Abstract
BackgroundStress fractures are a common and potentially debilitating overuse injury to bone and occur frequently among military recruits and athletes. Recovery from a lower body stress fracture typically requires several weeks of physical rehabilitation. Teriparatide, a recombinant form of the bioactive portion of parathyroid hormone (1–34 amino acids), is used to treat osteoporosis, prevent osteoporotic fractures, and enhance fracture healing due to its net anabolic effect on bone. The study aim is to investigate the effect of teriparatide on stress fracture healing in young, otherwise healthy adults undergoing military training.MethodsIn a two-arm, parallel, prospective, randomised controlled, intention-to-treat trial, Army recruits (n = 136 men and women, 18–40 years) with a magnetic resonance imaging (MRI) diagnosed lower body stress fracture (pelvic girdle, sacrum, coccyx, or lower limb) will be randomised to receive either usual Army standard care, or teriparatide and usual Army standard care. Teriparatide will be self-administered by subcutaneous injections (20 μg/day) for 16 weeks, continuing to 24 weeks where a fracture remains unhealed at week 16. The primary outcome will be the improvement in radiological healing by two grades or more, or reduction to grade zero, 8 weeks after randomisation, assessed using Fredericson grading of MRI by radiologists blind to the randomisation. Secondary outcomes will be time to radiological healing, assessed by MRI at 8, 10, 12, 14, 16, 20 and 24 weeks, until healed; time to clinical healing, assessed using a clinical severity score of injury signs and symptoms; time to discharge from Army physical rehabilitation; pain, assessed by visual analogue scale; health-related quality of life, using the Short Form (36) Health Survey; and adverse events. Exploratory outcomes will include blood and urine biochemistry; bone density and morphology assessed using dual-energy X-ray absorptiometry, peripheral quantitative computed tomography (pQCT), and high-resolution pQCT; physical activity measured using accelerometers; and long-term future fracture rate.DiscussionThis study will evaluate whether teriparatide, in addition to standard care, is more effective for stress fracture healing than standard care alone in Army recruits who have sustained a lower body stress fracture.Trial registrationClinicalTrials.govNCT04196855. Registered on 12 December 2019.
Highlights
Background and rationale {6a} Stress fractures are a common and potentially debilitating overuse injury to bone and are frequently reported among military recruits and athletes [1,2,3,4,5,6]
The aim of the present study is to evaluate the effect of daily teriparatide injections on lower body stress fracture healing in young, otherwise healthy adults undergoing Army training
The RETURN trial will be the first study to investigate the effect of teriparatide on lower body stress fracture healing in young, otherwise healthy men and women
Summary
Background and rationale {6a} Stress fractures are a common and potentially debilitating overuse injury to bone and are frequently reported among military recruits and athletes [1,2,3,4,5,6]. Lower body (i.e. pelvic girdle, sacrum, coccyx, and lower limb) stress fractures require the longest rehabilitation times of all musculoskeletal injuries sustained during Army Infantry training, often exceeding 80 days [2]. The return to training of athletes who have sustained lower body stress fractures takes between 61 and 153 days, on average [6]. Stress fractures are a common and potentially debilitating overuse injury to bone and occur frequently among military recruits and athletes. Recovery from a lower body stress fracture typically requires several weeks of physical rehabilitation. The study aim is to investigate the effect of teriparatide on stress fracture healing in young, otherwise healthy adults undergoing military training
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