Conditions: Fracture Healing
Keywords: Fracture Healing Tibial Diaphyseal Fracture
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 402
Healthy volunteers: no

Brief summary:
The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).

Detailed description:

Arms:
arm 1: Participants received subcutaneous injections of matching placebo on day 1 and at weeks 2, 6, and 12. arm 2: Participants received subcutaneous injections of 70 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12. arm 3: Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12. arm 4: Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2, 6, and 12. arm 5: Participants received subcutaneous injections of 140 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12. arm 6: Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12. arm 7: Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2, 6, and 12. arm 8: Participants received subcutaneous injections of 210 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12. arm 9: Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12. arm 10: Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2, 6, and 12.

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

Protocol document: