Successful treatment of sternal fracture nonunion with teriparatide

Chintamaneni, Sreekanth; Finzel, Kathleen C.; Gruber, Barbara

doi:10.1007/s00198-009-1061-4

Cited by 91 publications

(52 citation statements)

References 13 publications

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“…The study also is one of only a few well-controlled studies of clinical outcomes with a systemically active biologic drug in patients with fracture. Although preclinical studies using PTH in animal models are promising [1,20,28,32] and sporadic case reports of humans [8,19,31,33,37,38] showed an anecdotal benefit of teriparatide in various fractures, there were no well-controlled clinical trials to support the hypothesis that teriparatide improve fracture healing and our study with a much-reduced sample size showed no such benefit. Thus, the effect of teriparatide on fracture healing remains uncertain.…”

Section: Discussioncontrasting

confidence: 57%

“…Systemic therapy with teriparatide has been shown to improve healing in preclinical fracture models [1,20,28,32], in clinical studies of wrist fractures [2], and in case reports [8,19,31,33,37,38]. However, the results from these pooled trials revealed no treatment effect of teriparatide versus placebo in the rates of revision surgery or radiographic fracture healing in femoral neck fractures.…”

Section: Discussionmentioning

confidence: 99%

“…PTH 1-84 also improved fracture healing in a controlled trial of patients with pelvic fractures [30]. Published case reports suggest that teriparatide accelerates bone healing and improves functional recovery after fracture at various skeletal sites [8,19,31,33,37,38].…”

Section: Introductionmentioning

confidence: 95%

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Does Teriparatide Improve Femoral Neck Fracture Healing: Results From A Randomized Placebo-controlled Trial

Bhandari

Jin

See

et al. 2016

Clinical Orthopaedics &Amp; Related Research

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Background There is a medical need for therapies that improve hip fracture healing. Teriparatide (Forteo 1 / Forsteo 1 , recombinant human parathyroid hormone) is a bone anabolic drug that is approved for treatment of osteoporosis and glucocorticoid-induced osteoporosis in men and postmenopausal women at high fracture risk. Preclinical and preliminary clinical data also suggest that teriparatide may enhance bone healing.Questions/purposes We wished to test the hypotheses that treatment with teriparatide versus placebo would improve femoral neck fracture healing after internal fixation as measured by (1) frequency of revision surgery, (2) radiographic fracture healing, and (3) other outcomes including pain control, gait speed, and safety. Methods We initiated two separate, but identically designed, clinical trials to meet FDA requirements to provide substantial evidence to support approval of a new indication. The two prospective, randomized double-blind, placebo-controlled Phase III studies were designed to evaluate the effect of subcutaneous teriparatide (20 lg/day) for 6 months versus placebo on fracture healing at 24 months. The trials were conducted concurrently with a planned enrollment of 1220 patients per trial. However, enrollment was stopped owing to very slow patient accrual, and an a priori decision was made to pool the results of those studies for statistical analyses before study completion; pooling was specified in both protocols. Randomization was stratified by fixation (sliding hip screw or multiple cancellous screws) and fracture type (displaced or nondisplaced). An independent Central Adjudication Committee reviewed revision surgical procedures and radiographs. A total of 159 patients were randomized in the two trials (81 placebo, 78 teriparatide). The combined program had very low power to detect the originally This study was sponsored by Eli Lilly and Company. The institutions of authors (MB, NG, RW) have received, during the study period, funding from Eli Lilly and Company. One author (MB), or a member of his or her immediate family, has or may receive payments or benefits, during the study period, an amount of less than USD 10,000 from Eli Lilly and Company. One or more of the authors (LJ, KS, RB, KDK, MRW, BM) are employees of Eli Lilly and Company, that provided funding for this study. One of the authors (QIA) was an employee of Eli Lilly and Company at the time of the study but he no longer is employed by them. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research 1 editors and board members are on file with the publication and can be viewed on request. Each author certifies that his or her institution approved the human protocol for this investigation, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained. This study was conducted at the authors' various institutions. Clinical Orthopaedics and Related Research ®A Publication of The ...

