Conditions: Osteoporosis
Keywords: bone mineral density, Ronacaleret teriparatide alendronate, Post-menopausal women, osteoporosis, SB-751689
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 564
Healthy volunteers: no

Brief summary:
This is a 12 month study designed to evaluate the safety and effectiveness of SB-751689 in the treatment of osteoporosis in post-menopausal women, in comparison with 2 active comparators and placebo.

Detailed description:

Arms:
arm 1: All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study arm 2: All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study arm 3: Open-label arm. All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study arm 4: 4 arms, 100mg, 200mg, 300mg, 400mg. All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study.

Interventions: intervention 1: Ronacaleret intervention 2: Teriparatide intervention 3: Alendronate
Intervention descriptions: intervention 1: 100mg, 200mg, 300mg, 400mg intervention 2: PTH (1-34) intervention 3: Bisphosphonate

Protocol document: