Conditions: Osteoporosis
Keywords: osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 154
Healthy volunteers: no

Brief summary:
The primary objectives of this study include evaluating the dose response of LY2541546 using bone mineral density (BMD) change from baseline as compared to placebo and evaluating the overall safety and tolerability of LY2541546 following multiple subcutaneous administrations in postmenopausal (PMP) women with low BMD. Following the last dose of study drug, participants will be able to participate in a 12 month extension to collect additional safety and efficacy data (no further treatment will be administered during this extension).

Detailed description:

Arms:
arm 1: LY2541546: 180 milligrams (mg) administered subcutaneously every 4 weeks (Q4W) for 52 weeks.

Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks. arm 2: LY2541546: 180 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) for 52 weeks. arm 3: LY2541546: 270 milligrams (mg) LY2541546 administered subcutaneously every 2 weeks (Q2W) for 52 weeks. arm 4: LY2541546: 270 milligrams (mg) administered subcutaneously every 12 weeks (Q12W) for 52 weeks.

Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks. arm 5: Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.

Interventions: intervention 1: LY2541546 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered subcutaneously intervention 2: Administered subcutaneously

Protocol document: