Teriparatide injections have no effect on healing of proximal humerus fractures .
This report has been verified
by one or more authors of the
original publication.
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Isto permite o reconhecimento precoce de investigação clinicamente significativa e ajuda os leitores a concentrarem-se nos artigos com maior probabilidade de moldar a prática futura.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(10):23 Acta Orthop. 2016 Feb;87(1):79-8240 postmenopausal females patients with proximal humerus fractures were randomized to receive either daily 20ug injections of parathyroid hormone (PTH 1-34) for 4 weeks or a control treatment with no injections. The primary purpose of this study was to determine whether the use of teriparatide (Forteo) was able to accelerate fracture healing. Function and pain outcomes, as well as the use of opioid analgesics, were also compared. The findings of this study indicated no significant differences in pain, opioid or opioid-like consumption, or physical function between both groups, nor were there any signs of accelerated healing through blinded assessment of radiographs after 7 week follow-up.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Sim = 1
Incerto = 0,5
Não relevante = 0
Não = 0
A Avaliação dos Critérios de Relato avalia a transparência com que os autores relatam as caraterísticas metodológicas e do ensaio na publicação. A avaliação está dividida em cinco categorias que são apresentadas de seguida.
3/4
Randomization
3/4
Outcome Measurements
3/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
O Índice de Fragilidade é uma ferramenta que auxilia na interpretação de achados significativos, fornecendo uma medida de força para um resultado. O Índice de Fragilidade representa o número de eventos consecutivos que precisam de ser adicionados a um resultado dicotómico para que o resultado deixe de ser significativo. Um número pequeno representa um resultado mais fraco e um número grande representa um resultado mais forte.
Porque é que este estudo era necessário agora?
A number of previous research studies have attempted to elucidate a method of accelerating fracture healing and reducing non-unions. Previous therapies that have been investigated include the administration of bisphosphonates, bone morphogenetic proteins (BMPs), and parathyroid hormone (PTH). The use of PTH injections has been reported to be successful in accelerating fracture healing in animals; however, there are a limited number of studies pertaining to the use of PTH injections in humans for fracture healing, thus, warranting the current study.
Qual era a principal questão de investigação?
In post-menopausal females, were teriparatide injections (20ug) efficacious in improving bone healing of proximal humerus fractures when compared to a non-injection control group at up to 3 months? Additionally, did the use of teriparatide injections improve function, pain, and reduce analgesic use when compared to a non-injection control group at up to 3 months?
- Radiologist assumptions were correct for radiological outcomes in 21 of 39 cases, indicating that teriparatide did not provide radiographic signs of enhanced healing according to the authors
- No significant differences were reported between groups for pain at rest at 7 weeks (p=0.4) or at 3 months (p=0.7), for pain during activity at 7 weeks (p=0.5) or at 3 months (p=0.8), or proportion of pain-free individuals at any time point
- No significant differences were reported between groups for medication use, assessed after a median of 18 days of use
- No significant differences were reported between groups for function outcomes as measured with DASH
- One fracture complication was reported in each group
- No adverse events were reported in the control group; however, 6 of 19 patients in the PTH group reported mild adverse events
De que é que me devo lembrar mais?
In the treatment of proximal humerus fractures, no significant differences were reported in terms of opioid consumption, pain, or functional outcomes between patients who received parathyroid hormone injections and individuals without injection. Additionally, the radiographic analysis did not find evidence of accelerated fracture healing in the group that received parathyroid hormone injections. More mild adverse events were reported in the parathyroid hormone injection group compared to the control group.
Como é que isto afectará o tratamento dos meus doentes?
The results of this study suggested that the use of the parathyroid hormone (teriparatide) injections in patients with proximal humerus fractures does not enhance bone healing rates, nor does it improve clinical outcomes compared to controls. The results of this study should be interpreted with caution as the method of radiographic evaluation used was qualitative and non-standardized, making it difficult to draw definitive conclusions regarding the effect of teriparatide on bone healing. Future research should use standardized methods of radiographic evaluation and study the effects of PTH injection in other fracture types.
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