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1.
Medicine (Baltimore) ; 99(5): e18989, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32000434

RESUMO

RATIONALE: Although the treatment of femoral head necrosis has already been established with the adoption of daily teriparatide, a clear consensus on the treatment of spontaneous osteonecrosis of the knee (SONK) has yet to be reached. Therefore, we focused on the treatment of SONK with daily teriparatide administration (20 µg, subcutaneous) and confirmed its effects to determine whether it is a valid option. PATIENTS' CONCERNS: Three osteoporotic patients who were diagnosed with SONK complained of knee pain. DIAGNOSIS: SONK was diagnosed on magnetic resonance imaging in all cases. INTERVENTIONS: All patients took daily teriparatide as a treatment for SONK. OUTCOMES: There was a significant and dramatic reduction in the visual analog scale score 1 month after treatment. After 6 months of treatment, the sizes of the affected SONK lesions were smaller than in the initial phase, and plain X-rays showed no further signs of progression. LESSONS: Daily teriparatide might be an effective treatment for SONK.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Articulação do Joelho , Osteonecrose/tratamento farmacológico , Teriparatida/uso terapêutico , Idoso , Biomarcadores/sangue , Densidade Óssea , Feminino , Humanos , Imagem por Ressonância Magnética , Masculino , Osteonecrose/diagnóstico por imagem , Medição da Dor , Teriparatida/administração & dosagem
2.
J Bone Miner Metab ; 38(1): 44-53, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31297652

RESUMO

The objective of the present multicenter randomized study was to compare weekly teriparatide with alendronate in their inhibition of vertebral collapse, effects on delayed union, pain relief, and improvement of quality of life (QOL) in women with new osteoporotic vertebral fractures within 1 week after onset of the fracture. Patients were randomly allocated to the teriparatide and alendronate groups. Vertebral collapse, low back pain assessed by a visual analog scale, and QOL assessed by EuroQol 5 dimension at weeks 1, 2, 4, 8, and 12 after the start of the treatment were compared between the groups. Lumbar bone mineral density (BMD) at baseline and week 12 and the rate of delayed union at week 12 were also compared. Each group consisted of 48 subjects. Vertebral collapse progressed over time in both groups, with no significant difference between the groups. Pain on rising up from lying position, turning over in bed, and resting in the lying position improved over time in both groups, with no significant difference between the groups. There were no significant differences in increase in BMD and delayed union. QOL in the teriparatide group showed significant improvement in comparison with that in the alendronate group at week 12. The weekly formulation of teriparatide showed comparable inhibition of vertebral collapse, increase in BMD, promotion of bone union, and improvement of pain and significant improvement of QOL at week 12 in comparison with alendronate in patients with a new osteoporotic vertebral fracture within 1 week after onset of the fracture. The weekly formulation of teriparatide may have improved components of QOL other than pain at week 12.


Assuntos
Alendronato/uso terapêutico , Fraturas da Coluna Vertebral/tratamento farmacológico , Teriparatida/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Alendronato/farmacologia , Densidade Óssea/efeitos dos fármacos , Conservadores da Densidade Óssea/farmacologia , Conservadores da Densidade Óssea/uso terapêutico , Esquema de Medicação , Feminino , Humanos , Qualidade de Vida , Fraturas da Coluna Vertebral/diagnóstico por imagem , Fraturas da Coluna Vertebral/fisiopatologia , Teriparatida/farmacologia , Escala Visual Analógica
3.
Bone Joint J ; 101-B(11): 1402-1407, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31674239

RESUMO

AIMS: Bone health assessment and the prescription of medication for secondary fracture prevention have become an integral part of the acute management of patients with hip fracture. However, there is little evidence regarding compliance with prescription guidelines and subsequent adherence to medication in this patient group. PATIENTS AND METHODS: The World Hip Trauma Evaluation (WHiTE) is a multicentre, prospective cohort of hip fracture patients in NHS hospitals in England and Wales. Patients aged 60 years and older who received operative treatment for a hip fracture were eligible for inclusion in WHiTE. The prescription of bone protection medications was recorded from participants' discharge summaries, and participant-reported use of bone protection medications was recorded at 120 days following surgery. RESULTS: Of 5456 recruited patients with baseline data, 2853 patients (52%) were prescribed bone protection medication at discharge, of which oral bisphosphonates were the most common, 4109 patients (75%) were prescribed vitamin D or calcium, and 606 patients (11%) were not prescribed anything. Of those prescribed a bone protection medication, only 932 patients (33%) reported still taking their medication 120 days later. CONCLUSION: These data provide a reference for current prescription and adherence rates. Adherence with oral medication remains poor in patients with hip fracture. Cite this article: Bone Joint J 2019;101-B:1402-1407.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Fraturas do Quadril/cirurgia , Idoso , Cálcio/uso terapêutico , Estudos de Coortes , Denosumab/uso terapêutico , Difosfonatos/uso terapêutico , Humanos , Hidroxicolecalciferóis/uso terapêutico , Adesão à Medicação , Pessoa de Meia-Idade , Cuidados Pós-Operatórios/métodos , Complicações Pós-Operatórias/prevenção & controle , Estudos Prospectivos , Teriparatida/uso terapêutico , Reino Unido , Vitamina D/uso terapêutico
4.
Clin Interv Aging ; 14: 1693-1703, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31631990

