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 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...
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| Format: | Article |
| Language: | English |
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BMC
2021-08-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05556-3 |
| _version_ | 1828961625297649664 |
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| author | Alexander T. Carswell Katharine G. Eastman Anna Casey Matthew Hammond Lee Shepstone Estelle Payerne Andoni P. Toms James W. MacKay Ann Marie Swart Julie P. Greeves William D. Fraser |
| author_facet | Alexander T. Carswell Katharine G. Eastman Anna Casey Matthew Hammond Lee Shepstone Estelle Payerne Andoni P. Toms James W. MacKay Ann Marie Swart Julie P. Greeves William D. Fraser |
| author_sort | Alexander T. Carswell |
| collection | DOAJ |
| description | 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.gov NCT04196855 . Registered on 12 December 2019. |
| first_indexed | 2024-12-14T09:49:56Z |
| format | Article |
| id | doaj.art-0a0bf1afedf144459a03c2aefaa733f8 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-14T09:49:56Z |
| publishDate | 2021-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-0a0bf1afedf144459a03c2aefaa733f82022-12-21T23:07:33ZengBMCTrials1745-62152021-08-0122111810.1186/s13063-021-05556-3Teriparatide 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 trialAlexander T. Carswell0Katharine G. Eastman1Anna Casey2Matthew Hammond3Lee Shepstone4Estelle Payerne5Andoni P. Toms6James W. MacKay7Ann Marie Swart8Julie P. Greeves9William D. Fraser10Norwich Medical School, Faculty of Medicine and Health Sciences, University of East AngliaNorwich Medical School, Faculty of Medicine and Health Sciences, University of East AngliaArmy Health and Performance Research, British Army Headquarters, Ministry of DefenceNorwich Clinical Trials Unit, Norwich Medical School, University of East AngliaNorwich Medical School, Faculty of Medicine and Health Sciences, University of East AngliaNorwich Clinical Trials Unit, Norwich Medical School, University of East AngliaNorwich Medical School, Faculty of Medicine and Health Sciences, University of East AngliaNorwich Medical School, Faculty of Medicine and Health Sciences, University of East AngliaNorwich Clinical Trials Unit, Norwich Medical School, University of East AngliaArmy Health and Performance Research, British Army Headquarters, Ministry of DefenceNorwich Medical School, Faculty of Medicine and Health Sciences, University of East AngliaAbstract 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.gov NCT04196855 . Registered on 12 December 2019.https://doi.org/10.1186/s13063-021-05556-3Stress fractureBoneMusculoskeletal injuryTeriparatideParathyroid hormoneMagnetic resonance imaging |
| spellingShingle | Alexander T. Carswell Katharine G. Eastman Anna Casey Matthew Hammond Lee Shepstone Estelle Payerne Andoni P. Toms James W. MacKay Ann Marie Swart Julie P. Greeves William D. Fraser 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 Stress fracture Bone Musculoskeletal injury Teriparatide Parathyroid hormone Magnetic resonance imaging |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Stress fracture Bone Musculoskeletal injury Teriparatide Parathyroid hormone Magnetic resonance imaging |
| url | https://doi.org/10.1186/s13063-021-05556-3 |
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