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

Carswell, Alexander T., Eastman, Katharine G., Casey, Anna, Hammond, Matthew, Shepstone, Lee, Payerne, Estelle, Toms, Andoni P., MacKay, James W., Swart, Ann Marie, Greeves, Julie P. and Fraser, William D. (2021) 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. Trials, 22 (1). ISSN 1745-6215

[img] PDF (Published_Version) - Published Version
Available under License Creative Commons Attribution.

Download (1MB)

Abstract

Background: 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. 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. Methods: In 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. Discussion: This 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 registration: ClinicalTrials.govNCT04196855. Registered on 12 December 2019.

Item Type: Article
Uncontrolled Keywords: bone,intention-to-treat,magnetic resonance imaging,military,musculoskeletal injury,parathyroid hormone,prospective randomised controlled trial,rehabilitation,stress fracture,teriparatide,medicine (miscellaneous),pharmacology (medical) ,/dk/atira/pure/subjectarea/asjc/2700/2701
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
Related URLs:
Depositing User: LivePure Connector
Date Deposited: 02 Sep 2021 00:18
Last Modified: 16 Sep 2021 11:14
URI: https://ueaeprints.uea.ac.uk/id/eprint/81276
DOI: 10.1186/s13063-021-05556-3

Actions (login required)

View Item View Item