Teriparatide and stress fracture healing in young adults (RETURN – Research on Efficacy of Teriparatide Use in the Return of recruits to Normal duty): study protocol for a randomised controlled trial

Abstract Background Stress fractures are a common and potentially debilitating overuse injury to bone occur frequently among military recruits athletes. Recovery from lower body stress fracture typically requires several weeks of physical rehabilitation. Teriparatide, recombinant form the bioactive portion parathyroid hormone (1–34 amino acids), is used treat osteoporosis, prevent osteoporotic fractures, enhance healing due its net anabolic effect on bone. The study aim investigate teriparatide in young, otherwise healthy adults undergoing training. Methods In two-arm, parallel, prospective, randomised controlled, intention-to-treat trial, Army ( n = 136 men women, 18–40 years) with magnetic resonance imaging (MRI) diagnosed (pelvic girdle, sacrum, coccyx, or limb) will be receive either usual standard care, care. Teriparatide self-administered by subcutaneous injections (20 μg/day) for 16 weeks, continuing 24 where remains unhealed at week 16. primary outcome improvement radiological two grades more, reduction grade zero, 8 after randomisation, assessed using Fredericson grading MRI radiologists blind randomisation. Secondary outcomes time healing, 8, 10, 12, 14, 16, 20 until healed; clinical severity score signs symptoms; discharge rehabilitation; pain, visual analogue scale; health-related quality life, Short Form (36) Health Survey; adverse events. Exploratory include blood urine biochemistry; density morphology dual-energy X-ray absorptiometry, peripheral quantitative computed tomography (pQCT), high-resolution pQCT; activity measured accelerometers; long-term future rate. Discussion This evaluate whether teriparatide, addition more effective than care alone who have sustained fracture. Trial registration ClinicalTrials.gov NCT04196855 . Registered 12 December 2019.