RESUMO

Purpose: Define the effectiveness of teriparatide (TPTD) treatment on reducing the incidence of new vertebral compression fractures (NVCFs) and back pain and improving quality of life after percutaneous kyphoplasty (PKP). Methods: Two years of clinical follow-up data from primary osteoporotic women who had experienced initial osteoporotic vertebral compression fractures (OVCFs) and received PKP plus 12-month TPTD (n=113) or basic treatment (BT) of calcium and vitamin D supplements (n=208) were retrospectively collected. The risk of NVCFs over each 6-month period in the TPTD group was evaluated and compared with the BT group using a logistic regression. Health-related quality of life (HRQoL, EQ-5D questionnaire), back pain [100 mm visual analog scale (VAS)] and bone mineral density (BMD) of the spine were analyzed using linear mixed models for repeated measures (LMMRM). Results: Logistic regression analysis adjusting for baseline characteristics showed that patients in the TPTD group had a lower risk of NVCFs compared with those receiving BT during the final three observation intervals (6-12 months, OR=0.189, 95% CI=0.030-0.681, p=0.046; 12-18 months, OR=0.009, 95% CI=0.0001-0.111, p=0.001; 18-24 months, OR=0.024, 95% CI=0.0009-0.264, p=0.009, respectively). Significant improvements in adjusted EQ-5D and back pain VAS scores were identified in the TPTD group compared with the BT group, and this improvement was sustained for at least 12 months after teriparatide treatment was discontinued (both p<0.001). The BMD of the spine also showed a higher T-value in the TPTD group compared with the BT group (p<0.001). Conclusion: In routine clinical practice, for patients with OVCFs who receive the PKP procedure, TPTD treatment may be a preferable subsequent therapy because of its ability to reduce the incidence of NVCFs and sustain a high quality of life and back pain alleviation.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Fraturas por Compressão/tratamento farmacológico , Cifoplastia/métodos , Osteoporose Pós-Menopausa/tratamento farmacológico , Fraturas por Osteoporose/dietoterapia , Qualidade de Vida , Idoso , Idoso de 80 Anos ou mais , Feminino , Fraturas por Compressão/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Osteoporose Pós-Menopausa/cirurgia , Fraturas por Osteoporose/cirurgia , Estudos Retrospectivos , Teriparatida/uso terapêutico , Resultado do Tratamento
5.
Maturitas ; 129: 12-22, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31547908

RESUMO

OBJECTIVE: To systematically evaluate the effects of bone anabolic therapies (BATs) - specifically, drug therapy with teriparatide, abaloparatide or romosozumab - on fractures, bone mineral density (BMD), and bone metabolites in postmenopausal osteoporosis. METHODS: Six computerized engines were searched through to November 2018. We selected randomized controlled trials (RCTs) evaluating the effect of BATs on postmenopausal osteoporosis and with at least 6 months of follow-up. Controls were placebo, no treatment, or bisphosphonates. Primary outcomes were vertebral and non-vertebral fractures. Secondary outcomes were: BMD determined by dual energy X-ray absorptiometry at total hip, lumbar spine, and femoral neck; N-terminal propeptide of type I procollagen (PINP); C-terminal telopeptide of type I collagen (CTX); and severe adverse events (SAE). We followed the PRISMA guidelines for reporting, and used version 2 of the Cochrane risk-of-bias tool. Frequentist network meta-analyses were performed per outcome. Effects for dichotomous and continuous outcomes were expressed as relative risks and mean differences and their 95% confidence intervals. We used p-scores to rank best treatments per outcome. RESULTS: Sixteen RCTs (n = 18,940) were evaluated. Mean ages ranged between 61 and 74 years, and follow-up times between 6 and 30 months. Four RCTs (n = 971) excluded patients with previous fractures. In contrast to placebo/no treatment, all BATs significantly reduced the risk of vertebral fractures, but no intervention significantly reduced the risk of non-vertebral fractures; abaloparatide ranked better than other interventions for both fracture types (p-scores: 0.95, and 0.89, respectively). All BATs significantly increased BMD at all locations in comparison with placebo/no treatment; romosozumab consistently ranked better than other interventions at all BMD locations (p-scores >0.86). Teriparatide ranked better than other interventions for increasing PINP. No differences in SAE were observed among treatments. CONCLUSIONS: Abaloparatide, romosozumab, and teriparatide are the best treatments, respectively, to reduce vertebral/non-vertebral fractures, increase BMD, and increase bone formation.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Conservadores da Densidade Óssea/uso terapêutico , Osteoporose Pós-Menopausa/tratamento farmacológico , Fraturas por Osteoporose/prevenção & controle , Proteína Relacionada ao Hormônio Paratireóideo/uso terapêutico , Teriparatida/uso terapêutico , Anticorpos Monoclonais/farmacologia , Densidade Óssea/efeitos dos fármacos , Conservadores da Densidade Óssea/farmacologia , Colágeno Tipo I/sangue , Feminino , Humanos , Meta-Análise em Rede , Osteoporose Pós-Menopausa/sangue , Proteína Relacionada ao Hormônio Paratireóideo/farmacologia , Fragmentos de Peptídeos/sangue , Peptídeos/sangue , Pró-Colágeno/sangue , Ensaios Clínicos Controlados Aleatórios como Assunto , Teriparatida/farmacologia
6.
G Ital Nefrol ; 36(4)2019 Jul 24.
Artigo em Italiano | MEDLINE | ID: mdl-31373465

RESUMO

Osteoporosis affects a segment of the population in which Chronic Kidney Disease is also greatly represented. Nephropathic patients may present peculiar biochemical abnormalities related to Chronic Kidney Disease, defining the Mineral and Bone Disorder. This kind of anomalies, in the worst scenarios, configure the typical histomorphology patterns of Renal Osteodystrophy. Scientific Societies of Endocrinology have established therapy guidelines for patients with osteoporosis only based on the glomerular filtration rate and recommend avoiding the use of some drugs for the more advanced classes of nephropathy. However, there is no clear therapeutic approach for patients with advanced nephropathy and bone abnormalities. In this paper we propose a systematic review of the literature and present our proposal for managing patients with advanced nephropathy, based on eGFR and on presence of Mineral and Bone Disorder.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Distúrbio Mineral e Ósseo na Doença Renal Crônica/tratamento farmacológico , Difosfonatos/uso terapêutico , Osteoporose/tratamento farmacológico , Insuficiência Renal Crônica/complicações , Anticorpos Monoclonais/uso terapêutico , Conservadores da Densidade Óssea/efeitos adversos , Conservadores da Densidade Óssea/química , Distúrbio Mineral e Ósseo na Doença Renal Crônica/etiologia , Distúrbio Mineral e Ósseo na Doença Renal Crônica/fisiopatologia , Contraindicações , Denosumab/uso terapêutico , Difosfonatos/efeitos adversos , Difosfonatos/química , Feminino , Fraturas Espontâneas/tratamento farmacológico , Fraturas Espontâneas/etiologia , Fraturas Espontâneas/prevenção & controle , Taxa de Filtração Glomerular , Humanos , Masculino , Osteoporose/complicações , Osteoporose/diagnóstico , Proteína Relacionada ao Hormônio Paratireóideo/uso terapêutico , Guias de Prática Clínica como Assunto , Insuficiência Renal Crônica/fisiopatologia , Fatores de Risco , Teriparatida/uso terapêutico
7.
Actual. osteol ; 15(2): 94-102, mayo - ago. 2019. tab.
Artigo em Espanhol | LILACS | ID: biblio-1048478

RESUMO

El propósito de la terapia en el desorden del metabolismo óseo mineral asociado a la enfermedad renal crónica (IRC) consiste en restaurar el balance mineral, y, en la osteoporosis, mantener o aumentar la masa ósea. Ambas terapias tratan de evitar la fractura ósea. La mayoría de los osteoactivos están contraindicados en la insuficiencia renal crónica avanzada (estadios 4 y 5), y las terapias son empíricas. Algunos autores opinan que sin anomalías bioquímicas del desorden del metabolismo óseo mineral asociado a la enfermedad renal crónica avanzada se podría intentar el tratamiento estándar para la osteoporosis. Antes de intentar la terapia osteoactiva se debe corregir el desorden mineral óseo que pudiera presentarse asociado a la IRC, y en la indicación del tipo de osteoactivo se sugiere seleccionar al paciente según su estado óseo. Se aconseja que la administración de los antirresortivos se realice a dosis menores con respecto a los que tienen mejor función renal junto con aportes adecuados de calcio y vitamina D, antes y durante el tratamiento para prevenir el riesgo de severas hipocalcemias y un efecto óseo excesivo. Se presenta el caso clínico de una mujer de 65 años, con diagnóstico de osteoporosis de etiología multifactorial, fractura de pelvis, múltiples fracturas vertebrales e insuficiencia renal crónica avanzada, entre otras comorbilidades, y probable enfermedad ósea adinámica. Recibió inicialmente terapia con teriparatide y luego con denosumab, complicándose con hipocalcemia asintomática. (AU)


The purpose of therapy for the bone mineral metabolism disorder associated with chronic kidney disease is to restore the mineral balance; and to maintain or increase bone mass in osteoporosis. The goal of both types of therapy is to avoid bone fractures. Most antiosteoporotic drugs are contraindicated in advanced chronic renal failure (CRF) stages 4 and 5, and the therapies are empirical. Some authors believe that without biochemical abnormalities of the mineral bone metabolism disorder associated with advanced chronic kidney disease, standard treatment for osteoporosis could be attempted. Before attempting antiosteoporotic therapy, the bone mineral disorder that may be associated with CRF must be corrected, and in the indication of the type drug it is suggested that the patient be selected according to their bone status. It is advised that the administration of anti-resorptives be performed at lower doses in individuals with poor renal function compared to those with better renal function together with adequate calcium and vitamin D, before and during treatment to prevent the risk of severe hypocalcemia, and an excessive bone effect. We present the clinical case of a 65-year-old woman with a diagnosis of osteoporosis of multifactorial etiology, pelvic fracture, multiple vertebral fractures and advanced chronic renal failure, among other comorbidities and probable adynamic bone disease. The patient received initial therapy with teriparatide and followed by denosumab administration and exhibited asymptomatic hypocalcemia. (AU)


Assuntos
Humanos , Feminino , Idoso , Distúrbio Mineral e Ósseo na Doença Renal Crônica/tratamento farmacológico , Fraturas Ósseas/prevenção & controle , Osteoporose/terapia , Distúrbio Mineral e Ósseo na Doença Renal Crônica/complicações , Distúrbio Mineral e Ósseo na Doença Renal Crônica/metabolismo , Distúrbio Mineral e Ósseo na Doença Renal Crônica/terapia , Vitamina D/administração & dosagem , Vitamina D/uso terapêutico , Cálcio/administração & dosagem , Cálcio/uso terapêutico , Alendronato/uso terapêutico , Teriparatida/administração & dosagem , Teriparatida/efeitos adversos , Teriparatida/uso terapêutico , Difosfonatos/administração & dosagem , Difosfonatos/efeitos adversos , Difosfonatos/uso terapêutico , Cinacalcete/uso terapêutico , Ácido Risedrônico/uso terapêutico , Denosumab/administração & dosagem , Denosumab/efeitos adversos , Denosumab/uso terapêutico , Hipocalcemia/prevenção & controle
8.
BMJ Case Rep ; 12(7)2019 Jul 23.
Artigo em Inglês | MEDLINE | ID: mdl-31340943

RESUMO

A 35-year-old man with juvenile idiopathic arthritis since childhood presented with bilateral atypical tibial fractures, followed by a later, single atypical fracture of the femur. The fractures were associated with 6 years of oral alendronate treatment immediately followed by subcutaneous denosumab therapy and later teriparatide therapy for osteoporosis. Atypical fractures are known to occur in the femur following bisphosphonate therapy; however, there are only a few documented cases of atypical fractures in the tibia. Our case highlights a rare but serious complication of a commonly prescribed antiresorptive agent. It also shows that teriparatide, while helpful in increasing bone mass, does not fully prevent the development of atypical fractures. Careful investigation should be considered in patients on long-term antiresorptive therapy presenting with bony tenderness to exclude an atypical fracture.


Assuntos
Alendronato/efeitos adversos , Denosumab/efeitos adversos , Fraturas Espontâneas/induzido quimicamente , Osteoporose/tratamento farmacológico , Teriparatida/efeitos adversos , Absorciometria de Fóton/métodos , Adulto , Alendronato/uso terapêutico , Densidade Óssea/fisiologia , Denosumab/uso terapêutico , Relação Dose-Resposta a Droga , Esquema de Medicação , Fraturas do Fêmur/induzido quimicamente , Fraturas do Fêmur/diagnóstico por imagem , Seguimentos , Fraturas Espontâneas/diagnóstico por imagem , Humanos , Masculino , Osteoporose/diagnóstico por imagem , Medição de Risco , Teriparatida/uso terapêutico , Fraturas da Tíbia/induzido quimicamente , Fraturas da Tíbia/diagnóstico por imagem
9.
J Biol Regul Homeost Agents ; 33(2 Suppl. 1): 57-62, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31169004

RESUMO

A case of shoulder periprosthetic fracture in elderly patient. The patient underwent a minimally invasive osteosynthesis and "off-label" treatment with teriparatide. An 80-year-old woman patient following an accidental fall reported a transverse displaced diaphyseal fracture of the right humerus, distal to the stem of the inverse prosthesis. The patient suffering from severe osteoporosis and chronic ischaemic heart disease. The patient underwent fracture osteosynthesis surgery using a Hoffmann III mono-axial external fixator. Teriparatide administered at a dosage of 20 micrograms/day, for four months. At six months from the beginning of th e hybrid treatment, a complete healing of the fracture was observed radiologically and clinically. It is possible to affirm that the use of teriparatide off-label has a positive and additive effect in promoting the healing of fractures.


Assuntos
Fixação Interna de Fraturas , Fraturas Periprotéticas/cirurgia , Fraturas Periprotéticas/terapia , Teriparatida/uso terapêutico , Idoso de 80 Anos ou mais , Feminino , Consolidação da Fratura , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos , Uso Off-Label , Ombro/cirurgia , Lesões do Ombro/cirurgia , Lesões do Ombro/terapia
10.
Drugs Aging ; 36(7): 625-638, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31066015

RESUMO

In patients with osteoporosis and severely reduced bone mass and/or recurring fractures, antiresorptive therapy may not be the optimal first-line treatment. Two recent clinical trials comparing bone-forming treatment with antiresorptive therapy have demonstrated that bone-forming treatment is superior in reducing the fracture risk in patients with severe osteoporosis. All of the currently available bone-forming agents-teriparatide, abaloparatide, and romosozumab-increase bone mineral density (BMD) and reduce the fracture risk; however, the effect wears off with time and treatment is therefore only transient. Thus, a bone-forming therapy should be followed by antiresorptive treatment with a bisphosphonate or denosumab. The BMD response to bone-forming treatment is reduced in patients previously treated with antiresorptive drugs; however, based on the findings of the VERO trial, the anti-fracture efficacy of bone-forming treatment in comparison with antiresorptives seems to be preserved. This review provides an overview of the existing bone-forming therapies for osteoporosis including considerations of sequential and combination therapy.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Osteoporose/tratamento farmacológico , Anticorpos Monoclonais/uso terapêutico , Densidade Óssea/efeitos dos fármacos , Reabsorção Óssea/tratamento farmacológico , Ensaios Clínicos Fase III como Assunto , Denosumab/uso terapêutico , Difosfonatos/uso terapêutico , Quimioterapia Combinada , Humanos , Osteogênese/efeitos dos fármacos , Proteína Relacionada ao Hormônio Paratireóideo/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Teriparatida/uso terapêutico
11.
BMC Surg ; 19(1): 35, 2019 Apr 05.
Artigo em Inglês | MEDLINE | ID: mdl-30953554

RESUMO

BACKGROUND: Arteriovenous malformations (AVMs) are rare congenital vascular lesions associated with early quiescence, late expansion, and, ultimately, infiltration and destruction of local soft tissue and bone. The extremities are a common location. Incidence of bony involvement by AVM has been reported as high as 31%. However, there are few reports on management of pathologic fracture associated with AVM. Teriparatide is a recombinant parathyroid hormone (PTH) analogue consisting of the 1-34 fragment of PTH. Recently, some reports have shown the ability of teriparatide to improve fracture healing. Here, we present a case of pathologic femoral shaft fracture associated with large AVMs that was treated successfully by external fixation and teriparatide. CASE PRESENTATION: A 68-year-old Japanese woman, previously diagnosed as having large AVMs, sustained a right femoral shaft fracture due to a fall. At the time of admission, she presented with massive swelling and venous varicosities of the right thigh. Plain radiography of the right thigh revealed femoral shaft fracture with bony erosion and calcification of soft tissue. We planned closed reduction and intramedullary nailing with a unilateral external fixator following embolization of the feeding artery. However, closed reduction using the fracture table was difficult. When we attempted open reduction, massive bleeding (1000 mL) after incision of subcutaneous tissue occurred. Finally, we carefully applied a Taylor Spatial Frame. Fracture displacement was corrected successfully and bony union was obtained with administration of teriparatide 15 months after the initial surgery. The patient is able to walk using 1 cane. CONCLUSION: We present the first report of pathologic fracture associated with large AVMs that achieved bony union using a 3-dimensional external fixator and teriparatide.


Assuntos
Malformações Arteriovenosas/cirurgia , Conservadores da Densidade Óssea/uso terapêutico , Fraturas do Fêmur/terapia , Fixação de Fratura/métodos , Fraturas Espontâneas/terapia , Teriparatida/uso terapêutico , Idoso , Malformações Arteriovenosas/complicações , Malformações Arteriovenosas/diagnóstico por imagem , Diáfises/irrigação sanguínea , Diáfises/diagnóstico por imagem , Diáfises/efeitos dos fármacos , Diáfises/cirurgia , Fixadores Externos , Feminino , Artéria Femoral , Fraturas do Fêmur/complicações , Fraturas do Fêmur/diagnóstico por imagem , Fêmur/irrigação sanguínea , Fêmur/diagnóstico por imagem , Fêmur/efeitos dos fármacos , Fêmur/cirurgia , Fixação de Fratura/instrumentação , Fraturas Espontâneas/complicações , Fraturas Espontâneas/diagnóstico por imagem , Humanos
12.
Int J Surg ; 66: 1-11, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30890377

RESUMO

OBJECTIVE: This meta-analysis aims to compare the efficacy of teriparatide and bisphosphonates for reducing vertebral fracture risk and bone mineral density (BMD) in lumbar spine and femoral neck in postmenopausal women with osteoporosis. METHODS: We searched the literature, via PubMed, Embase, Cochrane Library, Web of Science and Google database to screen citations from inception to April 2018 for inclusion in this study. Only randomized controlled trials that compared teriparatide and bisphosphonates for reducing vertebral fracture risk in postmenopausal women with osteoporosis were included. Stata 12.0 was used for meta-analysis. RESULTS: Our meta-analysis results indicated that, compared with bisphosphonates, teriparatide was associated with a reduction of the vertebral fracture risk (risk ratio (RR) = 0.57, 95% confidence interval (CI): 0.35, 0.93, P = 0.024). Furthermore, teriparatide therapy increased the mean percent change in BMD in lumbar spine of 6 months, 12 months and 18 months than bisphosphonates with statistically significant (P < 0.05). And, teriparatide has only beneficial in increasing the mean percent change in BMD in femoral neck of 18 months (P < 0.05). There was no significant difference between teriparatide and bisphosphonates in terms of the adverse events (AEs, RR = 1.09, 95% CI 0.89, 1.33, P = 0.424). CONCLUSIONS: Teriparatide is an effective agent in reducing the risk of vertebral fracture in postmenopausal women with osteoporosis. Furthermore, teriparatide can increase the BMD in lumbar spine and femoral neck in long-terms duration.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Difosfonatos/uso terapêutico , Osteoporose Pós-Menopausa/tratamento farmacológico , Teriparatida/uso terapêutico , Densidade Óssea/efeitos dos fármacos , Feminino , Humanos , Vértebras Lombares/fisiopatologia , Osteoporose Pós-Menopausa/complicações , Osteoporose Pós-Menopausa/fisiopatologia , Viés de Publicação , Comportamento de Redução do Risco , Fraturas da Coluna Vertebral/etiologia , Fraturas da Coluna Vertebral/fisiopatologia , Fraturas da Coluna Vertebral/prevenção & controle
13.
Clin Oral Investig ; 23(11): 3987-3993, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30715621

RESUMO

OBJECTIVE: The aim of this study was to evaluate the effect of teriparatide therapy on mandibular fracture healing in rats with medication-related osteonecrosis of the jaw (MRONJ). MATERIALS AND METHODS: To induce MRONJ, a total of 120 rats received intravenous zoledronate 0.06 mg/kg once a week for 6 weeks and their right mandibular first molar was extracted. Eighty of 94 rats with MRONJ were randomly selected and underwent unilateral mandibular osteotomy to replicate a fracture. After surgery, the rats were randomly assigned to T (teriparatide-treated) and C (control) groups. Group T (n = 40) received subcutaneous injection of 2 µg/kg/day teriparatide and group C (n = 40) received the same volume of normal saline until sacrifice. Four and 8 weeks after surgery, 20 rats in each group were sacrificed. Fracture healing was scored using a histological grading system (1 to 10). RESULTS: In group C, at 4 weeks and 8 weeks post-fracture, fibrous and cartilaginous tissues and scant bone formation at the fracture site and lacunae without osteocyte in adjacent mandibular bone were seen. In group T, substantial amounts of new trabecular bone rimmed by osteoblasts and some areas of remodeled mature bone were seen. After 8 weeks, extensive replacement of trabecular bone with mature bone occurred. Except between C4 and C8 groups, the healing score was significantly different between all subgroups. CONCLUSION: Teriparatide therapy successfully improved mandibular fracture healing in rats with MRONJ. However, this study was limited by the use of an animal model whose anatomy, physiology, and drug metabolism might be different from humans. CLINICAL RELEVANCE: The present study showed that teriparatide therapy may be used adjunctive to surgery in the treatment of mandibular fractures in MRONJ patients.


Assuntos
Osteonecrose da Arcada Osseodentária Associada a Difosfonatos , Conservadores da Densidade Óssea , Fraturas Mandibulares , Teriparatida , Animais , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/complicações , Conservadores da Densidade Óssea/uso terapêutico , Consolidação da Fratura/efeitos dos fármacos , Fraturas Mandibulares/tratamento farmacológico , Ratos , Teriparatida/uso terapêutico
14.
Lancet ; 393(10169): 364-376, 2019 01 26.
Artigo em Inglês | MEDLINE | ID: mdl-30696576

RESUMO

Fractures resulting from osteoporosis become increasingly common in women after age 55 years and men after age 65 years, resulting in substantial bone-associated morbidities, and increased mortality and health-care costs. Research advances have led to a more accurate assessment of fracture risk and have increased the range of therapeutic options available to prevent fractures. Fracture risk algorithms that combine clinical risk factors and bone mineral density are now widely used in clinical practice to target high-risk individuals for treatment. The discovery of key pathways regulating bone resorption and formation has identified new approaches to treatment with distinctive mechanisms of action. Osteoporosis is a chronic condition and long-term, sometimes lifelong, management is required. In individuals at high risk of fracture, the benefit versus risk profile is likely to be favourable for up to 10 years of treatment with bisphosphonates or denosumab. In people at a very high or imminent risk of fracture, therapy with teriparatide or abaloparatide should be considered; however, since treatment duration with these drugs is restricted to 18-24 months, treatment should be continued with an antiresorptive drug. Individuals at high risk of fractures do not receive adequate treatment and strategies to address this treatment gap-eg, widespread implementation of Fracture Liaison Services and improvement of adherence to therapy-are important challenges for the future.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Denosumab/uso terapêutico , Difosfonatos/uso terapêutico , Osteoporose/tratamento farmacológico , Osteoporose/epidemiologia , Fraturas por Osteoporose/prevenção & controle , Teriparatida/uso terapêutico , Idoso , Densidade Óssea , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Osteoporose/fisiopatologia , Proteína Relacionada ao Hormônio Paratireóideo/uso terapêutico , Fatores de Risco
15.
Osteoporos Int ; 30(3): 667-673, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30635696

RESUMO

Early PINP changes correlate with 18-month lumbar spine BMD changes and the correlation was greater with abaloparatide versus teriparatide. The uncoupling index was similar between the two agents. INTRODUCTION: We evaluated the relationship between early PINP changes and subsequent changes in spine BMD following abaloparatide and teriparatide treatments. We also explored the use of an "uncoupling index" (UI), the balance between bone formation and bone resorption, which we hypothesised would be similar in response to these treatment groups. METHODS: Blood samples were taken for measurement of bone turnover markers (BTMs) s-PINP and s-CTX at baseline, 1, 3, 6, 12, and 18 months from 189 abaloparatide patients and 227 teriparatide patients randomly selected from all participants who completed the study. BMD was measured by DXA at baseline, 6, 12, and 18 months. Correlations were calculated between log ratio of BTMs from baseline to 3 months and percent change from baseline in BMD at 18 months. A UI was calculated using log transformation and subtraction of the standard deviate for s-CTX from the standard deviate for s-PINP for each patient. RESULTS: Early BTM changes were associated with subsequent BMD changes for both treatments. Pearson correlations for the log ratio of PINP over baseline at 3 months and BMD percent change from baseline at 18 months were larger (P < 0.0001) with abaloparatide (r = 0.561) than teriparatide (r = 0.198). The mean UI at 1 month was greater for abaloparatide versus teriparatide (1.743 and 1.493, respectively; P = 0.03) but was similar at 3 months or later time points. CONCLUSIONS: Early s-PINP changes correlate with percentage change in lumbar spine BMD 18 months after treatment with both abaloparatide and teriparatide, though the correlation with abaloparatide was greater. The UI was similar between abaloparatide and teriparatide suggesting that the balance between formation and resorption markers was similar.


Assuntos
Conservadores da Densidade Óssea/farmacologia , Remodelação Óssea/efeitos dos fármacos , Osteoporose Pós-Menopausa/fisiopatologia , Proteína Relacionada ao Hormônio Paratireóideo/farmacologia , Teriparatida/farmacologia , Idoso , Biomarcadores/sangue , Densidade Óssea/efeitos dos fármacos , Densidade Óssea/fisiologia , Conservadores da Densidade Óssea/uso terapêutico , Remodelação Óssea/fisiologia , Colágeno Tipo I/sangue , Método Duplo-Cego , Feminino , Humanos , Vértebras Lombares/fisiopatologia , Pessoa de Meia-Idade , Osteoporose Pós-Menopausa/sangue , Osteoporose Pós-Menopausa/tratamento farmacológico , Proteína Relacionada ao Hormônio Paratireóideo/uso terapêutico , Fragmentos de Peptídeos/sangue , Peptídeos/sangue , Pró-Colágeno/sangue , Teriparatida/uso terapêutico
16.
Oral Dis ; 25(3): 822-830, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30633848

RESUMO

OBJECTIVE: To determine the synergistic effect of parathyroid hormone (PTH) [1-34] in combination with hyperbaric oxygen (HBO) on bone graft in a rat calvarial bone defect model under impaired osteogenic conditions. MATERIALS AND METHODS: Twenty-four rats were divided into three groups. Localized radiation with a single 12 Gy dose was administered to the calvaria. Four weeks after radiation, calvarial circular defects were created in the parietal bones. All defects were filled with biphasic calcium phosphate. After the bone graft, PTH [1-34] was injected subcutaneously, and HBO was administered. At 6 weeks after the bone graft, the rats were sacrificed, and specimens were harvested. RESULTS: Histomorphometric evaluation showed that the percentage of new bone area was higher in the PTH and PTH/HBO groups than in the control group. The percent residual material area was decreased in the PTH/HBO group compared with the control group. The percentage blood vessel number was highest in the PTH group. Micro-CT evaluation showed that the new bone volume was highest in the PTH/HBO group. The residual material volume was lowest in the PTH/HBO group. CONCLUSION: Within the limitations of this study, our data indicate that PTH combined with HBO may reverse radiation-induced impairment of bone healing.


Assuntos
Oxigenação Hiperbárica , Osteogênese/efeitos dos fármacos , Fragmentos de Peptídeos/uso terapêutico , Crânio/fisiologia , Crânio/cirurgia , Teriparatida/análogos & derivados , Animais , Substitutos Ósseos , Terapia Combinada , Hidroxiapatitas , Masculino , Osteogênese/efeitos da radiação , Ratos , Ratos Sprague-Dawley , Crânio/diagnóstico por imagem , Crânio/patologia , Teriparatida/uso terapêutico , Microtomografia por Raio-X
17.
J Bone Miner Metab ; 37(2): 256-263, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29721806

RESUMO

Despite preclinical studies demonstrating the effectiveness of teriparatide for skeletal repair in small animals, inconclusive data from clinical trials have raised questions regarding the optimal teriparatide dosing regimen for bone repair. To address this, we assessed the effect of teriparatide frequency and dose on long-bone healing using a mouse femur osteotomy/fracture model. Eight-week-old male ICR mice were subjected to open femur osteotomies, then randomized into following five groups (n = 8 per group): vehicle; low dose/high frequency: 3 µg/kg/dose, 3 times/day; low dose/low frequency: 9 µg/kg/dose, 1 time/day; high dose/high frequency: 9 µg/kg/dose, 3 times/day; high dose/low frequency: 27 µg/kg/dose, 1 time/day. Skeletal repair was assessed by microcomputed tomography, mechanical testing, and histology 4 weeks after surgery. High-dose and/or high-frequency teriparatide treatment increased callus bone volume but failed to have a significant impact on the biomechanical recovery of fractured femurs, possibly because of impaired cortical shell formation in fracture calluses. Meanwhile, low-dose/low-frequency teriparatide therapy enhanced callus bone formation without interfering with cortical shell formation despite a lesser increase in callus bone volume, leading to significant two and fourfold increases in ultimate load and stiffness, respectively. Our findings demonstrate that administering teriparatide at higher doses and/or higher frequencies raises fracture callus volume but does not always accelerate the biomechanical recovery of fractured bone, which points to the importance of finding the optimal teriparatide dosing regimen for accelerating skeletal repair.


Assuntos
Fraturas do Fêmur/tratamento farmacológico , Consolidação da Fratura/efeitos dos fármacos , Teriparatida/administração & dosagem , Teriparatida/uso terapêutico , Animais , Fenômenos Biomecânicos , Calo Ósseo , Modelos Animais de Doenças , Relação Dose-Resposta a Droga , Esquema de Medicação , Fraturas do Fêmur/diagnóstico por imagem , Fraturas do Fêmur/patologia , Fraturas do Fêmur/fisiopatologia , Fêmur/diagnóstico por imagem , Fêmur/efeitos dos fármacos , Fêmur/patologia , Fêmur/cirurgia , Humanos , Masculino , Camundongos Endogâmicos ICR , Osteotomia , Teriparatida/farmacologia , Microtomografia por Raio-X
18.
J Craniomaxillofac Surg ; 47(1): 120-126, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30528562

RESUMO

OBJECTIVE: To evaluate the effects of short-term teriparatide administration on healing of autologous bone graft in mandibular critical-size defects. SUBJECTS AND METHODS: A 5-mm mandibular bone defect was created and iliac bone graft was harvested in 135 rats. Rats were randomly divided into 3 groups of negative control (NC), control (C), and study (S). In groups S and C, iliac graft was placed in defect and 2 µg/kg/day teriparatide or saline, respectively, was administered for 20 days. In group NC, iliac graft was not transferred to the defect and saline was injected for 20 days. Twenty, 40, and 60 days after surgery, 15 rats in each group were euthanized and the healing process was histologically evaluated and scored using a grading system (1-6). RESULTS: In group NC, defects did not heal or were predominantly filled with fibrous tissue. At day 20, bone defects in both C and S groups contained a large area of graft particles, numerous collagen fibers and some areas of new trabeculae. At the day 40, defects in group S showed a larger bone graft area, more new bone formation, smaller connective tissue area, and a higher healing score compared to group C (P < 0.05). At day 60, most of the defect in group S was filled with graft particles and mature bone while in group C, new trabecular bone formation was still underway (P < 0.05). CONCLUSION: Teriparatide therapy improves healing of bone defects reconstructed with autograft by reducing bone graft resorption and enhancing new bone formation and maturation.


Assuntos
Transplante Ósseo , Mandíbula/cirurgia , Teriparatida/uso terapêutico , Transplante Autólogo , Cicatrização/efeitos dos fármacos , Análise de Variância , Animais , Doenças Ósseas/diagnóstico por imagem , Doenças Ósseas/patologia , Doenças Ósseas/cirurgia , Regeneração Óssea/efeitos dos fármacos , Remodelação Óssea , Tecido Conjuntivo/patologia , Modelos Animais de Doenças , Consolidação da Fratura/efeitos dos fármacos , Masculino , Mandíbula/diagnóstico por imagem , Mandíbula/patologia , Osteogênese/efeitos dos fármacos , Ratos , Ratos Wistar , Solução Salina/uso terapêutico , Teriparatida/administração & dosagem
19.
Osteoporos Int ; 30(3): 675-683, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30357438

RESUMO

To demonstrate the clinical comparability between RGB-10 (a biosimilar teriparatide) and the originator, a comparative pharmacokinetic trial was conducted. The study was successful in establishing bioequivalence. Marketing authorisation for RGB-10 (Terrosa®) was granted by the European Medicines Agency in 2017. INTRODUCTION: Teriparatide, the first bone anabolic agent, is the biologically active fragment of human parathyroid hormone. The imminent patent expiry of the originator will open the door for biosimilars to enter the osteology market, thereby improving access to a highly effective, yet prohibitively expensive therapy. METHODS: Subsequent to establishing comparability on the quality and non-clinical levels between RGB-10, a biosimilar teriparatide, and its reference product (Forsteo®), a randomised, double-blind, 2-way cross-over comparative study (duration: four days) was conducted in 54 healthy women (ages: 18 to 55 years) to demonstrate the pharmacokinetic/pharmacodynamic (PK/PD) equivalence and comparable safety of these products. Extents of exposure (AUC0-tlast) and peak exposure (Cmax), as measured by means of ELISA, were evaluated as co-primary PK endpoints, and serum calcium levels, as measured using standard automated techniques, were assessed for PD effects. Safety was monitored throughout the study. RESULTS: The 94.12% CIs for the ratio of the test to the reference treatments, used due to the two-stage design (85.20-98.60% and 85.51-99.52% for AUC0-tlast and Cmax, respectively), fell within the 80.00-125.00% acceptance range. The calcium PD parameters were essentially identical with geometric mean ratios (GMRs) of 99.93% and 99.87% for AUC and Cmax, respectively. Analysis of the safety data did not reveal any differences between RGB-10 and its reference. CONCLUSION: Based on the high level of similarity in the preclinical data and the results of this clinical study, marketing authorisation for RGB-10 (Terrosa®) was granted by the European Medicines Agency (EMA) in 2017.


Assuntos
Medicamentos Biossimilares/farmacologia , Medicamentos Biossimilares/farmacocinética , Conservadores da Densidade Óssea/farmacologia , Conservadores da Densidade Óssea/farmacocinética , Osteoporose/tratamento farmacológico , Teriparatida/farmacologia , Teriparatida/farmacocinética , Adolescente , Adulto , Medicamentos Biossimilares/efeitos adversos , Medicamentos Biossimilares/uso terapêutico , Conservadores da Densidade Óssea/efeitos adversos , Conservadores da Densidade Óssea/uso terapêutico , Cálcio/sangue , Estudos Cross-Over , Método Duplo-Cego , Feminino , Meia-Vida , Humanos , Injeções Subcutâneas , Pessoa de Meia-Idade , Teriparatida/efeitos adversos , Teriparatida/uso terapêutico , Equivalência Terapêutica , Adulto Jovem
20.
Eur J Orthop Surg Traumatol ; 29(1): 169-173, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29931529

RESUMO

The absence of osseous consolidation of a fracture for 9 or more months with no potential to heal is defined as nonunion. Both for the patient and from a socioeconomic point of view, nonunions represent a major problem. Hypertrophic, vital nonunions are distinguished from atrophic avital ones. Risk factors for a delayed fracture healing are insufficient immobilisation, poor adaptation of the fracture surfaces or residual instability, interposition of soft tissue within the fracture gap, as well as circulation disturbances and infections. The incidence of nonunions after fractures of the long bones lies between 2.6 and 16% depending on the surgical technique used. In human and animal studies, a positive effect of parathyroid hormone (PTH) on fracture healing has been shown. PTH has a direct stimulatory effect on osteoblasts and osteoclasts. In addition, it appears to influence the effect of osseous growth factors. In this prospective study, 32 patients with nonunions were treated with teriparatide to investigate the effects of PTH on fracture healing. Definitive healing of the nonunions following PTH treatment could be observed in 95% of the cases.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Consolidação da Fratura/efeitos dos fármacos , Fraturas não Consolidadas/tratamento farmacológico , Teriparatida/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Uso Off-Label , Estudos Prospectivos , Adulto Jovem
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