PRIOR Study - A Study of Ibandronate (Boniva) in Postmenopausal Women With Osteoporosis or Osteopenia
An Open-Label, Multi-Center Study to Determine Level of Adherence to Monthly Oral or Every Three Month Intravenous Ibandronate Treatment in Post-Menopausal Women With Osteoporosis or Osteopenia, Who Are GI Intolerant of Daily or Weekly Alendronate or Risendronate
1 other identifier
interventional
545
1 country
60
Brief Summary
The purpose of this study is to evaluate treatment adherence to different regimens of ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. The anticipated time on study treatment is 12 months, and the target sample size is 517 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 Jan 2005
60 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
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
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
1.7 years
November 4, 2015
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of participants who have greater than or equal to (>=) 75 percent (%) adherence using either monthly oral ibandronate or quarterly intravenous (IV) ibandronate
12 months
Secondary Outcomes (3)
Percentage of participants who have an adherence of >= 75% using ibandronate including both switch and non-switch participants
12 months
Percentage of participants with GI events based on severity
Up to 10 months
Percentage of participants who experienced a change in frequency and number of GI events
Up to 10 months
Study Arms (2)
Ibandronate IV
EXPERIMENTALParticipants will receive ibandronate 3 mg IV once every 3 months
Ibandronate Oral
EXPERIMENTALParticipants will receive ibandronate 150 milligrams (mg) tablet once monthly
Interventions
Either 150 mg oral tablet once monthly or 3 mg IV injection once every 3 months
Eligibility Criteria
You may qualify if:
- Women with postmenopausal osteoporosis or osteopenia
- Discontinuation of daily and /or weekly alendronate or risedronate therapy because of GI intolerance (eg, heartburn, acid reflux, stomach upset)
You may not qualify if:
- Inability to stand or sit upright for 60 minutes
- Inability to swallow a tablet whole - Hypersensitivity to any component of Boniva
- Malignant disease diagnosed within previous 10 years (except resected basal cell cancer); contraindications for calcium or vitamin D therapy
- Patients who do not fulfill a minimum 3 months wash-out therapy from any previous bisphosphonate therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Unknown Facility
Montgomery, Alabama, 36116, United States
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Lake Havasu City, Arizona, 86403, United States
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Paradise Valley, Arizona, 85253, United States
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Pine Bluff, Arkansas, 71603, United States
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San Diego, California, 92103, United States
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San Diego, California, 92108, United States
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Santa Monica, California, 90404, United States
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Tacoma, California, 98405, United States
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Vista, California, 92083, United States
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Beverly Hills, Florida, 34464, United States
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Fort Myers, Florida, 33901, United States
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Gainesville, Florida, 32605, United States
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Miami, Florida, 33186, United States
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Ocala, Florida, 34471, United States
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Palm Harbor, Florida, 34684, 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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Coeur d'Alene, Idaho, 83814, United States
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Champaign, Illinois, 61820, United States
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Evansville, Indiana, 47714, United States
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Natchitoches, Louisiana, 71457, United States
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South Portland, Maine, 04106, United States
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Detroit, Michigan, 48202-2689, United States
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Detroit, Michigan, 48236, United States
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Chaska, Minnesota, 55318, United States
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Kansas City, Missouri, 64114, United States
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St Louis, Missouri, 63033, United States
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Billings, Montana, 59101, United States
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Broken Bow, Nebraska, 68822, United States
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Scottsbluff, Nebraska, 69361, United States
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Las Vegas, Nevada, 89104, United States
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Albuquerque, New Mexico, 87106, United States
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New York, New York, 10003, United States
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West Haverstraw, New York, 10993, United States
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Charlotte, North Carolina, 28209, United States
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Durham, North Carolina, 27704, United States
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Salisbury, North Carolina, 28144, United States
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Winston-Salem, North Carolina, 27103, United States
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Bismarck, North Dakota, 58501, United States
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Fargo, North Dakota, 58104, United States
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Canfield, Ohio, 44406, United States
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Columbus, Ohio, 43213, United States
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Mayfield, Ohio, 44143, United States
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Oklahoma City, Oklahoma, 73112, United States
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Wyomissing, Pennsylvania, 19610, United States
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Loris, South Carolina, 29569, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Sioux Falls, South Dakota, 57105, United States
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Watertown, South Dakota, 57201, United States
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Bristol, Tennessee, 37620, United States
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Dallas, Texas, 75231, United States
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Denton, Texas, 76210, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78238, United States
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Seguin, Texas, 78155, United States
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Temple, Texas, 76508, United States
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Norfolk, Virginia, 23502, United States
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Richmond, Virginia, 23294, United States
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Richmond, Virginia, 23298, United States
Unknown Facility
Madison, Wisconsin, 53792, 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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2015
First Posted
November 5, 2015
Study Start
January 1, 2005
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
November 2, 2016
Record last verified: 2016-11