Conditions: Osteoporosis
Keywords: Osteoporosis Postmenopausal MK-5442
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 383
Healthy volunteers: no

Brief summary:
The purpose of this study was to identify an appropriate dose of

MK-5442 that produced an osteoanabolic effect without causing hypercalcemia in postmenopausal women with osteoporosis.

Detailed description:
Amendment 4 of the protocol changed the duration of the study from 2 years to 6 months.

Arms:
arm 1: Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months. arm 2: Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months. arm 3: Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months. arm 4: Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months. arm 5: Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months. arm 6: Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.

Interventions: intervention 1: MK-5442 intervention 2: Placebo intervention 3: Vitamin D3 intervention 4: Calcium carbonate
Intervention descriptions: intervention 1: MK-5442 2.5 mg, 5 mg, 7.5 mg, 10 mg, or 15 mg tablet once daily for at least 6 months. intervention 2: Dose-matched oral placebo to MK-5442 intervention 3: Vitamin D3, two 400 IU tablets daily throughout the study. intervention 4: Participants who had a calcium intake of less than 1200 mg/day at baseline received a daily 500 mg calcium supplement throughout the study.

Protocol document: