A Study of Monthly Risedronate for Osteoporosis

Completed · Phase 3

Conditions studied: Postmenopausal Osteoporosis

In brief

The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

Key facts

Study ID

NCT00247273

Run by

Warner Chilcott

People needed

1294

Starts

2005-10-01

Expected to finish

2008-04-01

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 BMD (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine 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 (body mass index) >32 kg/m\^2
• 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 — Lakewood, Colorado, United States
• Research Site — Gainesville, Georgia, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — West Haverstraw, New York, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Portland, Oregon, United States
• Research Site — Buenos Aires, Buenos Aires, Argentina
• Research Site — Capital Federal, Argentina
• Research Site — Geelong, Australia
• Research Site — Heidelberg, Victoria, Australia
• Research Site — Saint Leonards, Australia
• Research Site — Brussels, Belgium
• Research Site — Ghent, Belgium
• Research Site — Leuven, Belgium
• Research Site — Liège, Belgium
• Research Site — Mont Godinne, Belgium
• Research Site — Rio de Janeiro, Brazil
• Research Site — São Paulo, Brazil
• Research Site — Calgary, Canada
• Research Site — Montreal, Canada
• Research Site — Sainte-Foy, Canada
• Research Site — Saskatoon, Canada
• Research Site — Pärnu, Estonia
• Research Site — Tartu, Estonia

Full record on ClinicalTrials.gov

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