Effect of Intermittent Systemic Administration of Recombinant Parathyroid Hormone (1-34) on Mandibular Fracture Healing in Rats

Rowshan, Henry H.; Parham, Mary A.; Baur, Dale A.; McEntee, RaeLynn D.; Cauley, Eugene; Carriere, Dane T.; Wood, Jo; Demsar, William J.; Pizarro, José María Sánchez-Marín

doi:10.1016/j.joms.2009.09.045

Cited by 51 publications

(41 citation statements)

References 31 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: 54%

“…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%

“…Teriparatide (recombinant human parathyroid hormone [PTH] ; Forteo 1 / Forsteo 1 , Eli Lilly and Company, Indianapolis, IN, USA) is approved for treating osteoporosis and glucocorticoid-induced osteoporosis in patients at high fracture risk [12,29]. Teriparatide enhanced bone healing in preclinical models [1,20,28,32], and in a controlled clinical trial accelerated radiographic healing of wrist fractures at a dosage of 20 lg/day (post hoc analysis) but not 40 lg/day (primary endpoint) [2]. PTH 1-84 also improved fracture healing in a controlled trial of patients with pelvic fractures [30].…”

Section: Introductionmentioning

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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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: 54%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

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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“…25 The measurement of BMD by radiographic densitometry has been performed in a number of studies, and its efficacy has been confirmed. 1,4,7,26 Radiographic densitometry may be considered as a minimally invasive and convenient method for diagnosing osteoporosis. 1 According to Erdogan et al, 1 the radiological parameters can facilitate the establishment of a definite diagnosis of osteoporosis.…”

Section: Discussionmentioning

confidence: 99%

Radiodensitometric and DXA analyses for the measurement of bone mineral density after systemic alendronate therapy

Lucisano

Filho

Morse³

et al. 2013

Braz. oral res.

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Precise techniques for the measurement of maxillary bone mineral density (BMD) are useful for the early diagnosis of systemic diseases. The aim of this study was to compare in vivo the efficacy of dualenergy x-ray absorptiometry (DXA) and radiographic densitometry for the measurement of BMD after systemic administration of sodium alendronate. Wistar rats were randomly allocated to a control group (n = 5), which received distilled water, and a sodium alendronate group (n = 8), which received two doses of chemically pure sodium alendronate (1 mg/ kg) per week. After 8 weeks, the animals were euthanized, the tibias were removed, and the BMD of the proximal tibial metaphysis was analyzed radiographically and by DXA. The data were subjected to statistical analysis by the Kruskal-Wallis test at a significance level of 5%. Both of the techniques revealed that the alendronate-treated group had a significantly higher BMD (p < 0.05) than the control group after 8 weeks of treatment. Comparing the groups with and without alendronate therapy revealed increases of 14.9% and 29.6% in BMD, as detected radiographically and by DXA, respectively. In conclusion, both of the methods were able to detect an increase in BMD of the proximal tibial metaphysis after alendronate therapy.

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“…Recently, interests in its clinical application have emerged for bone regeneration in localized osseous defects and fractures (Skripitz et al, 2000;Barnes et al, 2008;Bashutski et al, 2010). Animal models with/without induced osteoporosis and gene ablation models support the impact of PTH on bone development and remodeling in the craniofacial region, thus providing a sound rationale for the use of PTH for applications in oral and maxillofacial bone regeneration (Kawane et al, 2002;Rowshan et al, 2010;Valderrama et al, 2010). Preliminary clinical studies have shown promising results with teriparatide for periodontal regeneration and the treatment of osteonecrosis of the jaw related to the use of bone antiresorptive drugs (Tsai et al, 2010;Lee et al, 2011;Kwon et al, 2012).…”

Section: Introduction Tmentioning

confidence: 99%

Parathyroid Hormone Applications in the Craniofacial Skeleton

Chan

McCauley

2012

J Dent Res

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Parathyroid hormone (PTH) is known for its ability to ‘build’ bone, with research in this area centered on its use as an osteoporosis therapeutic. Recent interest has developed regarding its potential for regenerative applications such as fracture healing and osseous defects of the oral cavity. Many years of investigation using murine gene-targeted models substantiate a role for signaling at the PTH/PTH-related protein (PTHrP) receptor (PPR) in intramembranous bone formation in the craniofacial region as well as in tooth development. Pre-clinical studies clearly support a positive role of intermittent PTH administration in craniofacial bones and in fracture healing and implant integration. A few human clinical studies have shown favorable responses with teriparatide (the biologically active fragment of PTH) administration. Favorable outcomes have emerged with teriparatide administration in patients with osteonecrosis of the jaw (ONJ). New delivery strategies are in development to optimize targeted application of PTH and to help maximize local approaches. The promising host-modulating potential of PTH requires more information to further its effectiveness for craniofacial regeneration and osseous wound-healing, including a better delineation of cellular targets, temporal effects of PTH action, and improved approaches for local/targeted delivery of PTH.

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Effect of Intermittent Systemic Administration of Recombinant Parathyroid Hormone (1-34) on Mandibular Fracture Healing in Rats

Cited by 51 publications

References 31 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

Radiodensitometric and DXA analyses for the measurement of bone mineral density after systemic alendronate therapy

Parathyroid Hormone Applications in the Craniofacial Skeleton

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