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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

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.

Condition or disease Intervention/treatment Phase
Post Menopausal Osteoporosis Drug: Risedronate Drug: ibandronate [Bonviva/Boniva] Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : May 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 3 months

Active Comparator: 2 Drug: Risedronate
35mg po weekly for 12 weeks




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377234


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35294-3708
United States, Arizona
Mesa, Arizona, United States, 85213
Scottsdale, Arizona, United States, 85251
United States, Arkansas
Jonesboro, Arkansas, United States, 72401
United States, California
Anaheim, California, United States, 92801
San Diego, California, United States, 92108
United States, Connecticut
Waterbury, Connecticut, United States, 06708
United States, Florida
Boynton Beach, Florida, United States, 33437
Jupiter, Florida, United States, 33458
Largo, Florida, United States, 33777
Leesburg, Florida, United States, 34748
Merritt Island, Florida, United States, 32952
Ocala, Florida, United States, 34471
Pembroke Pines, Florida, United States, 33024
Spring Hill, Florida, United States, 34667
St Petersburg, Florida, United States, 33606
Tampa, Florida, United States, 33614
West Palm Beach, Florida, United States, 33409
United States, Georgia
Douglasville, Georgia, United States, 30134
Gainesville, Georgia, United States, 30501
Marietta, Georgia, United States, 30060
United States, Kentucky
Madisonville, Kentucky, United States, 42431
United States, Maryland
Bethesda, Maryland, United States, 20817
United States, Montana
Missoula, Montana, United States, 59801
United States, Nebraska
Omaha, Nebraska, United States, 68134
United States, North Carolina
Morehead City, North Carolina, United States, 28557
New Bern, North Carolina, United States, 28562
United States, North Dakota
Jamestown, North Dakota, United States, 58401
United States, Ohio
Cincinnati, Ohio, United States, 45224
Cincinnati, Ohio, United States, 45236
Mogadore, Ohio, United States, 44260
United States, Oklahoma
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
Erie, Pennsylvania, United States, 16506
Feasterville, Pennsylvania, United States, 19053
Philadelphia, Pennsylvania, United States, 19114
United States, South Carolina
Anderson, South Carolina, United States, 29621
United States, Tennessee
Memphis, Tennessee, United States, 38120
Selmer, Tennessee, United States, 38375
United States, Texas
Bedford, Texas, United States, 76021
Bryan, Texas, United States, 77802
Dallas, Texas, United States, 75231
Houston, Texas, United States, 77024
Houston, Texas, United States, 77030
Temple, Texas, United States, 76502
United States, Virginia
Richmond, Virginia, United States, 23235
Richmond, Virginia, United States, 23294
United States, Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00377234    
Other Study ID Numbers: MA19547
First Posted: September 18, 2006    Key Record Dates
Results First Posted: July 22, 2015
Last Update Posted: August 1, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Risedronic Acid
Ibandronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents