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Calcium & bone metabolism
Persistence with Denosumab in Male Osteoporosis Patients: A Real-World, Non-Interventional Multicenter Study
Chaiho Jeong, Jeongmin Lee, Jinyoung Kim, Jeonghoon Ha, Kwanhoon Jo, Yejee Lim, Mee Kyoung Kim, Hyuk-Sang Kwon, Tae-Seo Sohn, Ki-Ho Song, Moo Il Kang, Ki-Hyun Baek
Endocrinol Metab. 2023;38(2):260-268.   Published online April 27, 2023
DOI: https://doi.org/10.3803/EnM.2023.1663
  • 1,702 View
  • 106 Download
  • 1 Crossref
AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
Background
Persistence with denosumab in male patients has not been adequately investigated, although poor denosumab persistence is associated with a significant risk of rebound vertebral fractures.
Methods
We retrospectively evaluated 294 Korean male osteoporosis patients treated with denosumab at three medical centers and examined their persistence with four doses of denosumab injection over 24 months of treatment. Persistence was defined as the extent to which a patient adhered to denosumab treatment in terms of the prescribed interval and dose, with a permissible gap of 8 weeks. For patients who missed their scheduled treatment appointment(s) during the follow-up period (i.e., no-shows), Cox proportional regression analysis was conducted to explore the factors associated with poor adherence. Several factors were considered, such as age, prior anti-osteoporotic drug use, the treatment provider’s medical specialty, the proximity to the medical center, and financial burdens of treatment.
Results
Out of 294 male patients, 77 (26.2%) completed all four sequential rounds of the denosumab treatment. Out of 217 patients who did not complete the denosumab treatment, 138 (63.6%) missed the scheduled treatment(s). Missing treatment was significantly associated with age (odds ratio [OR], 1.03), prior bisphosphonate use (OR, 0.76), and prescription by non-endocrinologists (OR, 2.24). Denosumab was stopped in 44 (20.3%) patients due to medical errors, in 24 (11.1%) patients due to a T-score improvement over –2.5, and in five (2.3%) patients due to expected dental procedures.
Conclusion
Our study showed that only one-fourth of Korean male osteoporosis patients were fully adherent to 24 months of denosumab treatment.

Citations

Citations to this article as recorded by  
  • Denosumab

    Reactions Weekly.2023; 1963(1): 206.     CrossRef
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Calcium & Bone Metabolism
Real-World Safety and Effectiveness of Denosumab in Patients with Osteoporosis: A Prospective, Observational Study in South Korea
Yumie Rhee, Dong-Gune Chang, Jeonghoon Ha, Sooa Kim, Yusun Lee, Euna Jo, Jung-Min Koh
Endocrinol Metab. 2022;37(3):497-505.   Published online June 3, 2022
DOI: https://doi.org/10.3803/EnM.2022.1427
  • 5,265 View
  • 263 Download
  • 8 Web of Science
  • 8 Crossref
AbstractAbstract PDFPubReader   ePub   
Background
The efficacy and safety of denosumab have been established in a phase 3, randomized, placebo-controlled trial in Korean postmenopausal women with osteoporosis. This postmarketing surveillance study was aimed to investigate the safety and effectiveness of denosumab in Korean real-world clinical practice.
Methods
Patients with osteoporosis who had received denosumab per the Korean approved indications in the postmarketing setting between September 2014 and September 2019 were enrolled. The primary endpoint was the incidence of adverse events (AEs) and adverse drug reactions (ADRs). The secondary endpoint was the percent change from baseline in bone mineral density (BMD) of the lumbar spine, total hip, and femoral neck.
Results
Of the 3,221 patients enrolled, 3,185 were included in the safety analysis set; 2,973 (93.3%) were female, and the mean± standard deviation (SD) age was 68.9±9.9 years. The mean±SD study period was 350.0±71.4 days. AEs, fatal AEs, and ADRs occurred in 19.3%, 0.8%, and 1.6%, respectively. The most frequent AEs, occurring in >0.5% of patients, were dizziness (0.7%), arthralgia (0.7%), back pain (0.6%), and myalgia (0.6%). Hypocalcemia occurred in 0.3% of patients. There were no cases of osteonecrosis of the jaw and atypical femoral fracture. Mean±SD percent change from baseline in BMD of the lumbar spine, total hip, and femoral neck was 7.3%±23.6%, 3.6%±31.4%, and 3.2%±10.7%, respectively.
Conclusion
The safety and effectiveness of denosumab in Korean patients with osteoporosis in this study were comparable with those in the Korean randomized controlled trial, with no new safety findings.

Citations

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  • Prevalence of denosumab-induced hypocalcemia: a retrospective observational study of patients routinely monitored with ionized calcium post-injection
    Anna Spångeus, Johan Rydetun, Mischa Woisetschläger
    Osteoporosis International.2024; 35(1): 173.     CrossRef
  • Cost-consequence analysis of continuous denosumab therapy for osteoporosis treatment in South Korea
    Seungju Cha, Minjeong Sohn, Hyowon Yang, Eric J. Yeh, Ki-Hyun Baek, Jeonghoon Ha, Hyemin Ku
    BMC Musculoskeletal Disorders.2024;[Epub]     CrossRef
  • Denosumab and the Risk of Diabetes in Patients Treated for Osteoporosis
    Huei-Kai Huang, Albert Tzu-Ming Chuang, Tzu-Chi Liao, Shih-Chieh Shao, Peter Pin-Sung Liu, Yu-Kang Tu, Edward Chia-Cheng Lai
    JAMA Network Open.2024; 7(2): e2354734.     CrossRef
  • Adverse Effects of Denosumab in Kidney Transplant Recipients: A 20-Year Retrospective Single-Center Observation Study in Central Taiwan
    Tsung-Yin Tsai, Zi-Hong You, Shang-Feng Tsai, Ming-Ju Wu, Tung-Min Yu, Ya-Wen Chuang, Yung-Chieh Lin, Ya-Lian Deng, Chiann-Yi Hsu, Cheng-Hsu Chen
    Transplantation Proceedings.2023; 55(4): 837.     CrossRef
  • Persistence with Denosumab in Male Osteoporosis Patients: A Real-World, Non-Interventional Multicenter Study
    Chaiho Jeong, Jeongmin Lee, Jinyoung Kim, Jeonghoon Ha, Kwanhoon Jo, Yejee Lim, Mee Kyoung Kim, Hyuk-Sang Kwon, Tae-Seo Sohn, Ki-Ho Song, Moo Il Kang, Ki-Hyun Baek
    Endocrinology and Metabolism.2023; 38(2): 260.     CrossRef
  • Effect of Denosumab on Bone Density in Postmenopausal Osteoporosis: A Comparison with and without Calcium Supplementation in Patients on Standard Diets in Korea
    Chaiho Jeong, Jinyoung Kim, Jeongmin Lee, Yejee Lim, Dong-Jun Lim, Ki-Hyun Baek, Jeonghoon Ha
    Journal of Clinical Medicine.2023; 12(21): 6904.     CrossRef
  • Denosumab

    Reactions Weekly.2022; 1919(1): 221.     CrossRef
  • Denosumab, an effective osteoporosis treatment option for men
    Sung Hye Kong
    The Korean Journal of Internal Medicine.2022; 37(5): 947.     CrossRef
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Review Articles
Calcium & Bone Metabolism
Discontinuing Denosumab: Can It Be Done Safely? A Review of the Literature
Wei Lin Tay, Donovan Tay
Endocrinol Metab. 2022;37(2):183-194.   Published online April 14, 2022
DOI: https://doi.org/10.3803/EnM.2021.1369
  • 15,965 View
  • 888 Download
  • 2 Web of Science
  • 2 Crossref
AbstractAbstract PDFPubReader   ePub   
Denosumab, which has been approved for the treatment of osteoporosis since 2010, is a fully humanised monoclonal antibody against a cytokine, receptor activator of nuclear factor kappa B ligand (RANKL), involved in bone resorption. Continued use of denosumab results in a potent and sustained decrease in bone turnover, an increase in bone mineral density (BMD), and a reduction in vertebral and hip fractures. The anti-resorptive effects of denosumab are reversible upon cessation, and this reversal is accompanied by a transient marked increase in bone turnover that is associated with bone loss, and of concern, an increased risk of multiple vertebral fractures. In this review, we outline the effects of denosumab withdrawal on bone turnover markers, BMD, histomorphometry, and fracture risk. We provide an update on recent clinical trials that sought to answer how clinicians can transition away from denosumab safely with follow-on therapy to mitigate bone loss and summarise the recommendations of various international guidelines.

Citations

Citations to this article as recorded by  
  • Loss of lower extremity bone mineral density 1 year after denosumab is discontinued in persons with subacute spinal cord injury
    Christopher M. Cirnigliaro, Michael F. La Fountaine, J. Scott Parrott, Steven C. Kirshblum, Susan J. Sauer, Sue A. Shapses, Isa A. McClure, William A. Bauman
    Osteoporosis International.2023; 34(4): 741.     CrossRef
  • Persistence with Denosumab in Male Osteoporosis Patients: A Real-World, Non-Interventional Multicenter Study
    Chaiho Jeong, Jeongmin Lee, Jinyoung Kim, Jeonghoon Ha, Kwanhoon Jo, Yejee Lim, Mee Kyoung Kim, Hyuk-Sang Kwon, Tae-Seo Sohn, Ki-Ho Song, Moo Il Kang, Ki-Hyun Baek
    Endocrinology and Metabolism.2023; 38(2): 260.     CrossRef
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Calcium & Bone Metabolism
Review and Update of the Risk Factors and Prevention of Antiresorptive-Related Osteonecrosis of the Jaw
Ha Young Kim
Endocrinol Metab. 2021;36(5):917-927.   Published online October 21, 2021
DOI: https://doi.org/10.3803/EnM.2021.1170
  • 4,384 View
  • 267 Download
  • 8 Web of Science
  • 10 Crossref
AbstractAbstract PDFPubReader   ePub   
Antiresorptive-related osteonecrosis of the jaw (ARONJ) is a rare but serious adverse event of bisphosphonate or denosumab administration; it is associated with severe pain and a deteriorated quality of life. Since its first report in 2003, there have been many studies on its definition, epidemiology, pathophysiology, diagnosis, and treatment. Nevertheless, the epidemiology and mechanisms underlying this condition have not yet been fully delineated and several risk factors are known. Moreover, as there is no effective treatment currently available for osteonecrosis of the jaw, prevention is essential. Furthermore, close cooperation between prescribing physicians and dentists is important. The aim of this review was to provide up-to-date information regarding the risk factors and prevention of ARONJ from a physician’s perspective.

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    Frontiers in Immunology.2024;[Epub]     CrossRef
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    Eirena L. Goulden, Rachel K. Crowley
    Clinical Endocrinology.2023; 98(5): 649.     CrossRef
  • Clinical and Histopathological Aspects of MRONJ in Cancer Patients
    George Adrian Ciobanu, Laurențiu Mogoantă, Adrian Camen, Mihaela Ionescu, Daniel Vlad, Ionela Elisabeta Staicu, Cristina Maria Munteanu, Mircea Ionuț Gheorghiță, Răzvan Mercuț, Elena Claudia Sin, Sanda Mihaela Popescu
    Journal of Clinical Medicine.2023; 12(10): 3383.     CrossRef
  • Bisphosphonates and osteonecrosis of the jaws: Clinical and forensic aspects
    Diana Nogueira, Inês Morais Caldas, Ricardo Jorge Dinis-Oliveira
    Archives of Oral Biology.2023; 155: 105792.     CrossRef
  • Correlations between Immune Response and Etiopathogenic Factors of Medication-Related Osteonecrosis of the Jaw in Cancer Patients Treated with Zoledronic Acid
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  • Analysis of the Degree of Information of Dental Surgeons about Antiresorptive Drugs According to the Time Since Graduation in Dentistry
    Flávia Godinho Costa Wanderley Rocha, Roberto Paulo Correia de Araújo
    Pesquisa Brasileira em Odontopediatria e Clínica Integrada.2023;[Epub]     CrossRef
  • Safety and Efficacy of Pamidronate in Neonatal Hypercalcemia Caused by Subcutaneous Fat Necrosis: A Case Report
    Stefano Martinelli, Marco Pitea, Italo Francesco Gatelli, Tara Raouf, Graziano Barera, Ottavio Vitelli
    Frontiers in Pediatrics.2022;[Epub]     CrossRef
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    S. S. Rodionova, A. F. Kolondaev, A. N. Torgashin, I. A. Solomyannik
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Bone Metabolism
Long-Term Treatment of Postmenopausal Osteoporosis
Jacques P. Brown
Endocrinol Metab. 2021;36(3):544-552.   Published online June 22, 2021
DOI: https://doi.org/10.3803/EnM.2021.301
  • 14,432 View
  • 918 Download
  • 37 Web of Science
  • 35 Crossref
AbstractAbstract PDFPubReader   ePub   
Osteoporosis is an incurable chronic condition, like heart disease, diabetes, or hypertension. A large gap currently exists in the primary prevention of fractures, and studies show that an estimated 80% to 90% of adults do not receive appropriate osteoporosis management even in the secondary prevention setting. Case finding strategies have been developed and effective pharmacological interventions are available. This publication addresses how best to use the pharmacological options available for postmenopausal osteoporosis to provide lifelong fracture protection in patients at high and very high risk of fracture. The benefit of osteoporosis therapies far outweighs the rare risks.

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Close layer
Bone Metabolism
Update on Denosumab Treatment in Postmenopausal Women with Osteoporosis
Yong-Ki Min
Endocrinol Metab. 2015;30(1):19-26.   Published online March 27, 2015
DOI: https://doi.org/10.3803/EnM.2015.30.1.19
  • 3,743 View
  • 38 Download
  • 16 Web of Science
  • 15 Crossref
AbstractAbstract PDFPubReader   

Denosumab, a fully human recombinant monoclonal antibody to the receptor activator of nuclear factor-κB ligand (RANKL), blocks binding of RANKL to the RANK receptor, found on the surface of osteoclasts and osteoclast precursors, resulting in decreased bone resorption. Subcutaneous denosumab administration once every 6 months increases bone mineral density at the lumbar spine, total hip, and/or femoral neck, and reduces markers of bone turnover significantly in postmenopausal women with osteoporosis. Relative to placebo, denosumab treatment reduces the risk of vertebral, nonvertebral, and hip fractures significantly. The benefits of denosumab treatment are generally obvious after the first dose and were continued for up to 8 years of treatment in an extension study. The tolerability profile of denosumab during this extension phase was consistent with that observed during the initial 3-year FREEDOM trial. Postmarketing safety surveillance has not shown any unexpected findings. Ongoing safety surveillance will more fully define the long-term safety of denosumab. The benefits of denosumab would seem to be greater than its risks. Denosumab is an important choice in the treatment of postmenopausal women with osteoporosis at increased risk of fractures, including older patients who have difficulty with oral bisphosphonate intake and patients who are intolerant of, or unresponsive to, other therapies.

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