Fracture Recovery for Returning to Duty (Teriparatide STRONG)

Conditions

• Stress Fracture of Tibia or Fibula

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Teriparatide — DRUG
  Teriparatide, an injectable synthetic parathyroid hormone, will be tested to evaluate its efficacy for decreasing the convalescence after a diaphyseal tibial stress fracture, a specific bone stress injury.
• Placebos — DRUG
  Placebo will be a sugar solution of the manufacturer's design.

Study Details

The project goals are to improve combat readiness of U.S. Soldiers and sustain the availability of the military to deploy by, 1) decreasing the number of days not physically ready for duty after diagnosis of a diaphyseal tibial stress fracture, 2) decreasing the need for a physical profile or medical discharge board after bone stress injury, and 3) decreasing the recurrence rates of bone stress injuries.

Key Dates

Start date

Dec 8, 2022

Status verified

Feb 2023

Primary completion

Dec 30, 2026

Completion

Dec 30, 2026

Study Design

Enrollment

183 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Teriparatide
  Study participants will be randomized into either the study medication arm or a placebo arm. The study medication Forteo (teriparatide \[rDNA origin\] injection) (El-Lilly, Indiana, USA), will be administered via an blinded injection pen in the abdominal wall or thigh as described in the product guide. Subjects in the teriparatide arm will receive a 20mg dose of the medication daily via self-injection.
• Placebo Comparator: Placebo
  The placebo will be administered in a replica, blinded, injection pen in the same fashion. The study participant will self-administer the medication after being given a teaching session on medication administration by the study nurse.

Primary Outcome Measure

Time from diagnosis to full return to activity [ Time Frame: 3 years ]

Locations (1)

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