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Section: Discussioncontrasting

confidence: 57%

Section: Discussionmentioning

confidence: 99%

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Does Teriparatide Improve Femoral Neck Fracture Healing: Results From A Randomized Placebo-controlled Trial

Bhandari

Jin

See

et al. 2016

Clinical Orthopaedics &Amp; Related Research

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“…A few case reports and anecdotal findings suggest that teriparatide therapy can improve or hasten healing of these fractures. (13,123) Additionally, consistent with a large body of animal data, (166) some clinical evidence (167,168) indicates that teriparatide benefits nonunion of fractures, although a controlled trial in patients with Colles' fracture showed little effect. (169) Given the relative rarity of atypical femoral fractures and ethical issues surrounding potential randomization to placebo, it seems unlikely that there will be a randomized, controlled trial of teriparatide for subtrochanteric and femoral shaft fractures.…”

Section: Medical Management Of Atypical Subtrochanteric/femoral Shaftmentioning

confidence: 77%

Atypical subtrochanteric and diaphyseal femoral fractures: Report of a task force of the american society for bone and mineral Research

Shane

Burr

Ebeling

et al. 2010

Journal of Bone and Mineral Research

970

651

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Reports linking long-term use of bisphosphonates (BPs) with atypical fractures of the femur led the leadership of the American Society for Bone and Mineral Research (ASBMR) to appoint a task force to address key questions related to this problem. A multidisciplinary expert group reviewed pertinent published reports concerning atypical femur fractures, as well as preclinical studies that could provide insight into their pathogenesis. A case definition was developed so that subsequent studies report on the same condition. The task force defined major and minor features of complete and incomplete atypical femoral fractures and recommends that all major features, including their location in the subtrochanteric region and femoral shaft, transverse or short oblique orientation, minimal or no associated trauma, a medial spike when the fracture is complete, and absence of comminution, be present to designate a femoral fracture as atypical. Minor features include their association with cortical thickening, a periosteal reaction of the lateral cortex, prodromal pain, bilaterality, delayed healing, comorbid conditions, and concomitant drug exposures, including BPs, other antiresorptive agents, glucocorticoids, and proton pump inhibitors. Preclinical data evaluating the effects of BPs on collagen cross-linking and maturation, accumulation of microdamage and advanced glycation end products, mineralization, remodeling, vascularity, and angiogenesis lend biologic plausibility to a potential association with long-term BP use. Based on published and unpublished data and the widespread use of BPs, the incidence of atypical femoral fractures associated with BP therapy for osteoporosis appears to be very low, particularly compared with the number of vertebral, hip, and other fractures that are prevented by BPs. Moreover, a causal association between BPs and atypical fractures has not been established. However, recent observations suggest that the risk rises with increasing duration of exposure, and there is concern that lack of awareness and underreporting may mask the true incidence of the problem. Given the relative rarity of atypical femoral fractures, the task force recommends that specific diagnostic and procedural codes be created and that an international registry be established to facilitate studies of the clinical and genetic risk factors and optimal surgical and medical management of these fractures. Physicians and patients should be made aware of the possibility of atypical femoral fractures and of the potential for bilaterality through a change in labeling of BPs. Research directions should include development of animal models, increased surveillance, and additional epidemiologic and clinical data to establish the true incidence of and risk factors for this condition and to inform orthopedic and medical management. ß

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“…7 Chintamaneni et al described the first case of sternal fracture nonunion responding to treatment with teriparatide, with dramatic radiographic healing more than 6 months after the initial fracture. 8 Another study showed a patient with delayed union of a humeral shaft fracture healed after 5 months of therapy with teriparatide, without other interventions. 9 Resmini et al described a 79-year-old osteoporotic lady already on teriparatide treatment who sustained a fracture of the left proximal humerus.…”

Section: Discussionmentioning

confidence: 99%

Successful treatment of nonuniting fracture ICNF with Teriparatide in young adult osteopenic male

Kundu¹

2018

Int J Res Orthop

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<p class="abstract"><span lang="EN-IN">We present a case of fracture intra capsular neck of femur in a young adult osteopenic patient, who had a nonunion and early signs of avascular necrosis even after the initial surgical intervention. Teriparatide was administered for two monthly doses after diagnosis of nonunion and avascular necrosis of femoral neck. 90% successful union was achieved in 2 months without further surgical intervention, and no adverse events related to the use of teriparatide were observed. Our case report shows that teriparatide can be an alternative to surgical intervention in nonunion of ICNF with early signs of avascular necrosis.</span></p>

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Successful treatment of sternal fracture nonunion with teriparatide

Cited by 91 publications

References 13 publications

Does Teriparatide Improve Femoral Neck Fracture Healing: Results From A Randomized Placebo-controlled Trial

Does Teriparatide Improve Femoral Neck Fracture Healing: Results From A Randomized Placebo-controlled Trial

Atypical subtrochanteric and diaphyseal femoral fractures: Report of a task force of the american society for bone and mineral Research

Successful treatment of nonuniting fracture ICNF with Teriparatide in young adult osteopenic male

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