Study To Assess FRacTure Healing With SclerosTin Antibody - Hip (STARTT-Hip)

Amgen

Status and phase: Completed; Phase 2

Conditions: Fracture Healing

Treatments: Drug: Placebo; Drug: Romosozumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01081678

20080394

Details and patient eligibility

About

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.

Enrollment: 332 patients

Sex: All

Ages: 55 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females, age 55 to 95 years

• fresh unilateral low energy intertrochanteric or femoral neck fracture as the primary injury, confirmed by X-ray and in the opinion of the treating surgeon amenable to repair by internal fixation

• internal fixation of the fracture with devices approved by local regulatory agency, performed no later than 7 days after injury for intertrochanteric or undisplaced femoral neck fractures and no later than 2 days after injury for displaced femoral neck fractures

  • intertrochanteric fracture: sliding hip screw or IM nail
  • femoral neck fracture: sliding hip screw or at least 3 cancellous screws

Exclusion criteria

• severe symptomatic osteoarthritis of the lower extremity
• inability to independently rise from armchair or walk 200 meters before hip fracture
• presence of concomitant injuries such as rib fractures, wrist fractures, or acute symptomatic vertebral fractures which severely impair the ability to rise from a chair
• associated extremity injuries including ipsilateral or contralateral fractures of the foot, tibia or fibula, wrist, humerus, femoral shaft, femoral head or hip dislocation, that may delay weight-bearing beyond one week after surgery
• head-injury, as defined by Glasgow Coma Scale < 13 prior to randomization
• use of bone grafts or bone substitutes at the time of fracture fixation
• major polytrauma or significant axial trauma, with Injury Severity Score > 16
• pathological fracture or history of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as Paget's disease, rheumatoid arthritis, osteomalacia, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia
• history of symptomatic spinal stenosis that has not been surgically corrected. If surgically corrected, the subject must be asymptomatic to be eligible for the study.
• history of facial nerve paralysis
• malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical carcinoma in situ) within the last 5 years
• history of solid organ or bone marrow transplants
• evidence of elevated transaminases (≥ 2.0 x upper limits of normal) or significantly impaired renal function (creatinine clearance of ≤ 30 mL/min)
• evidence of current hypercalcemia or hypocalcemia (outside of 1.1 x the normal range)
• bone morphogenic proteins (BMP)-2 or BMP-7 at the time of definitive fracture fixation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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332 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.

Treatment:

Drug: Placebo

Romosozumab 70 mg

Experimental group

Description:

Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.

Treatment:

Drug: Romosozumab

Romosozumab 140 mg

Experimental group

Description:

Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.

Treatment:

Drug: Romosozumab

Romosozumab 210 mg

Experimental group

Description:

Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.

Treatment:

Drug: Romosozumab