Scientific Title:

Research on Efficacy of Teriparatide Use in the Return of recruits to Normal duty

Chief Investigator:

Professor William Fraser

Funder:

The Ministry of Defence (MOD)

Sponsor:

Norfolk and Norwich University Hospitals NHS Foundation Trust

Health Condition or Problem Studied:

Military recruits presenting with a lower body stress fracture, as confirmed via Magnetic Resonance Imaging (MRI).

Intervention:

• Control Arm: Standard care only. Participants will undergo standard care with a personalised rehabilitation plan, according to routine military training care. Participants will be required to adhere to the standard care assessments regimen for 16 weeks. Assessments will be extended to 24 weeks if the fracture is unhealed at 16 weeks.

• Active Arm: Standard care and Teriparatide Subcutaneous Injections. In addition to standard care, participants in the active arm will self-administer teriparatide via subcutaneous injection using a reusable Terrosa pen fitted with a Terrosa cartridge. Injections will be required once a day, at the same time of day.

Study Design:

This is an open label, intention to treat, randomised controlled trial (RCT) of parathyroid hormone versus standard care.

Target Sample Size:

136, 68 in each arm. A sub-group of a minimum of 20 participants (10 in each arm) will be asked to wear a wrist-mounted tri-axial accelerometer (GENEActiv, Activinsights, Kimbolton, UK) to monitor physical activity levels throughout the trial.

Status:

Recruiting