A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis
NCT ID: NCT02598934
Last Updated: 2016-03-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
308 participants
INTERVENTIONAL
2004-08-31
2006-05-31
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 Group 1
Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 1 will receive a physician consultation after 4 months of treatment to review bone turnover test results.
Ibandronate
Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
Ibandronate Group 2
Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 2 will not receive a physician consultation.
Ibandronate
Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
Interventions
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Ibandronate
Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Naive to prior bisphosphonate therapy
Exclusion Criteria
* Inability to swallow a tablet whole
* Hypersensitivity to any component of ibandronate
* Hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months
* Other osteoporosis drug within last 3 months
* Malignant disease diagnosed within previous 10 years, except resected basal cell cancer
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
Chandler, Arizona, United States
Peoria, Arizona, United States
Hot Springs, Arkansas, United States
Pine Bluff, Arkansas, United States
Anaheim, California, United States
Beverly Hills, California, United States
Carmichael, California, United States
Wilmington, Delaware, United States
DeLand, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Palm Habor, Florida, United States
Palm Springs, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Rome, Georgia, United States
Morton Grove, Illinois, United States
Indianapolis, Indiana, United States
Waterloo, Iowa, United States
Baltimore, Maryland, United States
Hagerstown, Maryland, United States
Reistertown, Maryland, United States
Olive Branch, Mississippi, United States
Jefferson City, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Bloomfield, New Jersey, United States
New York, New York, United States
The Bronx, New York, United States
Morehead City, North Carolina, United States
Morganton, North Carolina, United States
Raleigh, North Carolina, United States
Oklahoma City, Oklahoma, United States
Medford, Oregon, United States
Doylestown, Pennsylvania, United States
Langhorne, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Mt. Pleasant, South Carolina, United States
Spartanburg, South Carolina, United States
Morristown, Tennessee, United States
Murfreesboro, Tennessee, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
Texarkana, Texas, United States
Richmond, Virginia, United States
Tacoma, Washington, United States
Madison, Wisconsin, United States
Ponce, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Countries
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Other Identifiers
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ML18057
Identifier Type: -
Identifier Source: org_study_id
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