Evidence map›Paper›PMID 34461961›Full record

ArticleTrials2021

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.

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 and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04196855 (Study of Teriparatide in Stress Fracture Healing), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.6field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04196855 phase3unknown statusnot on this map

Study of Teriparatide in Stress Fracture Healing

TypeinterventionalSponsorUniversity of East AngliaRan2019 to 2022Enrolled136ConditionsStress Fracture, Parathyroid HormoneArmsTeriparatide
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Observational
  3. Article
  4. Stress fractures.Archives of endocrinology and metabolism · 2022
    Review
  5. Bone Tissue Engineering in the Treatment of Bone Defects.Pharmaceuticals (Basel, Switzerland) · 2022
    Review
  6. Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Alexander T CarswellNorwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, NR4 7TJ, UK. a.carswell@uea.ac.uk.ORCID http://orcid.org/0000-0002-7922-5549
Katharine G EastmanNorwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, NR4 7TJ, UK.
Anna CaseyArmy Health and Performance Research, British Army Headquarters, Ministry of Defence, Andover, SP11 8HT, UK.
Matthew HammondNorwich Clinical Trials Unit, Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK.
Lee ShepstoneNorwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, NR4 7TJ, UK.
Estelle PayerneNorwich Clinical Trials Unit, Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK.
Andoni P TomsNorwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, NR4 7TJ, UK.
James W MacKayNorwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, NR4 7TJ, UK.
Ann Marie SwartNorwich Clinical Trials Unit, Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK.
Julie P GreevesArmy Health and Performance Research, British Army Headquarters, Ministry of Defence, Andover, SP11 8HT, UK.
William D FraserNorwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, NR4 7TJ, UK.
University of East Anglia · GBMinistry of Defence · GB

Funding

Ministry of Defence ArmyHQ2/00269
6 · The paper itself

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. 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 registrationClinicalTrials.gov NCT04196855 . Registered on 12 December 2019.

Indexed as

Bone Density Conservation AgentsFractures, StressFemaleFracture HealingHumansMaleProspective StudiesQuality of LifeRandomized Controlled Trials as TopicTeriparatideYoung AdultBone Density Conservation AgentsTeriparatideBoneIntention-to-treatMagnetic resonance imagingMilitaryMusculoskeletal injuryParathyroid hormoneProspective randomised controlled trialRehabilitationStress fractureTeriparatide

Identifiers

PMID34461961
PMCPMC8404180
OpenAlexW3197148859

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.