PRIOR Study - A Study of Ibandronate (Boniva) in Postmenopausal Women With Osteoporosis or Osteopenia
NCT ID: NCT02598453
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
545 participants
INTERVENTIONAL
2005-01-31
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ibandronate IV
Participants will receive ibandronate 3 mg IV once every 3 months
Ibandronate
Either 150 mg oral tablet once monthly or 3 mg IV injection once every 3 months
Ibandronate Oral
Participants will receive ibandronate 150 milligrams (mg) tablet once monthly
Ibandronate
Either 150 mg oral tablet once monthly or 3 mg IV injection once every 3 months
Interventions
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Ibandronate
Either 150 mg oral tablet once monthly or 3 mg IV injection once every 3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Discontinuation of daily and /or weekly alendronate or risedronate therapy because of GI intolerance (eg, heartburn, acid reflux, stomach upset)
Exclusion Criteria
* 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
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Montgomery, Alabama, United States
Lake Havasu City, Arizona, United States
Paradise Valley, Arizona, United States
Pine Bluff, Arkansas, United States
San Diego, California, United States
San Diego, California, United States
Santa Monica, California, United States
Tacoma, California, United States
Vista, California, United States
Beverly Hills, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Palm Harbor, Florida, United States
West Palm Beach, Florida, United States
Augusta, Georgia, United States
Coeur d'Alene, Idaho, United States
Champaign, Illinois, United States
Evansville, Indiana, United States
Natchitoches, Louisiana, United States
South Portland, Maine, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Chaska, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Billings, Montana, United States
Broken Bow, Nebraska, United States
Scottsbluff, Nebraska, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
New York, New York, United States
West Haverstraw, New York, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Salisbury, North Carolina, United States
Winston-Salem, North Carolina, United States
Bismarck, North Dakota, United States
Fargo, North Dakota, United States
Canfield, Ohio, United States
Columbus, Ohio, United States
Mayfield, Ohio, United States
Oklahoma City, Oklahoma, United States
Wyomissing, Pennsylvania, United States
Loris, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Sioux Falls, South Dakota, United States
Watertown, South Dakota, United States
Bristol, Tennessee, United States
Dallas, Texas, United States
Denton, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Seguin, Texas, United States
Temple, Texas, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Madison, Wisconsin, United States
Countries
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Other Identifiers
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ML18058
Identifier Type: -
Identifier Source: org_study_id