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Teriparatide injections have no effect on healing of proximal humerus fractures
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May 2016
Teriparatide injections have no effect on healing of proximal humerus fractures
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A
PTH 1-34 (teriparatide) may not improve healing in proximal humerus fractures
Acta Orthop. 2016 Feb;87(1):79-82Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
40 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.
Publication Funding Details
+
Funding:
Not Reported
Conflicts:
None disclosed
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)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
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
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
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.
What was the principal research question?
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?
Study Characteristics
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Population:
40 post-menopausal women with proximal humerus fractures between the anatomical and surgical neck were included in this study. Eligible patients had fractures that were not severe enough to warrant operative treatment or fixation with osteosutures, allowing the performance of radiographic analysis (39 completed).
Intervention:
PTH group: daily injections of 20 ug teriparatide (PTH 1-34; Forteo, Eli Lilly and Company) were administered within 10 days after fracture and lasted 4 weeks. (n=20, 19 completed study; Mean age: 67 years [Range: 54 - 82])
Comparison:
Control group: no injections were administered to patients in this group (n=20, 20 completed study; Mean age: 69 years [Range: 54 - 94])
Outcomes:
The primary outcome of this study consisted of radiographic results of fracture healing and callus formation. Two blinded radiologists independently answered the following question: "Assuming that PTH has a positive effect on fracture healing, such as increased callus formation, do you think that this patient received PTH?". Differing outcomes were resolved by consensus. Pain at rest and during activity was assessed using the visual analogue scale (VAS), and function was assessed using the disabilities of the arm, shoulder, and hand (DASH) score.
Methods:
RCT
Time:
Follow-ups were conducted at 7 weeks and finally at 3-months.
What were the important findings?
- 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
What should I remember most?
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.
How will this affect the care of my patients?
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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