A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with Low Bone Mineral Density.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
370
tablet, 5 mg risedronate daily for 6 months
tablet, 100 mg risedronate monthly for 6 months
tablet, 150 mg risedronate monthly for 6 months
Research Site
Daytona Beach, Florida, United States
Research Site
Gainesville, Florida, United States
Research Site
Shawnee Mission, Kansas, United States
Evaluate the safety of 3 once-monthly dosing regimens of risedronate, 100 mg, 150 mg and 200 mg, compared to a once-daily dosing regimen, 5 mg, as assessed by clinical laboratory values and adverse event (AE) profiles
Time frame: 6 months
Evaluate the efficacy of 3 once-monthly dosing regimens or risedronate compared to a once-daily dosing regimen and to evaluate the PK/PD of monthly and daily dose regimens
Time frame: 6 months
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tablet, 200 mg risedronate monthly for 6 months
Research Site
San Antonio, Texas, United States
Research Site
Hamilton, Ontario, Canada
Research Facility
Montreal, Quebec, Canada
Research Facility
Sainte-Foy, Quebec, Canada
Research Facility
Zagreb, Croatia
Research Facility
Amsterdam, Netherlands
Research Facility
Leiden, Netherlands
...and 4 more locations