Conditions: Fracture Healing
Keywords: AMG 785 Proximal Femur Fracture Healing Hip Fracture
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 332
Healthy volunteers: no

Brief summary:
This is an international, multi-center study to determine the efficacy, safety, and tolerability of romosozumab (AMG 785) in adults with a fresh unilateral hip fracture, status post surgical fixation.

Detailed description:

Arms:
arm 1: Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12. arm 2: Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12. arm 3: Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12. arm 4: Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.

Interventions: intervention 1: Placebo intervention 2: Romosozumab
Intervention descriptions: intervention 1: Administered by subcutaneous (under the skin) injection intervention 2: Administered by subcutaneous injection

Protocol document: