Endocrinology and Metabolism

Original Articles

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

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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

Adrenal Gland
Outcome-Based Decision-Making Algorithm for Treating Patients with Primary Aldosteronism: Jung Hee Kim, Chang Ho Ahn, Su Jin Kim, Kyu Eun Lee, Jong Woo Kim, Hyun-Ki Yoon, Yu-Mi Lee, Tae-Yon Sung, Sang Wan Kim, Chan Soo Shin, Jung-Min Koh, Seung Hun Lee; Endocrinol Metab. 2022;37(2):369-382. Published online April 14, 2022; DOI: https://doi.org/10.3803/EnM.2022.1391

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Background
Optimal management of primary aldosteronism (PA) is crucial due to the increased risk of cardiovascular and cerebrovascular diseases. Adrenal venous sampling (AVS) is the gold standard method for determining subtype but is technically challenging and invasive. Some PA patients do not benefit clinically from surgery. We sought to develop an algorithm to improve decision- making before engaging in AVS and surgery in clinical practice.
Methods
We conducted the ongoing Korean Primary Aldosteronism Study at two tertiary centers. Study A involved PA patients with successful catheterization and a unilateral nodule on computed tomography and aimed to predict unilateral aldosterone-producing adenoma (n=367). Study B involved similar patients who underwent adrenalectomy and aimed to predict postoperative outcome (n=330). In study A, we implemented important feature selection using the least absolute shrinkage and selection operator regression.
Results
We developed a unilateral PA prediction model using logistic regression analysis: lowest serum potassium level ≤3.4 mEq/L, aldosterone-to-renin ratio ≥150, plasma aldosterone concentration ≥30 ng/mL, and body mass index <25 kg/m2 (area under the curve, 0.819; 95% confidence interval, 0.774 to 0.865; sensitivity, 97.6%; specificity, 25.5%). In study B, we identified female, hypertension duration <5 years, anti-hypertension medication <2.5 daily defined dose, and the absence of coronary artery disease as predictors of clinical success, using stepwise logistic regression models (sensitivity, 94.2%; specificity, 49.3%). We validated our algorithm in the independent validation dataset (n=53).
Conclusion
We propose this new outcome-driven diagnostic algorithm, simultaneously considering unilateral aldosterone excess and clinical surgical benefits in PA patients.

Citations

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Subtype-specific Body Composition and Metabolic Risk in Patients With Primary Aldosteronism
Seung Shin Park, Chang Ho Ahn, Sang Wan Kim, Ji Won Yoon, Jung Hee Kim
The Journal of Clinical Endocrinology & Metabolism.2024; 109(2): e788. CrossRef
Prognostic models to predict complete resolution of hypertension after adrenalectomy in primary aldosteronism: A systematic review and meta‐analysis
Luigi Marzano, Amir Kazory, Faeq Husain‐Syed, Claudio Ronco
Clinical Endocrinology.2023; 99(1): 17. CrossRef
2023 Korean Endocrine Society Consensus Guidelines for the Diagnosis and Management of Primary Aldosteronism
Jeonghoon Ha, Jung Hwan Park, Kyoung Jin Kim, Jung Hee Kim, Kyong Yeun Jung, Jeongmin Lee, Jong Han Choi, Seung Hun Lee, Namki Hong, Jung Soo Lim, Byung Kwan Park, Jung-Han Kim, Kyeong Cheon Jung, Jooyoung Cho, Mi-kyung Kim, Choon Hee Chung
Endocrinology and Metabolism.2023; 38(6): 597. CrossRef
Correlation of Histopathologic Subtypes of Primary Aldosteronism with Clinical Phenotypes and Postsurgical Outcomes
Chang Ho Ahn, You-Bin Lee, Jae Hyeon Kim, Young Lyun Oh, Jung Hee Kim, Kyeong Cheon Jung
The Journal of Clinical Endocrinology & Metabolism.2023;[Epub] CrossRef

Response

Adrenal Gland
Diagnostic Accuracy of Computed Tomography in Predicting Primary Aldosteronism Subtype According to Age (Endocrinol Metab 2021;36:401-12, Seung Hun Lee et al.): Seung Hun Lee, Jong Woo Kim, Hyun-Ki Yoon, Jung-Min Koh, Chan Soo Shin, Sang Wan Kim, Jung Hee Kim; Endocrinol Metab. 2021;36(4):914-915. Published online August 27, 2021; DOI: https://doi.org/10.3803/EnM.2021.402; [Original]

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Citations

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Strategies for subtyping primary aldosteronism
Yun-Hsuan Yang, Yu-Ling Chang, Bo-Ching Lee, Ching-Chu Lu, Wei-Ting Wang, Ya-Hui Hu, Han-Wen Liu, Yung-Hsiang Lin, Chin-Chen Chang, Wan-Chen Wu, Fen-Yu Tseng, Yen-Hung Lin, Vin-Cent Wu, Chii-Min Hwu
Journal of the Formosan Medical Association.2024; 123: S114. CrossRef
Diagnostic consistency between computed tomography and adrenal vein sampling of primary aldosteronism: leading to successful curative outcome after adrenalectomy; a retrospective study
Byung-Chang Kim, Hyun-Ki Yoon, Kye Jin Park, Gun Ha Kim, Shin Jeong Pak, Douk Kwon, Jae Won Cho, Won Woong Kim, Yu-Mi Lee, Jung-Min Koh, Seung Hun Lee, Ki-Wook Chung, Tae-Yon Sung
International Journal of Surgery.2024; 110(2): 839. CrossRef

Original Articles

Adrenal Gland
Contralateral Suppression at Adrenal Venous Sampling Is Associated with Renal Impairment Following Adrenalectomy for Unilateral Primary Aldosteronism: Ye Seul Yang, Seung Hun Lee, Jung Hee Kim, Jee Hee Yoo, Jung Hyun Lee, Seo Young Lee, A Ram Hong, Dong-Hwa Lee, Jung-Min Koh, Jae Hyeon Kim, Sang Wan Kim; Endocrinol Metab. 2021;36(4):875-884. Published online August 11, 2021; DOI: https://doi.org/10.3803/EnM.2021.1047

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Background
Adrenal venous sampling (AVS) is performed to distinguish the subtype of primary aldosteronism (PA). The clinical implication of contralateral suppression (CS; aldosterone/cortisol_nondominantperipheral) at AVS remains unclear. We aimed to investigate the clinical significance of CS and its impact on postoperative outcomes after unilateral adrenalectomy.
Methods
In this retrospective observational multi-center study, we analyzed PA patients who underwent both successful adrenocorticotropin hormone-stimulated AVS and unilateral adrenalectomy. Successful cannulation was defined as the selectivity index (cortisol_adrenal/ cortisol_peripheral) ≥3. Clinical and biochemical outcomes after unilateral adrenalectomy were evaluated based on the international Primary Aldosteronism Surgical Outcome consensus.
Results
Among 263 patients analyzed, 247 had CS (93.9%). Patients with CS had lower serum potassium levels, higher plasma aldosterone concentration, higher aldosterone-to-renin ratio (ARR), and larger adenoma size than those without CS. Those with CS showed significantly higher lateralization index than those without CS (P<0.001). Although postoperative blood pressure and ARR significantly decreased in those with CS, clinical and biochemical outcomes were comparable in both groups. When the cut-off value of age was determined using receiver operating characteristic (ROC) analysis, patients aged ≥50 years old with contralateral suppression index (CSI; the ratio between aldosterone/cortisol_nondominant and aldosterone/cortisol_peripheral) ≤0.26 had greater odds ratio (6.43; 95% confidence interval, 1.30 to 31.69) of incident chronic kidney disease than those aged <50 years with CSI >0.26 after adjusting for other factors.
Conclusion
CS may not predict postoperative clinical and biochemical outcomes in subjects with unilateral aldosterone excess, but it is associated with postsurgical deterioration of renal function in subjects over 50 years with CSI ≤0.26.

Citations

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Treatment decision based on unilateral index from nonadrenocorticotropic hormone-stimulated and adrenocorticotropic hormone-stimulated adrenal vein sampling in primary aldosteronism
Xizi Zhang, Xiaoyu Shu, Feifei Wu, Jun Yang, Qingfeng Cheng, Zhipeng Du, Ying Song, Yi Yang, Jinbo Hu, Yue Wang, Qifu Li, Shumin Yang
Journal of Hypertension.2024; 42(3): 450. CrossRef
Prognostic value of contralateral suppression on kidney function after surgery in patients with primary aldosteronism
Nathalie Voss, Sara Mørup, Caroline Clausen, Claus larsen Feltoft, Jan Viberg Jepsen, Mads Hornum, Mikkel Andreassen, Jesper Krogh
Clinical Endocrinology.2023; 98(3): 306. CrossRef
Factors Predicting Long-term Estimated Glomerular Filtration Rate Decrease, a Reliable Indicator of Renal Function After Adrenalectomy in Primary Aldosteronism
Qiyu He, Zhimin Tan, Yu Liu, Liang Zhou
Endocrine Practice.2023; 29(3): 199. CrossRef
Correlation of Histopathologic Subtypes of Primary Aldosteronism with Clinical Phenotypes and Postsurgical Outcomes
Chang Ho Ahn, You-Bin Lee, Jae Hyeon Kim, Young Lyun Oh, Jung Hee Kim, Kyeong Cheon Jung
The Journal of Clinical Endocrinology & Metabolism.2023;[Epub] CrossRef
Prognostic value of contralateral suppression for remission after surgery in patients with primary aldosteronism
Sara Mørup, Nathalie Voss, Caroline Clausen, Claus Larsen Feltoft, Mikkel Andreassen, Jesper Krogh
Clinical Endocrinology.2022; 96(6): 793. CrossRef
Contralateral Suppression at Adrenal Venous Sampling Is Associated with Renal Impairment Following Adrenalectomy for Unilateral Primary Aldosteronism (Endocrinol Metab 2021;36:875-84, Ye Seul Yang et al.)
Zhimin Tan, Qiyu He, Liang Zhou
Endocrinology and Metabolism.2022; 37(6): 951. CrossRef
Contralateral Suppression at Adrenal Venous Sampling Is Associated with Renal Impairment Following Adrenalectomy for Unilateral Primary Aldosteronism (Endocrinol Metab 2021;36:875-84, Ye Seul Yang et al.)
Ye Seul Yang, Sang Wan Kim
Endocrinology and Metabolism.2022; 37(6): 953. CrossRef

Clinical Study
Diagnostic Accuracy of Computed Tomography in Predicting Primary Aldosteronism Subtype According to Age: Seung Hun Lee, Jong Woo Kim, Hyun-Ki Yoon, Jung-Min Koh, Chan Soo Shin, Sang Wan Kim, Jung Hee Kim; Endocrinol Metab. 2021;36(2):401-412. Published online March 31, 2021; DOI: https://doi.org/10.3803/EnM.2020.901

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Background
Guidelines by the Endocrine Society Guideline on bypassing adrenal vein sampling (AVS) in patients <35 years old with marked primary aldosteronism (PA) (hypokalemia and elevated plasma aldosterone concentration [PAC]) and a unilateral lesion on computed tomography (CT) are based on limited number of studies. We aimed to determine the accuracy of CT in PA patients according to age.
Methods
In this retrospective study, we investigated the concordance between CT and AVS in 466 PA patients from two tertiary centers who successfully underwent AVS.
Results
CT had an overall accuracy of 64.4% (300/466). In the group with unilateral lesion, patients with hypokalemia had higher concordance than those without hypokalemia (85.0% vs. 43.6%, P<0.001). In the group with marked PA (hypokalemia and PAC >15.9 ng/dL) and unilateral lesion, accuracy of CT was 84.6% (11/13) in patients aged <35 years; 100.0% (20/20), aged 35 to 39 years; 89.4% (59/66), aged 40 to 49 years; and 79.8% (79/99), aged ≥50 years. Cut-off age and PAC for concordance was <50 years and >29.6 ng/dL, respectively. The significant difference in accuracy of CT in 198 patients with marked PA and a unilateral lesion between the <50-year age group and ≥50-year age group (90.9% vs. 79.8%, P=0.044) disappeared in 139 of 198 patients with PAC > 30.0 ng/dL (91.9% vs. 87.7%, P=0.590).
Conclusion
Patients with hypokalemia, PAC >30.0 ng/dL, and unilateral lesion were at high risk of unilateral PA regardless of age.

Citations

Citations to this article as recorded by

Predicting Bilateral Subtypes of Primary Aldosteronism Without Adrenal Vein Sampling: A Systematic Review and Meta-analysis
Elisabeth Ng, Stella May Gwini, Winston Zheng, Peter J Fuller, Jun Yang
The Journal of Clinical Endocrinology & Metabolism.2024; 109(2): e837. CrossRef
Subtype-specific Body Composition and Metabolic Risk in Patients With Primary Aldosteronism
Seung Shin Park, Chang Ho Ahn, Sang Wan Kim, Ji Won Yoon, Jung Hee Kim
The Journal of Clinical Endocrinology & Metabolism.2024; 109(2): e788. CrossRef
Imaging Concordance With Vein Sampling for Primary Aldosteronism: A Cohort Study and Literature Review
Sara Cartwright, MaKayla Gordon, Jessica Shank, Abbey Fingeret
Journal of Surgical Research.2024; 296: 1. CrossRef
Best Practices: Indications and Procedural Controversies of Adrenal Vein Sampling for Primary Aldosteronism
Keith B. Quencer, Abhilasha Singh, Anu Sharma
American Journal of Roentgenology.2023; 220(2): 190. CrossRef
Accuracy of Gallium-68 Pentixafor Positron Emission Tomography–Computed Tomography for Subtyping Diagnosis of Primary Aldosteronism
Jinbo Hu, Tingting Xu, Hang Shen, Ying Song, Jun Yang, Aipin Zhang, Haoyuan Ding, Naiguo Xing, Zhuoyuan Li, Lin Qiu, Linqiang Ma, Yi Yang, Zhengping Feng, Zhipeng Du, Wenwen He, Yue Sun, Jun Cai, Qifu Li, Yue Chen, Shumin Yang, Mei Mei, Suxin Luo, Kangla
JAMA Network Open.2023; 6(2): e2255609. CrossRef
Adrenal Vein Sampling in the Young – Necessary or Not?
Eleftheria Gkaniatsa, Oskar Ragnarsson
Experimental and Clinical Endocrinology & Diabetes.2023; 131(07/08): 435. CrossRef
2023 Korean Endocrine Society Consensus Guidelines for the Diagnosis and Management of Primary Aldosteronism
Jeonghoon Ha, Jung Hwan Park, Kyoung Jin Kim, Jung Hee Kim, Kyong Yeun Jung, Jeongmin Lee, Jong Han Choi, Seung Hun Lee, Namki Hong, Jung Soo Lim, Byung Kwan Park, Jung-Han Kim, Kyeong Cheon Jung, Jooyoung Cho, Mi-kyung Kim, Choon Hee Chung
Endocrinology and Metabolism.2023; 38(6): 597. CrossRef
Correlation of Histopathologic Subtypes of Primary Aldosteronism with Clinical Phenotypes and Postsurgical Outcomes
Chang Ho Ahn, You-Bin Lee, Jae Hyeon Kim, Young Lyun Oh, Jung Hee Kim, Kyeong Cheon Jung
The Journal of Clinical Endocrinology & Metabolism.2023;[Epub] CrossRef
Indices of ACTH‐stimulated adrenal venous sampling as predictors of postsurgical outcomes in primary aldosteronism
Seung Hun Lee, Jong Woo Kim, Hyun‐Ki Yoon, Sang Wan Kim, Su Jin Kim, Kyu Eun Lee, Yu‐Mi Lee, Tae‐Yon Sung, Suck Joon Hong, Chan Soo Shin, Jung‐Min Koh, Jung Hee Kim
Clinical Endocrinology.2022; 96(4): 521. CrossRef
Expression of CYP11B1 and CYP11B2 in adrenal adenoma correlates with clinical characteristics of primary aldosteronism
Chang Ho Ahn, Hee Young Na, So Yeon Park, Hyeong Won Yu, Su‐Jin Kim, June Young Choi, Kyu Eun Lee, Sang Wan Kim, Kyeong Cheon Jung, Jung Hee Kim
Clinical Endocrinology.2022; 96(1): 30. CrossRef
Letter to the Editor From Singhania et al: “Increasing Incidence of Primary Aldosteronism in Western Sweden During 3 Decades—Yet an Underdiagnosed Disorder”
Pankaj Singhania, Rana Bhattacharjee
The Journal of Clinical Endocrinology & Metabolism.2022; 107(3): e1315. CrossRef
Development and validation of model for sparing adrenal venous sampling in diagnosing unilateral primary aldosteronism
Ying Song, Jun Yang, Hang Shen, Elisabeth Ng, Peter J. Fuller, Zhengping Feng, Jinbo Hu, Linqiang Ma, Yi Yang, Zhipeng Du, Yue Wang, Ting Luo, Wenwen He, Qifu Li, Fei-Fei Wu, Shumin Yang
Journal of Hypertension.2022; 40(9): 1692. CrossRef
Validation of Existing Clinical Prediction Tools for Primary Aldosteronism Subtyping
Barbora Kološová, Petr Waldauf, Dan Wichterle, Jan Kvasnička, Tomáš Zelinka, Ondřej Petrák, Zuzana Krátká, Lubomíra Forejtová, Jan Kaván, Jiří Widimský, Robert Holaj
Diagnostics.2022; 12(11): 2806. CrossRef
Fully automatic volume measurement of the adrenal gland on CT using deep learning to classify adrenal hyperplasia
Taek Min Kim, Seung Jae Choi, Ji Yeon Ko, Sungwan Kim, Chang Wook Jeong, Jeong Yeon Cho, Sang Youn Kim, Young-Gon Kim
European Radiology.2022; 33(6): 4292. CrossRef
Diagnostic Accuracy of Computed Tomography in Predicting Primary Aldosteronism Subtype According to Age (Endocrinol Metab 2021;36:401-12, Seung Hun Lee et al.)
Seung Hun Lee, Jong Woo Kim, Hyun-Ki Yoon, Jung-Min Koh, Chan Soo Shin, Sang Wan Kim, Jung Hee Kim
Endocrinology and Metabolism.2021; 36(4): 914. CrossRef
Diagnostic Accuracy of Computed Tomography in Predicting Primary Aldosteronism Subtype According to Age (Endocrinol Metab 2021;36:401-12, Seung Hun Lee et al.)
Pankaj Singhania
Endocrinology and Metabolism.2021; 36(4): 912. CrossRef

Clinical Study
Romosozumab in Postmenopausal Korean Women with Osteoporosis: A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study: Ki-Hyun Baek, Yoon-Sok Chung, Jung-Min Koh, In Joo Kim, Kyoung Min Kim, Yong-Ki Min, Ki Deok Park, Rajani Dinavahi, Judy Maddox, Wenjing Yang, Sooa Kim, Sang Jin Lee, Hyungjin Cho, Sung-Kil Lim; Endocrinol Metab. 2021;36(1):60-69. Published online February 24, 2021; DOI: https://doi.org/10.3803/EnM.2020.848

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Background
This phase 3 study evaluated the efficacy and safety of 6-month treatment with romosozumab in Korean postmenopausal women with osteoporosis.
Methods
Sixty-seven postmenopausal women with osteoporosis (bone mineral density [BMD] T-scores ≤–2.5 at the lumbar spine, total hip, or femoral neck) were randomized (1:1) to receive monthly subcutaneous injections of romosozumab (210 mg; n=34) or placebo (n=33) for 6 months.
Results
At month 6, the difference in the least square (LS) mean percent change from baseline in lumbar spine BMD (primary efficacy endpoint) between the romosozumab (9.5%) and placebo (–0.1%) groups was significant (9.6%; 95% confidence interval, 7.6 to 11.5; P<0.001). The difference in the LS mean percent change from baseline was also significant for total hip and femoral neck BMD (secondary efficacy endpoints). After treatment with romosozumab, the percent change from baseline in procollagen type 1 N-terminal propeptide transiently increased at months 1 and 3, while that in C-terminal telopeptide of type 1 collagen showed a sustained decrease. No events of cancer, hypocalcemia, injection site reaction, positively adjudicated atypical femoral fracture or osteonecrosis of the jaw, or positively adjudicated serious cardiovascular adverse events were observed. At month 9, 17.6% and 2.9% of patients in the romosozumab group developed binding and neutralizing antibodies, respectively.
Conclusion
Treatment with romosozumab for 6 months was well tolerated and significantly increased lumbar spine, total hip, and femoral neck BMD compared with placebo in Korean postmenopausal women with osteoporosis (ClinicalTrials.gov identifier NCT02791516).

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Zepeng Chen, Ming Li, Shuzhen Li, Yuxi Li, Junyan Wu, Kaifeng Qiu, Xiaoxia Yu, Lin Huang, Guanghui Chen
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Evaluation of the efficacy and safety of romosozumab (evenity) for the treatment of osteoporotic vertebral compression fracture in postmenopausal women: A systematic review and meta‐analysis of randomized controlled trials (CDM‐J)
Wenbo Huang, Masashi Nagao, Naohiro Yonemoto, Sen Guo, Takeshi Tanigawa, Yuji Nishizaki
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Efficacy and Cardiovascular Safety of Romosozumab: A Meta-analysis and Systematic Review
Seo-Yong Choi, Jeong-Min Kim, Sang-Hyeon Oh, Seunghyun Cheon, Jee-Eun Chung
Korean Journal of Clinical Pharmacy.2023; 33(2): 128. CrossRef
Clinical Studies On Romosozumab: An Alternative For Individuals With A High Risk Of Osteoporotic Fractures: A Current Concepts Review (Part I)
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SurgiColl.2023;[Epub] CrossRef
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Dong Wu, Lei Li, Zhun Wen, Guangbin Wang
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Yun Sun Lee, So Jeong Park, Jin Young Lee, Eunah Choi, Beom-Jun Kim
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What is the risk of cardiovascular events in osteoporotic patients treated with romosozumab?
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Review Article

Bone Metabolism
Potential Biomarkers to Improve the Prediction of Osteoporotic Fractures: Beom-Jun Kim, Seung Hun Lee, Jung-Min Koh; Endocrinol Metab. 2020;35(1):55-63. Published online March 19, 2020; DOI: https://doi.org/10.3803/EnM.2020.35.1.55

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Osteoporotic fracture (OF) is associated with high disability and morbidity rates. The burden of OF may be reduced by early identification of subjects who are vulnerable to fracture. Although the current fracture risk assessment model includes clinical risk factors (CRFs) and bone mineral density (BMD), its overall ability to identify individuals at high risk for fracture remains suboptimal. Efforts have therefore been made to identify potential biomarkers that can predict the risk of OF, independent of or combined with CRFs and BMD. This review highlights the emerging biomarkers of bone metabolism, including sphongosine-1-phosphate, leucine-rich repeat-containing 17, macrophage migration inhibitory factor, sclerostin, receptor activator of nuclear factor-κB ligand, and periostin, and the importance of biomarker risk score, generated by combining these markers, in enhancing the accuracy of fracture prediction.

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Alexandra Struppe, Jakob E. Schanda, Andreas Baierl, Paul Watzl, Christian Muschitz
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Namgok Lecture 2017

Adrenal gland
Bone Health in Adrenal Disorders: Beom-Jun Kim, Seung Hun Lee, Jung-Min Koh; Endocrinol Metab. 2018;33(1):1-8. Published online March 21, 2018; DOI: https://doi.org/10.3803/EnM.2018.33.1.1

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Abstract PDF PubReader ePub

Secondary osteoporosis resulting from specific clinical disorders may be potentially reversible, and thus continuous efforts to find and adequately treat the secondary causes of skeletal fragility are critical to ameliorate fracture risk and to avoid unnecessary treatment with anti-osteoporotic drugs. Among the hyperfunctional adrenal masses, Cushing's syndrome, pheochromocytoma, and primary aldosteronism are receiving particularly great attention due to their high morbidity and mortality mainly by increasing cardiovascular risk. Interestingly, there is accumulating experimental and clinical evidence that adrenal hormones may have direct detrimental effects on bone metabolism as well. Thus, the present review discusses the possibility of adrenal disorders, especially focusing on pheochromocytoma and primary aldosteronism, as secondary causes of osteoporosis.

Citations

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Change of Computed Tomography-Based Body Composition after Adrenalectomy in Patients with Pheochromocytoma
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Special Article

Clinical Guidelines for the Management of Adrenal Incidentaloma: Jung-Min Lee, Mee Kyoung Kim, Seung-Hyun Ko, Jung-Min Koh, Bo-Yeon Kim, Sang Wan Kim, Soo-Kyung Kim, Hae Jin Kim, Ohk-Hyun Ryu, Juri Park, Jung Soo Lim, Seong Yeon Kim, Young Kee Shong, Soon Jib Yoo; Endocrinol Metab. 2017;32(2):200-218. Published online June 23, 2017; DOI: https://doi.org/10.3803/EnM.2017.32.2.200

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Abstract PDF PubReader

An adrenal incidentaloma is an adrenal mass found in an imaging study performed for other reasons unrelated to adrenal disease and often accompanied by obesity, diabetes, or hypertension. The prevalence and incidence of adrenal incidentaloma increase with age and are also expected to rise due to the rapid development of imaging technology and frequent imaging studies. The Korean Endocrine Society is promoting an appropriate practice guideline to meet the rising incidence of adrenal incidentaloma, in cooperation with the Korean Adrenal Gland and Endocrine Hypertension Study Group. In this paper, we discuss important core issues in managing the patients with adrenal incidentaloma. After evaluating core proposition, we propose the most critical 20 recommendations from the initially organized 47 recommendations by Delphi technique.

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Original Articles

Clinical Study
The Association of Higher Plasma Macrophage Migration Inhibitory Factor Levels with Lower Bone Mineral Density and Higher Bone Turnover Rate in Postmenopausal Women: Hyeonmok Kim, Seong Hee Ahn, Chaeho Shin, Seung Hun Lee, Beom-Jun Kim, Jung-Min Koh; Endocrinol Metab. 2016;31(3):454-461. Published online July 26, 2016; DOI: https://doi.org/10.3803/EnM.2016.31.3.454

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Background

Despite evidence from animal and clinical studies showing the detrimental effects of macrophage migration inhibitory factor (MIF) on bone metabolism, there are no clinical studies relating circulating MIF levels to osteoporosis-related phenotypes. This cross-sectional study investigated the association of plasma MIF with bone mineral density (BMD), bone turnover markers (BTMs), and prevalence of osteoporosis in postmenopausal Korean women.

Methods

A total of 246 women not taking any medications or diagnosed with any diseases that could affect bone metabolism were enrolled. BMD values at the lumbar spine, femoral neck, and total femur, and blood levels of MIF and BTMs were measured in all subjects. Osteoporosis was defined by World Health Organization criteria.

Results

Before and after adjustment for confounding variables, higher MIF levels were significantly associated with lower BMD values at all measured sites and higher levels of all BTMs. All BMD values and BTMs significantly changed in a dose-dependent fashion across increasing MIF quartile. When participants were divided into two groups according to osteoporosis status, postmenopausal women with osteoporosis demonstrated 24.2% higher plasma MIF levels than those without osteoporosis (P=0.041). The odds ratio per each standard deviation increment of MIF levels for prevalent osteoporosis was 1.32 (95% confidence interval, 1.01 to 1.73).

Conclusion

This study provides the first epidemiological evidence that higher plasma MIF may be associated with higher risk of osteoporosis resulting from lower bone mass and higher bone turnover rate, and thus it could be a potential biomarker of poor bone health outcomes in postmenopausal women.

Citations

Citations to this article as recorded by

The role of MIF in periodontitis: A potential pathogenic driver, biomarker, and therapeutic target
Tongfeng Fang, Liu Liu, Dongzhe Song, Dingming Huang
Oral Diseases.2023;[Epub] CrossRef
Variation of Bone Turnover Markers in Childhood and Adolescence
Yiduo Zhang, Jing Zhang, Xiaocui Huang, Xingnan Yu, Ye Li, Fan Yu, Wenjie Zhou, Ziqing Li
International Journal of Clinical Practice.2023; 2023: 1. CrossRef
Modulation of Dopamine Receptors on Osteoblasts as a Possible Therapeutic Strategy for Inducing Bone Formation in Arthritis
Elena Schwendich, Laura Salinas Tejedor, Gernot Schmitz, Markus Rickert, Jürgen Steinmeyer, Stefan Rehart, Styliani Tsiami, Jürgen Braun, Xenofon Baraliakos, Jörg Reinders, Elena Neumann, Ulf Müller-Ladner, Silvia Capellino
Cells.2022; 11(10): 1609. CrossRef
Macrophage migration inhibitory factor: a potential biomarker for chronic low back pain in patients with Modic changes
Elisabeth Gjefsen, Kristina Gervin, Guro Goll, Lars Christian Haugli Bråten, Monica Wigemyr, Hans Christian D Aass, Maria Dehli Vigeland, Elina Schistad, Linda Margareth Pedersen, Are Hugo Pripp, Kjersti Storheim, Kaja Kristine Selmer, John Anker Zwart
RMD Open.2021; 7(2): e001726. CrossRef
Potential Biomarkers to Improve the Prediction of Osteoporotic Fractures
Beom-Jun Kim, Seung Hun Lee, Jung-Min Koh
Endocrinology and Metabolism.2020; 35(1): 55. CrossRef
Elevated Expression of Macrophage Migration Inhibitory Factor Promotes Inflammatory Bone Resorption Induced in a Mouse Model of Periradicular Periodontitis
Mohammed Howait, Abdullah Albassam, Chiaki Yamada, Hajime Sasaki, Laila Bahammam, Mariane Maffei Azuma, Luciano Tavares Angelo Cintra, Abhay R. Satoskar, Satoru Yamada, Robert White, Toshihisa Kawai, Alexandru Movila
The Journal of Immunology.2019; 202(7): 2035. CrossRef
Preventive Effects of Low Parathyroid Hormone Levels on Hip Fracture in Patients with Vitamin D Deficiency
Seong-Eun Byun, Soonchul Lee, Ji Wan Kim, Yong-Chan Ha, Chul-Ho Kim, Cheungsoo Ha, Keun Jung Ryu, Jung-Min Koh, Hyung Kyung Kim, Jae Suk Chang
Journal of Bone Metabolism.2019; 26(2): 89. CrossRef
Articles inEndocrinology and Metabolismin 2016
Won-Young Lee
Endocrinology and Metabolism.2017; 32(1): 62. CrossRef
New Biological Markers of Bone Metabolism in Osteoporosis Treatment
Sun Wook Cho
Endocrinology and Metabolism.2016; 31(3): 400. CrossRef

Bone Metabolism
Efficacy of a Once-Monthly Pill Containing Ibandronate and Cholecalciferol on the Levels of 25-Hydroxyvitamin D and Bone Markers in Postmenopausal Women with Osteoporosis: In-Jin Cho, Ho-Yeon Chung, Sung-Woon Kim, Jae-Won Lee, Tae-Won Lee, Hye-Soon Kim, Sin-Gon Kim, Han Seok Choi, Sung-Hee Choi, Chan Soo Shin, Ki-Won Oh, Yong-Ki Min, Jung-Min Koh, Yumie Rhee, Dong-Won Byun, Yoon-Sok Chung, Jeong Hyun Park, Dong Jin Chung, Minho Shong, Eun-Gyoung Hong, Chang Beom Lee, Ki Hyun Baek, Moo-Il Kang; Endocrinol Metab. 2015;30(3):272-279. Published online December 9, 2014; DOI: https://doi.org/10.3803/EnM.2015.30.3.272

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Background

The present study evaluated the efficacy of a combination of ibandronate and cholecalciferol on the restoration of the levels of 25-hydroxyvitamin D (25[OH]D) and various bone markers in postmenopausal women with osteoporosis.

Methods

This was a randomized, double-blind, active-controlled, prospective 16-week clinical trial conducted in 20 different hospitals. A total of 201 postmenopausal women with osteoporosis were assigned randomly to one of two groups: the IBN group, which received a once-monthly pill containing 150 mg ibandronate (n=99), or the IBN+ group, which received a once-monthly pill containing 150 mg ibandronate and 24,000 IU cholecalciferol (n=102). Serum levels of 25(OH)D, parathyroid hormone (PTH), and various bone markers were assessed at baseline and at the end of a 16-week treatment period.

Results

After 16 weeks of treatment, the mean serum levels of 25(OH)D significantly increased from 21.0 to 25.3 ng/mL in the IBN+ group but significantly decreased from 20.6 to 17.4 ng/mL in the IBN group. Additionally, both groups exhibited significant increases in mean serum levels of PTH but significant decreases in serum levels of bone-specific alkaline phosphatase and C-telopeptide of type 1 collagen (CTX) at 16 weeks; no significant differences were observed between the groups. However, in subjects with a vitamin D deficiency, IBN+ treatment resulted in a significant decrease in serum CTX levels compared with IBN treatment.

Conclusion

The present findings demonstrate that a once-monthly pill containing ibandronate and cholecalciferol may be useful for the amelioration of vitamin D deficiency in patients with postmenopausal osteoporosis. Moreover, this treatment combination effectively decreased serum levels of resorption markers, especially in subjects with a vitamin D deficiency, over the 16-week treatment period.

Citations

Citations to this article as recorded by

Effect of vitamin D supplementation or fortification on bone turnover markers in women: a systematic review and meta-analysis
Nasrin Nasimi, Sanaz Jamshidi, Aida Askari, Nazanin Zolfaghari, Erfan Sadeghi, Mehran Nouri, Nick Bellissimo, Shiva Faghih
British Journal of Nutrition.2024; 131(9): 1473. CrossRef
Quality of life and patient satisfaction with raloxifene/cholecalciferol combination therapy in postmenopausal women
Dong-Yun Lee, Yoon-Sok Chung
Scientific Reports.2022;[Epub] CrossRef
Efficacy of risedronate with cholecalciferol on bone mineral density in Korean patients with osteoporosis
So Young Park, Moo-Il Kang, Hyung Moo Park, Yumie Rhee, Seong Hwan Moon, Hyun Koo Yoon, Jung-Min Koh, Jae Suk Chang, In Joo Kim, Ye Yeon Won, Ye Soo Park, Hoon Choi, Chan Soo Shin, Taek Rim Yoon, Sung-Cheol Yun, Ho-Yeon Chung
Archives of Osteoporosis.2020;[Epub] CrossRef
Efficacy and safety of vitamin D3 B.O.N intramuscular injection in Korean adults with vitamin D deficiency
Han Seok Choi, Yoon-Sok Chung, Yong Jun Choi, Da Hea Seo, Sung-Kil Lim
Osteoporosis and Sarcopenia.2016; 2(4): 228. CrossRef
Pharmacologic treatment of osteoporosis
Yong-Ki Min
Journal of the Korean Medical Association.2016; 59(11): 847. CrossRef

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