NCT02598440
Recruitment Status : Completed
First Posted : November 5, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE November 4, 2015
First Posted Date  ICMJE November 5, 2015
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE March 2004
Actual Primary Completion Date May 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
Percentage of participants preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate [ Time Frame: Up to 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
  • Percentage of participants perceiving the once-monthly dosing of ibandronate to be more convenient over once-weekly dosing of alendronate. [ Time Frame: Up to 6 months ]
  • Incidence of adverse events [ Time Frame: Up to approximately 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis
Official Title  ICMJE A Randomized, Open-Label, Muti-Center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once-Monthly Ibandronate and Once-Weekly Alendronate. A Six Month, Two-Sequence, and Two-Period Crossover Study
Brief Summary This study will evaluate participant-reported preference for either ibandronate or a comparator drug in women with postmenopausal osteoporosis. The anticipated time of study treatment is 6 months, and the target sample size is 338 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 Postmenopausal Osteoporosis
Intervention  ICMJE
  • Drug: Alendronate
    Participants wil receive once-weekly oral alendronate (70 mg tablet)
  • Drug: Ibandronate
    Participants wil receive once-monthly oral ibandronate (150 mg tablet)
    Other Name: Bonviva
Study Arms  ICMJE
  • Experimental: Group A: Ibandronate Then Alendronate
    Participants wil receive once-monthly oral ibandronate (150 mg tablet) for 3 months followed by and once-weekly oral alendronate (70 mg tablet) in crossover design for 12 weeks.
    Interventions:
    • Drug: Alendronate
    • Drug: Ibandronate
  • Experimental: Group B: Alendronate Then Ibandronate
    Participants will receive once-weekly oral alendronate (70 mg tablet) for 12 weeks followed by once-monthly oral ibandronate (150 mg tablet) for 3 months.
    Interventions:
    • Drug: Alendronate
    • Drug: Ibandronate
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: December 1, 2015)
341
Original Actual Enrollment  ICMJE
 (submitted: November 4, 2015)
338
Actual Study Completion Date  ICMJE May 2005
Actual Primary Completion Date May 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ambulatory women
  • Diagnosis of post-menopausal osteoporosis
  • Women who have never received bisphosphonate therapy, or who have discontinued daily bisphosphonates at least 3 months prior to study entry

Exclusion Criteria:

  • Inability to stand or sit in the upright position for greater than or equal to 60 minutes
  • Allergy to bisphosphonates;
  • Previous or current treatment with weekly or monthly bisphosphonates, or daily bisphosphonates for the last 3 months prior to study entry
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, 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 NCT02598440
Other Study ID Numbers  ICMJE MA17843
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 Chair: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

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