Conditions: Postmenopausal Women
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 181
Healthy volunteers: yes

Brief summary:
To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.

Detailed description:
To compare the efficacy, based on the bone turnover marker (BTM) serum Type I collagen C-telopeptide (CTx), of a 50 mg delayed-release risedronate tablet, administered immediately after a typical breakfast, to that of a 35 mg immediate-release tablet, administered according to labeling instructions (ie, at least 30 minutes prior to breakfast) in postmenopausal women after 13 weeks of treatment.

Arms:
arm 1: 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks arm 2: 35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks arm 3: 50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks arm 4: 50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks

Interventions: intervention 1: risedronate intervention 2: risedronate intervention 3: risedronate intervention 4: risedronate
Intervention descriptions: intervention 1: 35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks intervention 2: 35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks intervention 3: 50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks intervention 4: 50mg delayed release risedronate tablet before breakfast, once a week for 13 weeks

Protocol document: