Conditions: Osteoporosis
Keywords: Postmenopausal Denosumab
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 45
Healthy volunteers: no

Brief summary:
The primary objective was to evaluate the safety and tolerability of denosumab (AMG 162) after a single subcutaneous administration in Japanese postmenopausal women.

Detailed description:

Arms:
arm 1: Participants received a single subcutaneous injection of placebo to denosumab on day 1. arm 2: Participants received a single subcutaneous dose of denosumab on day 1. Doses included 0.03, 0.1, 0.3, 1.0, and 3.0 mg/kg.

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

Protocol document: