The Role of Recombinant PTH in Human Fracture Healing

Zhang, Dafang; Potty, Anish G.; Vyas, Parth; Lane, Joseph M.

doi:10.1097/bot.0b013e31828e13fe

Cited by 74 publications

(58 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…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: 63%

“…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: 97%

See 2 more Smart Citations

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

View full text Add to dashboard Cite

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 ...

show abstract

Section: Discussioncontrasting

confidence: 63%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

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

View full text Add to dashboard Cite

show abstract

“…Recently, in a double blind randomised placebo controlled study in adult patients with OI, teriparatide showed an improvement in bone mineral density both in the lumbar spine and in the hip, as well as in volumetric bone mineral density in the vertebrae and in vertebral strength estimated after 18 months of treatment (18). Teriparatide has also been reported as a drug adjuvant to bone consolidation, although most of the studies in the literature which reflect its beneficial effects in the development of fracture calluses are experimental or series of cases (19), it not being possible to make a recommendation of its use in this respect, nor to reflect this use in its data sheet. Furthermore, the drug appears to reduce the negative effects the bisphosphonates have on the bone (20), for which reason it has also been recommended in some works as the drug of choice for the treatment of atypical fractures.…”

Section: Discussionmentioning

confidence: 99%

An atypical fracture in male patient with osteogenesis imperfecta

Etxebarría-Foronda

Carpintero

2015

ccmbm

View full text Add to dashboard Cite

SummarySo-called atypical fractures have been related to prolonged treatment with bisphosphonates. Although there remain unanswered questions with respect to their etiology and physiopathology, it does appear to be a causal relationship. There are many references in the literature about this problem in patients in whom these drugs have been used to treat osteoporosis, but few reports in patients who have received this therapy for the management of osteogenesis imperfecta. The Authors describe a case of a young male patient with osteogenesis imperfecta with a number of historical fractures, and who received treatment with these drugs, initially parenterally and subsequently orally, presenting as a complication of the treatment, an atypical diaphyseal femoral fracture. The characteristics of the fracture are consistent with the updated diagnostic criteria of the American Society for Bone and Mineral Research. The clinical case, its treatment, both surgically and metabolically with teriparatide, and its development over a year, are analysed. The case is notable for, on the one hand, the significance of the presence of this type of fracture in a young patient with this disease, and on the other, because of the administration of teriparatide outside its established clinical indications, with twin objectives: to improve the bone structure of the patient's underlying disease, and to counteract the harmful effects which bisphosphonates may have on this bone.

show abstract

“…Peichi et al reported that PTH 1-84 (100 μg daily) accelerated fracture healing of pelvic fractures, as evaluated by CT, and improved functional outcomes such as pain, evaluated using a VAS, and mobility, assessed with a timed up-and-go test, in 65 patients with osteoporosis (22). Recent systematic reviews have indicated that TPTD plays an important role in fracture healing and promotes fracture healing in patients with osteoporosis (23,24). In the present case series, TPTD did not show significant effects on BMD and bone turnover markers evaluated with NTX and BAP.…”

Section: Discussionmentioning

confidence: 99%

Enhanced bone healing and decreased pain in sacral insufficiency fractures after teriparatide treatment: retrospective clinical-based observational study

Kasukawa

Miyakoshi

Ebina

et al. 2017

ccmbm

View full text Add to dashboard Cite

SummaryThe purpose of this retrospective clinical-based observational study was to evaluate the effects of teriparatide (TPTD) on clinical outcomes and radiologic findings of sacral insufficiency fractures (SIFs). Seven elderly women with SIFs received TPTD for at least 6 months. We evaluated the symptoms, pain, and radiological findings. At their initial clinic visit, 86% patients could not walk or sit. Computed tomography (CT) images revealed sacral wing fracture in 6 patients, and bone scintigram showed H-shaped uptake over the bilateral sacral wings in 1 patient. After the treatment, 5 patients could walk. Mean visual analog scale score was significantly lower after (12.9 mm) than before (87.4 mm) TPTD treatment (p < 0.0001). CT images revealed bone union (four patients) and sclerotic changes (three patients) at the fracture sites. Seven elderly women with SIFs had significant improvement in pain and demonstrated bone union or sclerotic changes at fracture sites by TPTD.

show abstract

The Role of Recombinant PTH in Human Fracture Healing

Cited by 74 publications

References 28 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

An atypical fracture in male patient with osteogenesis imperfecta

Enhanced bone healing and decreased pain in sacral insufficiency fractures after teriparatide treatment: retrospective clinical-based observational study

Contact Info

Product

Resources

About