A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
NCT ID: NCT00541658
Last Updated: 2013-04-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
923 participants
INTERVENTIONAL
2007-10-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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5 mg Before Breakfast
5 mg / Immediate-release Risedronate (At Least 30 Minutes Before Breakfast)
risedronate
5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily
35 mg After Breakfast
35 mg / Delayed-release Risedronate (Immediately Following Breakfast)
risedronate
35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly
35 mg Before Breakfast
35 mg / Delayed-release Risedronate (At Least 30 Minutes Before Breakfast)
risedronate
35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly
Interventions
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risedronate
5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily
risedronate
35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly
risedronate
35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \>5 years since last menses natural or surgical
* have lumbar spine or total hip BMD more that 2.5 SD below the young adult mean, or have lumbar spine or total hip BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture
Exclusion Criteria
* BMI \>32 kg/m
* use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
* hypocalcemia or hypercalcemia of any cause
* markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator
50 Years
FEMALE
No
Sponsors
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Warner Chilcott
INDUSTRY
Responsible Party
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Principal Investigators
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Ana Balske, MD, PhD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Oakland, California, United States
Research Site
San Diego, California, United States
Research Facility
Walnut Creek, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Lakewood, Colorado, United States
Research Site
Leesburg, Florida, United States
Research Site
Melbourne, Florida, United States
Research Site
South Miami, Florida, United States
Research Site
Gainesville, Georgia, United States
Research Site
Champaign, Illinois, United States
Research Site
Chicago, Illinois, United States
Research Site
Bethesda, Maryland, United States
Research Site
Brockton, Massachusetts, United States
Research Site
Omaha, Nebraska, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Greenville, North Carolina, United States
Research Site
Portland, Oregon, United States
Research Site
Seattle, Washington, United States
Research Site
Madison, Wisconsin, United States
Research Site
Buenos Aires, , Argentina
Research Facility
Diepenbeek, , Belgium
Research Site
Ghent, , Belgium
Research Site
Leuven, , Belgium
Research Site
Hamilton, Ontario, Canada
Research Site
Kitchener, Ontario, Canada
Research Site
Newmarket, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Saint-Eustache, Quebec, Canada
Research Site
Saskatoon, Saskatchewan, Canada
Research Site
Pärnu, , Estonia
Research Site
Tallinn, , Estonia
Research Site
Tartu, , Estonia
Research Site
Amiens, , France
Research Site
Lyon, , France
Research Site
Orléans, , France
Research Site
Vandœuvre-lès-Nancy, , France
Research Site
Balatonfüred, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Eger, , Hungary
Research Site
Győr, , Hungary
Research Site
Koranyi Sandor, , Hungary
Research Site
Bialystok, , Poland
Research Site
Warsaw, , Poland
Countries
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References
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McClung MR, Miller PD, Brown JP, Zanchetta J, Bolognese MA, Benhamou CL, Balske A, Burgio DE, Sarley J, McCullough LK, Recker RR. Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet. Osteoporos Int. 2012 Jan;23(1):267-76. doi: 10.1007/s00198-011-1791-y. Epub 2011 Sep 27.
Other Identifiers
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2007008
Identifier Type: -
Identifier Source: org_study_id
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