A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis
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
1 other identifier
interventional
341
1 country
54
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2004
54 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
March 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 4, 2015
CompletedFirst Posted
Study publicly available on registry
November 5, 2015
CompletedNovember 2, 2016
November 1, 2016
1.2 years
November 4, 2015
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of participants preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate
Up to 6 months
Secondary Outcomes (2)
Percentage of participants perceiving the once-monthly dosing of ibandronate to be more convenient over once-weekly dosing of alendronate.
Up to 6 months
Incidence of adverse events
Up to approximately 1 year
Study Arms (2)
Group A: Ibandronate Then Alendronate
EXPERIMENTALParticipants 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.
Group B: Alendronate Then Ibandronate
EXPERIMENTALParticipants 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
Participants wil receive once-weekly oral alendronate (70 mg tablet)
Participants wil receive once-monthly oral ibandronate (150 mg tablet)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Unknown Facility
Huntsville, Alabama, 35801, United States
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Phoenix, Arizona, 85006, United States
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Tempe, Arizona, 85282, United States
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Laguna Woods, California, 92653, United States
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Mission Viejo, California, 92691, United States
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Oceanside, California, 92056, United States
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San Diego, California, 92103-6204, United States
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San Diego, California, 92108, United States
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Santa Clarita, California, 91321, United States
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Upland, California, 91786, United States
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Vista, California, 92084, United States
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Denver, Colorado, 80202, United States
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Cromwell, Connecticut, 06416, United States
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Waterbury, Connecticut, 06708, United States
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Newark, Delaware, 19713, United States
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Aventura, Florida, 33180, United States
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Miami, Florida, 33176, United States
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Pembroke Pines, Florida, 33024, United States
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Tampa, Florida, 33614, United States
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West Palm Beach, Florida, 33409, United States
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Augusta, Georgia, 30904, United States
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Decatur, Georgia, 30033, United States
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Chicago, Illinois, 60612, United States
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Indianapolis, Indiana, 46202, United States
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South Bend, Indiana, 46601, United States
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Des Moines, Iowa, 50314, United States
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Wichita, Kansas, 67207, United States
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Bangor, Maine, 04401, United States
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Baltimore, Maryland, 21209, United States
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Worcester, Massachusetts, 01610, United States
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Florissant, Missouri, 63031, United States
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St Louis, Missouri, 63128, United States
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Reno, Nevada, 89502, United States
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Princeton, New Jersey, 08540, United States
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Toms River, New Jersey, 08753, United States
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Orchard Park, New York, 14127, United States
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Raleigh, North Carolina, 27609, United States
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Eugene, Oregon, 97401, United States
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Duncansville, Pennsylvania, 16635, United States
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Erie, Pennsylvania, 16502, United States
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Erie, Pennsylvania, 16506, United States
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Philadelphia, Pennsylvania, 19114, United States
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Philadelphia, Pennsylvania, 19148, United States
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Wyomissing, Pennsylvania, 19610, United States
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Warwick, Rhode Island, 02886, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Nashville, Tennessee, 37203, United States
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Dallas, Texas, 75234, United States
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Houston, Texas, 77024, United States
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Newport News, Virginia, 23602, United States
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Richmond, Virginia, 23235, United States
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Seattle, Washington, 98105, United States
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Seattle, Washington, 98144, United States
Unknown Facility
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
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
November 4, 2015
First Posted
November 5, 2015
Study Start
March 1, 2004
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
November 2, 2016
Record last verified: 2016-11