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4.
J Bone Miner Metab ; 38(6): 894-902, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32656645

RESUMO

INTRODUCTION: Rapid descent in bone mineral density (BMD) and ascent in bone turnover marker (BTM) occur within the short period following denosumab (Dmab) discontinuation. In addition, the incidence of vertebral fracture also rises within the short period. The purpose of this study is to investigate the effects of sequential therapy using zoledronic acid (ZOL) on any adverse events after Dmab discontinuation. MATERIALS AND METHODS: This study was a multicenter retrospective observational study, and the subjects were osteoporosis patients who visited our institutions between 2013 and 2018. We performed sequential therapy using ZOL for 30 patients who had difficulty continuing Dmab, due to physical or social reasons, and investigated the fracture incidence and BMD/BTM changes at 4 time points (at the start of Dmab, the start of ZOL, 6 months after ZOL and 12 months after ZOL). RESULTS: No new vertebral/nonvertebral fractures were observed at each time point after switching from Dmab to ZOL in any of the 30 patients. The BMD/BTM changes were evaluated in 18 of the 30 cases, since all data of lumbar/femoral neck BMDs and TRACP-5b at 4 time points was only available in 18 cases. BMDs significantly increased at each time point compared with that at the start of Dmab. Serum TRACP-5b significantly decreased at each time point compared with that at the start of Dmab. CONCLUSION: It was suggested that sequential therapy using ZOL could suppress the decrease of BMD, and increase of BTM, if the period of Dmab administration was less than 3 years.


Assuntos
Denosumab/uso terapêutico , Suspensão de Tratamento , Ácido Zoledrônico/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Densidade Óssea/efeitos dos fármacos , Conservadores da Densidade Óssea/efeitos adversos , Conservadores da Densidade Óssea/uso terapêutico , Remodelação Óssea/efeitos dos fármacos , Denosumab/efeitos adversos , Feminino , Fraturas Ósseas/sangue , Fraturas Ósseas/epidemiologia , Fraturas Ósseas/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Osteoporose/sangue , Estudos Retrospectivos , Fosfatase Ácida Resistente a Tartarato/sangue , Ácido Zoledrônico/efeitos adversos
5.
Gan To Kagaku Ryoho ; 47(7): 1059-1062, 2020 Jul.
Artigo em Japonês | MEDLINE | ID: mdl-32668852

RESUMO

Denosumab is widely used for treating bone metastases in patients with advanced cancer. However, hypocalcemia has been reported as a serious adverse effect during this treatment. Therefore, monitoring serum calcium concentration is essential. During long-term continuous administration ofdenosumab, the burden ofeach blood sampling occasion and medical economics should be clarified; however, the appropriate blood sampling frequency has not yet been confirmed. In the present study, we performed a retrospective investigation of serum calcium concentration after denosumab administration. The results indicated that serum calcium concentration tended to increase with repeated administration. A significant increase was observed at the time ofthe third and sixth administration. This suggested that it was possible to reduce the frequency ofblood sampling during long-term administration ofdenosumab with appropriate calcium supplementation.


Assuntos
Denosumab/efeitos adversos , Hipocalcemia , Conservadores da Densidade Óssea , Cálcio , Humanos , Hipocalcemia/induzido quimicamente , Estudos Retrospectivos
6.
Artigo em Inglês | MEDLINE | ID: mdl-32536575

RESUMO

OBJECTIVE: The aim of this study was to prospectively determine the incidence of medication-related osteonecrosis of the jaw (MRONJ) and define risk factors in patients with metastatic breast cancer treated with zoledronic acid and/or denosumab. STUDY DESIGN: In a prospective cohort study performed in Region Skåne, Sweden, from January 1, 2012, until December 31, 2015, all patients with breast cancer who had radiographic evidence of bone metastases and were treated with zoledronic acid or denosumab were included and followed up until May 31, 2018. RESULTS: Of the 242 patients, MRONJ developed in 16 (6.6%) during the 77 months of study. The incidence of MRONJ in patients treated with zoledronic acid was 4.1%, and in patients treated with denosumab, it was 13.6%. The risk of MRONJ was higher in patients on denosumab than in those treated with zoledronic acid (P = .011). Corticosteroid use was associated with a decreased risk of MRONJ (P = .008), and diabetes was associated with an increased risk of MRONJ (P = .02). CONCLUSIONS: The incidence of MRONJ is 13.6% (>3 times higher) in denosumab-treated patients with breast cancer compared with that in patients treated with zoledronic acid (4.1%). Corticosteroid use decreased the risk of MRONJ.


Assuntos
Osteonecrose da Arcada Osseodentária Associada a Difosfonatos , Conservadores da Densidade Óssea , Neoplasias da Mama , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/epidemiologia , Conservadores da Densidade Óssea/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/epidemiologia , Denosumab/efeitos adversos , Difosfonatos/efeitos adversos , Feminino , Humanos , Incidência , Estudos Prospectivos , Fatores de Risco , Suécia/epidemiologia
8.
J Bone Miner Res ; 35(6): 1009-1013, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32406536

RESUMO

Osteoporosis is a chronic condition that reflects reduced bone strength and an associated increased risk for fracture. As a chronic condition, osteoporosis generally requires sustained medical intervention(s) to limit the risks for additional bone loss, compromise of skeletal integrity, and fracture occurrence. Further complicating this issue is the fact that the abrupt cessation of some therapies can be associated with an increased risk for harm. It is in this context that the COVID-19 pandemic has brought unprecedented disruption to the provision of health care globally, including near universal requirements for social distancing. In this Perspective, we provide evidence, where available, regarding the general care of patients with osteoporosis in the COVID-19 era and provide clinical recommendations based primarily on expert opinion when data are absent. Particular emphasis is placed on the transition from parenteral osteoporosis therapies. It is hoped that these recommendations can be used to safely guide care for patients with osteoporosis until a return to routine clinical care standards is available. © 2020 American Society for Bone and Mineral Research.


Assuntos
Infecções por Coronavirus , Osteoporose/terapia , Pandemias , Pneumonia Viral , Absorciometria de Fóton , Biomarcadores/sangue , Densidade Óssea , Conservadores da Densidade Óssea/administração & dosagem , Conservadores da Densidade Óssea/efeitos adversos , Conservadores da Densidade Óssea/uso terapêutico , Continuidade da Assistência ao Paciente , Infecções por Coronavirus/sangue , Infecções por Coronavirus/complicações , Denosumab/efeitos adversos , Denosumab/uso terapêutico , Gerenciamento Clínico , Esquema de Medicação , Terapia de Reposição de Estrogênios/efeitos adversos , Fraturas Espontâneas/prevenção & controle , Fraturas Espontâneas/terapia , Serviços de Assistência Domiciliar , Humanos , Imunossupressão/efeitos adversos , Osteoporose/sangue , Osteoporose/diagnóstico por imagem , Osteoporose/tratamento farmacológico , Pneumonia Viral/sangue , Pneumonia Viral/complicações , Cloridrato de Raloxifeno/efeitos adversos , Cloridrato de Raloxifeno/uso terapêutico , Recidiva , Telemedicina , Trombofilia/induzido quimicamente , Trombofilia/etiologia , Procedimentos Desnecessários
9.
Med. oral patol. oral cir. bucal (Internet) ; 25(3): e326-e336, mayo 2020. tab, graf
Artigo em Inglês | IBECS | ID: ibc-196318

RESUMO

BACKGROUND: The aim of the present study was to analyse the incidence, risk ratio (RR) and prognoses of two types of medication-related osteonecrosis of the jaws (MRONJ): denosumab-related osteonecrosis of the jaws (DRONJ) and Bisphosphonate-Related Osteonecrosis of the Jaws (BRONJ) in cancer patients under treatment with deno-sumab or zoledronic acid (ZA). MATERIAL AND METHODS: An electronic and manual search was conducted for randomized controlled trials (RCTs) until May 2019. Assessment of the identified studies, risk of bias and data extraction were performed independently by two reviewers. The incidence of DRONJ and BRONJ and the RR to develop MRONJ were calculated at 1 year, 2 years and 3 years of exposure. It was also calculated the odds ratio (OR) of their respective prognoses. They were calculated normalizing the values of the individual studies to 1 year, 2 years or 3 years when necessary through robust regression models using a statistical program. RESULTS: From 1.277 references identified, 8 RCTs were included, which comprised a total of 13.857 patients with a variety of neoplasms. The incidence of DRONJ in cancer patients under treatment with denosumab ranged from 0.5 to 2.1% after 1 year, 1.1 to 3.0% after 2 years, and 1.3 to 3.2% after 3 years of exposure. The incidence of BRONJ in cancer patients under treatment with ZA ranged from 0.4 to 1.6% after 1 year of exposure, 0.8 to 2.1% after 2 years, and 1.0 to 2.3% after 3 years of exposure. Statistically significant differences were found between de-nosumab and ZA in the risk of developing MRONJ after 1, 2 and 3 years of exposure. Nevertheless, there were no significant differences in terms of patient prognosis. CONCLUSIONS: Denosumab is associated with a significantly higher risk of developing MRONJ compared to ZA. Nevertheless, no differences were found in its prognoses


No disponible


Assuntos
Humanos , Masculino , Feminino , Osteonecrose/induzido quimicamente , Denosumab/efeitos adversos , Ácido Zoledrônico/efeitos adversos , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/etiologia , Doenças Maxilomandibulares/induzido quimicamente , Medição de Risco , Fatores de Risco , Ensaios Clínicos Controlados Aleatórios como Assunto , Neoplasias/tratamento farmacológico , Fatores de Tempo
10.
Lancet Diabetes Endocrinol ; 8(5): 407-417, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32333877

RESUMO

BACKGROUND: Medical treatment options for primary hyperparathyroidism are scarce. We aimed to assess the efficacy of denosumab and combined with cinacalcet in patients with primary hyperparathyroidism. METHODS: In this randomised, single-centre, proof-of-concept, double-blind trial, patients aged at least 18 years with primary hyperparathyroidism were recruited from the Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark. Key eligibility criteria were a T-score between -1·0 and -3·5 at the lumbar spine, femoral neck, or total hip. Patients were assigned (1:1:1) via permuted block randomisation to receive 30 mg cinacalcet per day plus 60 mg denosumab subcutaneously every 6 months (n=14; combination group) for 1 year, denosumab plus placebo (n=16; denosumab group) for 1 year, or placebo plus placebo injection (n=15; placebo group) for 1 year. Primary outcomes were changes in bone mineral density (BMD) measured by dual x-ray absorptiometry at the lumbar spine, total hip, femoral neck, and distal forearm after 1 year. Additionally, effects on bone-metabolic biochemistry were explored. Patients and investigators were masked. All enrolled patients were included in efficacy analyses. The trial was done in an outpatient setting and is registered at ClinicalTrials.gov, NCT03027557, and has been completed. FINDINGS: Between March 14, 2017, and March 16, 2018 we recruited 285 participants. 16 patients were randomly allocated to the denosumab group, 15 to the combination group, and 15 to the placebo group. Dropout was limited to one patient in the combination group. Compared with placebo, BMD improved in groups receiving denosumab: lumbar spine (combination group 5·4% [95% CI 2·7-8·1], denosumab group 6·9% [95% CI 4·2-9·6]; p<0·0001), total hip (combination group 5·0% [3·0-6·9], denosumab group 4·1% [2·5-5·8]; p<0·0001), and femoral neck (combination group 4·5% [1·9-7·9]; p=0·0008, denosumab group 3·8% [1·4-6·3]; p=0·0022]). Changes in BMD at the third distal forearm were borderline significant. Six non-fatal serious adverse events occurred (combination group [n=2], denosumab group [n=1], placebo group [n=3]). The overall prevalence of adverse events did not differ between treatment groups, and no fatal adverse events occurred. INTERPRETATION: Evidence suggested denosumab was effective in improving BMD and lowering bone turnover in patients with primary hyperparathyroidism irrespective of cinacalcet treatment and might be a valid option for patients in which surgery is undesirable. FUNDING: Aalborg University Hospital and Aalborg University, Denmark.


Assuntos
Cinacalcete/uso terapêutico , Denosumab/uso terapêutico , Hiperparatireoidismo Primário/tratamento farmacológico , Idoso , Densidade Óssea/efeitos dos fármacos , Remodelação Óssea/efeitos dos fármacos , Cinacalcete/efeitos adversos , Denosumab/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
12.
Sci Rep ; 10(1): 5620, 2020 03 27.
Artigo em Inglês | MEDLINE | ID: mdl-32221325

RESUMO

Medication-related osteonecrosis of the jaw (MRONJ) occurs in patients undergoing oral surgery while medicated with bisphosphonate, denosumab or anti-angiogenic agents. We employed a MRONJ-like rat model to investigate whether injecting fluvastatin at extraction sites prevents MRONJ-like lesion. A MRONJ-like model was created by treating rats with zoledronate and dexamethasone, extracting teeth, and immediately injecting fluvastatin at the extraction site. The experimental group comprised three subgroups treated with low (0.1 mg/kg; FS-L), medium (1.0 mg/kg; FS-M) and high concentrations (10 mg/kg; FS-H) of fluvastatin. Necrotic bone exposure was significantly lower in the FS-M (p = 0.028) and FS-H (p = 0.041) groups than in the MRONJ group. The distance between the edges of the epithelial surfaces was significantly shorter in the FS-M (p = 0.042) and FS-H (p = 0.041) groups. The area of necrotic bone and the necrotic bone ratio were significantly smaller in the FS-H group (p = 0.041 and p = 0.042 respectively). Bone volume fraction calculated on µ-CT images was significantly larger in the FS-H group than in the MRONJ group (p = 0.021). Our findings suggest that a single local injection of fluvastatin following tooth extraction can potentially reduce the chance of developing MRONJ-like lesion in rats.


Assuntos
Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/prevenção & controle , Fluvastatina/farmacologia , Osteonecrose/prevenção & controle , Inibidores da Angiogênese/efeitos adversos , Animais , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/etiologia , Conservadores da Densidade Óssea/efeitos adversos , Osso e Ossos/diagnóstico por imagem , Denosumab/efeitos adversos , Difosfonatos/efeitos adversos , Modelos Animais de Doenças , Feminino , Osteonecrose/etiologia , Ratos , Ratos Wistar , Extração Dentária/efeitos adversos , Ácido Zoledrônico/efeitos adversos
14.
J Oncol Pharm Pract ; 26(5): 1180-1189, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32122232

RESUMO

While bone-modifying agents such as bisphosphonates and denosumab are crucial to preventing skeletal-related events in patients with bone metastases, the optimal duration remains undefined. Extended duration may be associated with adverse effects such as osteonecrosis of the jaw and atypical femoral fracture. Although uncommon, atypical femoral fracture represents a serious consequence of prolonged bone-modifying agent use and are characterized by a prodrome and distinct radiographic findings. The oncology setting encompasses a unique set of atypical femoral fracture risk factors and considerations, with hormonal therapy in early stage disease, bone metastases in the advanced setting, and new targeted agents that may affect bone homeostasis. As outcomes in cancer treatment continue to improve, the questions of risks versus benefits of long-term bone-modifying agents and how to mitigate atypical femoral fracture risk become increasingly pertinent.


Assuntos
Conservadores da Densidade Óssea/administração & dosagem , Neoplasias Ósseas/tratamento farmacológico , Difosfonatos/administração & dosagem , Fraturas do Fêmur/prevenção & controle , Conservadores da Densidade Óssea/efeitos adversos , Denosumab/administração & dosagem , Denosumab/efeitos adversos , Difosfonatos/efeitos adversos , Fraturas do Fêmur/induzido quimicamente , Humanos , Osteonecrose/induzido quimicamente , Osteonecrose/prevenção & controle , Fatores de Risco
15.
Drugs Aging ; 37(4): 311-320, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32026309

RESUMO

BACKGROUND AND OBJECTIVE: There is a relative lack of head-to-head comparisons of denosumab against other osteoporosis drugs on safety. We aimed to explore ocular outcomes in patients with osteoporosis initiating denosumab vs zoledronic acid. METHODS: We conducted a cohort study using claims data (2010-15) from two large US commercial insurance databases including patients with osteoporosis who were aged 50 years or older and initiators of denosumab or zoledronic acid. The primary outcomes were (1) receipt of cataract surgery and development of (2) wet age-related macular degeneration and (3) dry age-related macular degeneration within 365 days after initiation of denosumab vs zoledronic acid. Propensity score fine stratification and weighting were used to control for potential confounding, and we calculated the incidence rate and hazard ratio for each outcome in the cohorts. The estimates from the two databases were combined with a fixed-effects model meta-analysis. RESULTS: The study cohort included 50,821 denosumab and 67,471 zoledronic acid initiators. In the propensity score-weighted analysis, compared to zoledronic acid use, denosumab was associated with a modestly decreased risk of undergoing cataract surgery (hazard ratio 0.91; 95% confidence interval 0.85-0.98) but not with the risk of wet age-related macular degeneration (hazard ratio 1.29; 95% confidence interval 0.99-1.70) or dry age-related macular degeneration (hazard ratio 1.03; 95% confidence interval 0.98-1.09). CONCLUSIONS: In this large population-based cohort study of 118,292 patients with osteoporosis, initiation of denosumab was associated with a modestly decreased risk of cataract surgery vs zoledronic acid. The risk of age-related macular degeneration was similar between the two drugs.


Assuntos
Conservadores da Densidade Óssea/efeitos adversos , Extração de Catarata/estatística & dados numéricos , Bases de Dados Factuais , Denosumab/efeitos adversos , Degeneração Macular/induzido quimicamente , Osteoporose/tratamento farmacológico , Ácido Zoledrônico/efeitos adversos , Idoso , Conservadores da Densidade Óssea/uso terapêutico , Estudos de Coortes , Denosumab/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Risco , Ácido Zoledrônico/uso terapêutico
16.
Arch Osteoporos ; 15(1): 7, 2020 01 02.
Artigo em Inglês | MEDLINE | ID: mdl-31898803

RESUMO

Here, we report the case of a 69-year-old female who discontinued denosumab to undergo dental treatment. She subsequently suffered rebound-associated vertebral fractures (RVFs) twice. Denosumab is approved in several countries for osteoporosis treatment. Its discontinuation can result in bone turnover rebound increase and rapid bone mineral density loss. Rebound-associated vertebral fractures (RVFs) after discontinuing denosumab have been widely reported. We previously reported the case of a patient who suffered RVFs after discontinuing denosumab to undergo dental treatment. A 69-year-old female suffered five acute VFs 10 months after the last denosumab injection. The current report identifies the risks associated with denosumab discontinuation to undergo dental treatment. The patient described in this report also underwent an additional clinical course after the first RVFs. Next month after the first RVFs, she developed severe back pain when she changed her posture. Magnetic resonance imaging showed new RVFs at T9 and T12 levels. This case indicates that RVFs may occur more than once. In addition, it suggests that additional denosumab injections do not completely eliminate the risk of RVFs.


Assuntos
Conservadores da Densidade Óssea/efeitos adversos , Denosumab/efeitos adversos , Osteoporose Pós-Menopausa/tratamento farmacológico , Fraturas da Coluna Vertebral/induzido quimicamente , Síndrome de Abstinência a Substâncias/complicações , Idoso , Densidade Óssea , Remodelação Óssea/efeitos dos fármacos , Feminino , Humanos , Imagem por Ressonância Magnética , Osteoporose Pós-Menopausa/diagnóstico por imagem , Suspensão de Tratamento
17.
BMJ Case Rep ; 13(1)2020 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-31907213

RESUMO

In 2003, Marx reported the first case of osteonecrosis of the jaw in 36 cases related to zoledronic acid or pamidronate. Painful bone exposure in the mandible or maxilla unresponsive to medical or surgical management was observed. In 2014, the American Association of Oral and Maxillofacial Surgeons proposed the term 'medication-related osteonecrosis of the jaw' (MRONJ). However, a non-exposed variant may also occur. MRONJ can lead to debilitating clinical sequelae with limited treatment options. We present the case of a 73-year-old woman with metastatic breast cancer and MRONJ of her mandible and maxilla following treatment with intravenous zoledronic acid and denosumab. Six months following dental extractions, she was referred to the Department of Oral and Maxillofacial Surgery for assessment of extensive necrosis of her maxilla and mandible. Extraoral draining sinuses were observed. A CT mandible showed cortical destruction with an ill-defined mixed sclerotic-lucent pattern in keeping with osteonecrosis. Due to her metastatic breast cancer, the extent of her necrosis and poor performance status, free flap reconstruction of her mandible was ruled out. She was treated conservatively.


Assuntos
Combinação Amoxicilina e Clavulanato de Potássio/uso terapêutico , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/terapia , Conservadores da Densidade Óssea/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Denosumab/efeitos adversos , Idoso , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/diagnóstico por imagem , Diagnóstico Diferencial , Evolução Fatal , Feminino , Humanos , Mandíbula , Maxila , Tomografia Computadorizada por Raios X , Extração Dentária
18.
Med. oral patol. oral cir. bucal (Internet) ; 25(1): e71-e83, ene. 2020. tab, ilus
Artigo em Inglês | IBECS | ID: ibc-196198

RESUMO

BACKGROUND: Medication-related osteonecrosis of the jaw (MRONJ) is a rare, but serious adverse effect of certain drugs, of which bisphosphonates are the most widely known. This pathology is also associated with other medications such as the biologic antiresorptive agent, denosumab and some antiangiogenics such as sunitinib, bevacizumab or aflibercept. Very recently, new medications have also been associated with osteonecrosis of the jaw (ONJ). The objectives were to update the list of medications associated with ONJ, to analyze the fundamental aspects of this list and to describe the level of evidence available. MATERIAL AND METHODS: A narrative bibliographic review was made, using the PubMed-MedLine, DOAJ and SCI-ELO databases. Additional information was obtained through the online Medication Information Centre of the Spanish Agency of Medicines and Medical Devices (AEMPS - CIMA), the websites of the US Food & Drugs Administration (Drugs@FDA) and the European Medicines Agency (EMA). RESULTS: The latest drugs identified as potential facilitators of this pathology include a number of anti-VEGF based antiangiogenic drugs and anti-TKI and different types of immunomodulators. Neither the level of evidence in this association nor the risk are equal for all these drugs. On the other hand, over the coming years, new drugs will be marketed with similar action mechanisms to those that are recognized as having this adverse effect. CONCLUSIONS: No effective therapy is currently known for the treatment of ONJ. Therefore, in order to prevent new cases of MRONJ, it is essential for all oral healthcare professionals to be fully up-to-date with the etiopathogenic aspects of this pathology and to be aware of those drugs considered to be a risk


No disponible


Assuntos
Humanos , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/etiologia , Conservadores da Densidade Óssea/efeitos adversos , Inibidores da Angiogênese/efeitos adversos , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/prevenção & controle , Fatores de Risco , Denosumab/efeitos adversos , Bevacizumab/efeitos adversos , Sunitinibe/efeitos adversos
20.
Breast Cancer Res Treat ; 179(1): 153-159, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31598815

RESUMO

PURPOSE: At denosumab discontinuation, bone turnover markers increase and the gained BMD is lost. In postmenopausal osteoporosis, there is an increased risk of spontaneous vertebral fractures (VFs) of about 1 to 10%, rarely described in women under denosumab for aromatase inhibitors (AI)-treated breast cancer. We aim to describe the characteristics of 15 patients under denosumab given for AI-treated early-stage breast cancer that presented VFs at its discontinuation. METHODS: Single-center retrospective case series of 15 patients. We report clinical data, dual X-ray absorptiometry values at denosumab initiation and discontinuation, and serum B-crosslaps dosage at the time of VF occurrence (before denosumab resumption). RESULTS: Fifteen women (66.4 ± 7.1 years at denosumab discontinuation) that received AI for 5.0 ± 0.6 years, denosumab 60 mg for 8.2 ± 2.0 doses, and developed 60 VFs at denosumab discontinuation, were followed for 24.4 ± 9.5 months. Patients suffered from 1 to 11 (mean 4.0 ± 1.9) clinical VFs within 7 to 16 months after last denosumab injection. VFs developed earlier in patients with longer denosumab treatment (R2 = 0.29, p = 0.04) and in patients without osteoporosis before denosumab (9.4 ± 2.0 vs. 13.0 ± 2.0 months; p = 0.005). Serum B-crosslaps at the time of VFs tended to be higher in patients with earlier VFs (R2 = 0.47; p = 0.06) or with longer denosumab treatment (R2 = 0.48; p = 0.06). Denosumab was resumed in all patients, then switched for a bisphosphonate in eight. No new VFs occurred during follow-up. CONCLUSIONS: Despite an apparently low fracture risk, women under denosumab for AI-treated early-stage breast cancer develop spontaneous VFs at denosumab discontinuation. This risk increases with treatment duration and may be prevented by a potent bisphosphonate.


Assuntos
Inibidores da Aromatase/uso terapêutico , Conservadores da Densidade Óssea/administração & dosagem , Neoplasias da Mama/tratamento farmacológico , Denosumab/administração & dosagem , Fraturas Ósseas/epidemiologia , Absorciometria de Fóton , Idoso , Inibidores da Aromatase/efeitos adversos , Conservadores da Densidade Óssea/efeitos adversos , Neoplasias da Mama/patologia , Denosumab/efeitos adversos , Difosfonatos/uso terapêutico , Feminino , Fraturas Ósseas/induzido quimicamente , Humanos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Estudos Retrospectivos , Resultado do Tratamento
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