Randomized, multicenter, double-blind, double-dummy, active-controlled, parallel-design study in approximately 201 postmenopausal women. A subset of subjects (approximately 102) will also participate in a pharmacokinetic (PK) component of the study. Each subject will be randomized to 1 of 3 treatment regimens for 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
205
150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast.
75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast
100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast
Research Site
Daytona Beach, Florida, United States
Research Site
Fort Myers, Florida, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Evansville, Indiana, United States
Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population
Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence.
Time frame: Month 4
Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population
Time frame: 2 months
Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population
Time frame: 3 months
Percent Change From Baseline Urine NTX (Type-1 Collagen Cross-linked N-telopeptide) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population
Urine NTX Bone turnover marker collected after 8 hour fast, 2nd voided urine between 6-9 am assayed by ELISA.
Time frame: 2 months
Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population
ITT Population
Time frame: 3 months
Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population
ITT Population
Time frame: 4 months
Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population
ITT Population
Time frame: 2 months
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Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population
ITT Population
Time frame: 3 months
Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population
ITT Population
Time frame: 4 months