Conditions: Postmenopausal Osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 205
Healthy volunteers: yes

Brief summary:
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.

Detailed description:

Arms:
arm 1: 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast. arm 2: 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast arm 3: 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast

Interventions: intervention 1: 150 mg intervention 2: 75 mg intervention 3: 100 mg
Intervention descriptions: intervention 1: 150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast. intervention 2: 75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast intervention 3: 100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast

Protocol document: