Academic Journal
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
| العنوان: | 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 |
|---|---|
| المؤلفون: | 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 |
| المصدر: | Trials, Vol 22, Iss 1, Pp 1-18 (2021) |
| بيانات النشر: | BMC, 2021. |
| سنة النشر: | 2021 |
| المجموعة: | LCC:Medicine (General) |
| مصطلحات موضوعية: | Stress fracture, Bone, Musculoskeletal injury, Teriparatide, Parathyroid hormone, Magnetic resonance imaging, Medicine (General), R5-920 |
| الوصف: | 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. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 1745-6215 |
| Relation: | https://doaj.org/toc/1745-6215 |
| DOI: | 10.1186/s13063-021-05556-3 |
| URL الوصول: | https://doaj.org/article/0a0bf1afedf144459a03c2aefaa733f8 |
| رقم الانضمام: | edsdoj.0a0bf1afedf144459a03c2aefaa733f8 |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | ResultId |
1 |
|---|---|
| Header |
edsdoj Directory of Open Access Journals edsdoj.0a0bf1afedf144459a03c2aefaa733f8 952 3 Academic Journal academicJournal 951.913452148438 |
| PLink |
https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&scope=site&db=edsdoj&AN=edsdoj.0a0bf1afedf144459a03c2aefaa733f8&custid=s6537998&authtype=sso |
| FullText |
Array
(
[Availability] => 0
)
Array ( [0] => Array ( [Url] => https://doaj.org/article/0a0bf1afedf144459a03c2aefaa733f8 [Name] => EDS - DOAJ [Category] => fullText [Text] => View record in DOAJ [MouseOverText] => View record in DOAJ ) [1] => Array ( [Url] => https://resolver.ebscohost.com/openurl?custid=s6537998&groupid=main&authtype=ip,guest&sid=EBSCO:edsdoj&genre=article&issn=17456215&ISBN=&volume=22&issue=1&date=20210801&spage=1&pages=1-18&title=Trials&atitle=Teriparatide%20and%20stress%20fracture%20healing%20in%20young%20adults%20%28RETURN%20%E2%80%93%20Research%20on%20Efficacy%20of%20Teriparatide%20Use%20in%20the%20Return%20of%20recruits%20to%20Normal%20duty%29%3A%20study%20protocol%20for%20a%20randomised%20controlled%20trial&id=DOI:10.1186/s13063-021-05556-3 [Name] => Full Text Finder (s6537998api) [Category] => fullText [Text] => Full Text Finder [Icon] => https://imageserver.ebscohost.com/branding/images/FTF.gif [MouseOverText] => Full Text Finder ) ) |
| Items |
Array
(
[Name] => Title
[Label] => Title
[Group] => Ti
[Data] => 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
)
Array ( [Name] => Author [Label] => Authors [Group] => Au [Data] => <searchLink fieldCode="AR" term="%22Alexander+T%2E+Carswell%22">Alexander T. Carswell</searchLink><br /><searchLink fieldCode="AR" term="%22Katharine+G%2E+Eastman%22">Katharine G. Eastman</searchLink><br /><searchLink fieldCode="AR" term="%22Anna+Casey%22">Anna Casey</searchLink><br /><searchLink fieldCode="AR" term="%22Matthew+Hammond%22">Matthew Hammond</searchLink><br /><searchLink fieldCode="AR" term="%22Lee+Shepstone%22">Lee Shepstone</searchLink><br /><searchLink fieldCode="AR" term="%22Estelle+Payerne%22">Estelle Payerne</searchLink><br /><searchLink fieldCode="AR" term="%22Andoni+P%2E+Toms%22">Andoni P. Toms</searchLink><br /><searchLink fieldCode="AR" term="%22James+W%2E+MacKay%22">James W. MacKay</searchLink><br /><searchLink fieldCode="AR" term="%22Ann+Marie+Swart%22">Ann Marie Swart</searchLink><br /><searchLink fieldCode="AR" term="%22Julie+P%2E+Greeves%22">Julie P. Greeves</searchLink><br /><searchLink fieldCode="AR" term="%22William+D%2E+Fraser%22">William D. Fraser</searchLink> ) Array ( [Name] => TitleSource [Label] => Source [Group] => Src [Data] => Trials, Vol 22, Iss 1, Pp 1-18 (2021) ) Array ( [Name] => Publisher [Label] => Publisher Information [Group] => PubInfo [Data] => BMC, 2021. ) Array ( [Name] => DatePubCY [Label] => Publication Year [Group] => Date [Data] => 2021 ) Array ( [Name] => Subset [Label] => Collection [Group] => HoldingsInfo [Data] => LCC:Medicine (General) ) Array ( [Name] => Subject [Label] => Subject Terms [Group] => Su [Data] => <searchLink fieldCode="DE" term="%22Stress+fracture%22">Stress fracture</searchLink><br /><searchLink fieldCode="DE" term="%22Bone%22">Bone</searchLink><br /><searchLink fieldCode="DE" term="%22Musculoskeletal+injury%22">Musculoskeletal injury</searchLink><br /><searchLink fieldCode="DE" term="%22Teriparatide%22">Teriparatide</searchLink><br /><searchLink fieldCode="DE" term="%22Parathyroid+hormone%22">Parathyroid hormone</searchLink><br /><searchLink fieldCode="DE" term="%22Magnetic+resonance+imaging%22">Magnetic resonance imaging</searchLink><br /><searchLink fieldCode="DE" term="%22Medicine+%28General%29%22">Medicine (General)</searchLink><br /><searchLink fieldCode="DE" term="%22R5-920%22">R5-920</searchLink> ) Array ( [Name] => Abstract [Label] => Description [Group] => Ab [Data] => 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. ) Array ( [Name] => TypeDocument [Label] => Document Type [Group] => TypDoc [Data] => article ) Array ( [Name] => Format [Label] => File Description [Group] => SrcInfo [Data] => electronic resource ) Array ( [Name] => Language [Label] => Language [Group] => Lang [Data] => English ) Array ( [Name] => ISSN [Label] => ISSN [Group] => ISSN [Data] => 1745-6215 ) Array ( [Name] => NoteTitleSource [Label] => Relation [Group] => SrcInfo [Data] => https://doaj.org/toc/1745-6215 ) Array ( [Name] => DOI [Label] => DOI [Group] => ID [Data] => 10.1186/s13063-021-05556-3 ) Array ( [Name] => URL [Label] => Access URL [Group] => URL [Data] => <link linkTarget="URL" linkTerm="https://doaj.org/article/0a0bf1afedf144459a03c2aefaa733f8" linkWindow="_blank">https://doaj.org/article/0a0bf1afedf144459a03c2aefaa733f8</link> ) Array ( [Name] => AN [Label] => Accession Number [Group] => ID [Data] => edsdoj.0a0bf1afedf144459a03c2aefaa733f8 ) |
| RecordInfo |
Array
(
[BibEntity] => Array
(
[Identifiers] => Array
(
[0] => Array
(
[Type] => doi
[Value] => 10.1186/s13063-021-05556-3
)
)
[Languages] => Array
(
[0] => Array
(
[Text] => English
)
)
[PhysicalDescription] => Array
(
[Pagination] => Array
(
[PageCount] => 18
[StartPage] => 1
)
)
[Subjects] => Array
(
[0] => Array
(
[SubjectFull] => Stress fracture
[Type] => general
)
[1] => Array
(
[SubjectFull] => Bone
[Type] => general
)
[2] => Array
(
[SubjectFull] => Musculoskeletal injury
[Type] => general
)
[3] => Array
(
[SubjectFull] => Teriparatide
[Type] => general
)
[4] => Array
(
[SubjectFull] => Parathyroid hormone
[Type] => general
)
[5] => Array
(
[SubjectFull] => Magnetic resonance imaging
[Type] => general
)
[6] => Array
(
[SubjectFull] => Medicine (General)
[Type] => general
)
[7] => Array
(
[SubjectFull] => R5-920
[Type] => general
)
)
[Titles] => Array
(
[0] => Array
(
[TitleFull] => 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
[Type] => main
)
)
)
[BibRelationships] => Array
(
[HasContributorRelationships] => Array
(
[0] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Alexander T. Carswell
)
)
)
[1] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Katharine G. Eastman
)
)
)
[2] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Anna Casey
)
)
)
[3] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Matthew Hammond
)
)
)
[4] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Lee Shepstone
)
)
)
[5] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Estelle Payerne
)
)
)
[6] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Andoni P. Toms
)
)
)
[7] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => James W. MacKay
)
)
)
[8] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Ann Marie Swart
)
)
)
[9] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Julie P. Greeves
)
)
)
[10] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => William D. Fraser
)
)
)
)
[IsPartOfRelationships] => Array
(
[0] => Array
(
[BibEntity] => Array
(
[Dates] => Array
(
[0] => Array
(
[D] => 01
[M] => 08
[Type] => published
[Y] => 2021
)
)
[Identifiers] => Array
(
[0] => Array
(
[Type] => issn-print
[Value] => 17456215
)
)
[Numbering] => Array
(
[0] => Array
(
[Type] => volume
[Value] => 22
)
[1] => Array
(
[Type] => issue
[Value] => 1
)
)
[Titles] => Array
(
[0] => Array
(
[TitleFull] => Trials
[Type] => main
)
)
)
)
)
)
)
|
| IllustrationInfo |