Conditions: Postmenopausal Osteopenia
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 48
Healthy volunteers: yes

Brief summary:
The primary objective of this study was to assess the safety, tolerability, and immunogenicity potential of romosozumab following multiple subcutaneous (SC) administrations in healthy men and postmenopausal women with low bone mass.

Detailed description:

Arms:
arm 1: Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) for 3 months. arm 2: Participants were randomized to receive romosozumab administered by subcutaneous injection at doses of 1 mg/kg Q2W, 2 mg/kg Q4W, 2 mg/kg Q2W, or 3 mg/kg Q4W for 3 months.

Interventions: intervention 1: Romosozumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection

Protocol document: