A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis

Completed · Phase 3

Conditions studied: Postmenopausal Osteoporosis

In brief

The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

Key facts

Study ID

NCT00541658

Run by

Warner Chilcott

People needed

923

Starts

2007-10-01

Expected to finish

2010-04-01

Last updated by the study team

2013-04-22

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female: 50 years of age or older
• >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

You may not qualify if…

• history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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