Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing (STARTT)

Amgen

Status and phase: Completed; Phase 2

Conditions: Fracture Healing

Treatments: Biological: Romosozumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00907296

20062017

2008-008392-34 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 402 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Skeletally mature adults, age 18 to 85 years with radiographically closed growth plates
• Fresh unilateral closed or Gustilo type I or type II open tibial fracture
• Definitive fracture fixation with reamed (closed and open fractures) or unreamed (open fractures only) intramedullary nailing

Exclusion criteria

• Major polytrauma or significant axial trauma
• Associated lower extremity fracture that will delay subject's ability to bear weight beyond the normal time expected for a tibial shaft fracture
• Use of bone grafts at the time of fracture fixation
• Pathological fracture or metabolic or bone disease
• History of symptomatic spinal stenosis or facial nerve paralysis
• Malignancy within the last 5 years
• Evidence of the following (currently or within the past 5 years): elevated transaminases, significantly impaired renal function, current hyper- or hypocalcaemia
• Use of agents affecting bone metabolism
• Subject refuses to use appropriate methods of contraception

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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402 participants in 10 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received subcutaneous injections of matching placebo on day 1 and at weeks 2, 6, and 12.

Treatment:

Drug: Placebo

Romosozumab 70 mg: 2 Doses

Experimental group

Description:

Participants received subcutaneous injections of 70 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.

Treatment:

Biological: Romosozumab

Romosozumab 70 mg: 3 Doses

Experimental group

Description:

Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.

Treatment:

Biological: Romosozumab

Romosozumab 70 mg: 4 Doses

Experimental group

Description:

Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2, 6, and 12.

Treatment:

Biological: Romosozumab

Romosozumab 140 mg: 2 Doses

Experimental group

Description:

Participants received subcutaneous injections of 140 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.

Treatment:

Biological: Romosozumab

Romosozumab 140 mg: 3 Doses

Experimental group

Description:

Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.

Treatment:

Biological: Romosozumab

Romosozumab 140 mg: 4 Doses

Experimental group

Description:

Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2, 6, and 12.

Treatment:

Biological: Romosozumab

Romosozumab 210 mg: 2 Doses

Experimental group

Description:

Participants received subcutaneous injections of 210 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12.

Treatment:

Biological: Romosozumab

Romosozumab 210 mg: 3 Doses

Experimental group

Description:

Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12.

Treatment:

Biological: Romosozumab

Romosozumab 210 mg: 4 Doses

Experimental group

Description:

Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2, 6, and 12.

Treatment:

Biological: Romosozumab