A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
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.
1 other identifier
interventional
356
1 country
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2006
Typical duration for phase_4
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 15, 2006
CompletedFirst Posted
Study publicly available on registry
September 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
July 22, 2015
CompletedAugust 1, 2016
July 1, 2016
2.3 years
September 15, 2006
June 25, 2015
July 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing
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.
at 6 months
Secondary Outcomes (4)
Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate
within 6 months
Intensity of Upper Gastrointestinal (GI) Symptoms
within 3 months
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)
3 months
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)
3 months
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Unknown Facility
Birmingham, Alabama, 35294-3708, United States
Unknown Facility
Mesa, Arizona, 85213, United States
Unknown Facility
Scottsdale, Arizona, 85251, United States
Unknown Facility
Jonesboro, Arkansas, 72401, United States
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
Waterbury, Connecticut, 06708, United States
Unknown Facility
Boynton Beach, Florida, 33437, United States
Unknown Facility
Jupiter, Florida, 33458, United States
Unknown Facility
Largo, Florida, 33777, United States
Unknown Facility
Leesburg, Florida, 34748, United States
Unknown Facility
Merritt Island, Florida, 32952, United States
Unknown Facility
Ocala, Florida, 34471, United States
Unknown Facility
Pembroke Pines, Florida, 33024, United States
Unknown Facility
Spring Hill, Florida, 34667, United States
Unknown Facility
St. Petersburg, Florida, 33606, United States
Unknown Facility
Tampa, Florida, 33614, United States
Unknown Facility
West Palm Beach, Florida, 33409, United States
Unknown Facility
Douglasville, Georgia, 30134, United States
Unknown Facility
Gainesville, Georgia, 30501, United States
Unknown Facility
Marietta, Georgia, 30060, United States
Unknown Facility
Madisonville, Kentucky, 42431, United States
Unknown Facility
Bethesda, Maryland, 20817, United States
Unknown Facility
Missoula, Montana, 59801, United States
Unknown Facility
Omaha, Nebraska, 68134, United States
Unknown Facility
Morehead City, North Carolina, 28557, United States
Unknown Facility
New Bern, North Carolina, 28562, United States
Unknown Facility
Jamestown, North Dakota, 58401, United States
Unknown Facility
Cincinnati, Ohio, 45224, United States
Unknown Facility
Cincinnati, Ohio, 45236, United States
Unknown Facility
Mogadore, Ohio, 44260, United States
Unknown Facility
Tulsa, Oklahoma, 74104, United States
Unknown Facility
Duncansville, Pennsylvania, 16635, United States
Unknown Facility
Erie, Pennsylvania, 16506, United States
Unknown Facility
Feasterville, Pennsylvania, 19053, United States
Unknown Facility
Philadelphia, Pennsylvania, 19114, United States
Unknown Facility
Anderson, South Carolina, 29621, United States
Unknown Facility
Memphis, Tennessee, 38120, United States
Unknown Facility
Selmer, Tennessee, 38375, United States
Unknown Facility
Bedford, Texas, 76021, United States
Unknown Facility
Bryan, Texas, 77802, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Houston, Texas, 77024, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Temple, Texas, 76502, United States
Unknown Facility
Richmond, Virginia, 23235, United States
Unknown Facility
Richmond, Virginia, 23294, United States
Unknown Facility
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2006
First Posted
September 18, 2006
Study Start
May 1, 2006
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
August 1, 2016
Results First Posted
July 22, 2015
Record last verified: 2016-07