Endocrinology and Metabolism

Original Article

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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Abstract PDF Supplementary Material PubReader ePub

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).

Citations

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A pharmacovigilance analysis of FDA adverse event reporting system events for romosozumab
Zepeng Chen, Ming Li, Shuzhen Li, Yuxi Li, Junyan Wu, Kaifeng Qiu, Xiaoxia Yu, Lin Huang, Guanghui Chen
Expert Opinion on Drug Safety.2023; 22(4): 339. CrossRef
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
Pharmacoepidemiology and Drug Safety.2023; 32(6): 671. CrossRef
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)
E. Carlos Rodriguez-Merchan, Alonso Moreno-Garcia, Hortensia De la Corte-Rodriguez
SurgiColl.2023;[Epub] CrossRef
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Frideriki Poutoglidou, Efthimios Samoladas, Nikolaos Raikos, Dimitrios Kouvelas
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The Korean Journal of Internal Medicine.2022; 37(4): 821. CrossRef
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Case Reports

Thyroid
Hyponatremia after Thyroid Hormone Withdrawal in a Patient with Papillary Thyroid Carcinoma: Hyo Jin Jo, Yong Hyun Kim, Dong Hyun Shin, Mi Jeoung Kim, Sang Jin Lee, Dong Ok Jeon, Sung Gyu Im, Sun Kyung Jang, Jin Young Choi; Endocrinol Metab. 2014;29(1):77-82. Published online March 14, 2014; DOI: https://doi.org/10.3803/EnM.2014.29.1.77

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Hyponatremia is an electrolyte abnormality commonly found in clinical practice. It is important to diagnose the underlying etiology of the hyponatremia and correct it appropriately because severe hyponatremia can cause serious complications and substantially increase the risk of mortality. Although hypothyroidism is known to be a cause of hyponatremia, it is rare that hyponatremia occurs in relation to hypothyroidism induced by thyroid hormone withdrawal in patients with differentiated thyroid cancer. We report a case of a 76-year-old woman with papillary thyroid carcinoma presenting with severe hyponatremia related to hypothyroidism induced by thyroid hormone withdrawal for radio-active iodine whole-body scanning, who was treated by thyroid hormone replacement and hydration. Considering that the incidence of differentiated thyroid cancer is rapidly increasing, physicians should be aware that, although uncommon, hyponatremia can occur in patients undergoing radioiodine therapy or diagnostic testing.

Citations

Citations to this article as recorded by

Effect of preparation method for radioactive iodine therapy on serum electrolytes
Noriko Takata, Masao Miyagawa, Tomohisa Okada, Naoto Kawaguchi, Yutaka Fujimoto, Yoshihiro Kouchi, Shintaro Tsuruoka, Kotaro Uwatsu, Teruhito Kido
Japanese Journal of Radiology.2023; 41(11): 1247. CrossRef
MANAGEMENT OF ENDOCRINE DISEASE: Hypothyroidism-associated hyponatremia: mechanisms, implications and treatment
G Liamis, T D Filippatos, A Liontos, M S Elisaf
European Journal of Endocrinology.2017; 176(1): R15. CrossRef
Articles in 'Endocrinology and Metabolism' in 2014
Won-Young Lee
Endocrinology and Metabolism.2015; 30(1): 47. CrossRef
Parathyroid hormone-related protein serves as a prognostic indicator in oral squamous cell carcinoma
Zhongjing Lv, Xiangbing Wu, Wei Cao, ZongZe Shen, Lizhen Wang, FuRong Xie, JianJun Zhang, Tong Ji, Ming Yan, WanTao Chen
Journal of Experimental & Clinical Cancer Research.2014;[Epub] CrossRef
Hyponatremia and the Thyroid: Causality or Association?
Kevin Pantalone, Betul Hatipoglu
Journal of Clinical Medicine.2014; 4(1): 32. CrossRef

A Case of Thyroid Microcarcinoma with Multiple Metastases, Including Liver Metastasis.: Sang Jin Lee, Won Gu Kim, Hyung Yong Kim, Hyun Gi Lee, Tae Yong Kim, Youn Suck Koh; J Korean Endocr Soc. 2007;22(1):50-54. Published online February 1, 2007; DOI: https://doi.org/10.3803/jkes.2007.22.1.50

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Abstract PDF: A 65-year-old woman presented with a dry cough and multiple various sized nodules in both lungs on chest X-ray. A CT scan showed a 9.5 cm sized hypervascular mass in the liver and a 5.5 cm sized intraabdominal mass. A percutaneous needle biopsy of one of the lung nodules revealed a metastatic follicular thyroid carcinoma. Therefore, thyroid ultrasonography was performed, which revealed a 1 cm sized nodule in the right thyroid lobe. Cytology, obtained by ultrasonography guided fine needle aspiration, revealed a follicular neoplasm. The tumor cells were weakly positive on galectin-3 immunostaining, which favored a follicular carcinoma. An ultrasonography guided biopsy of the liver and EUS (endoscopic ultrasonography)-guided biopsy of the intraabdominal mass revealed a metastatic follicular thyroid carcinoma in the liver and peritoneum. We report a very rare case of a follicular thyroid microcarcinoma, with multiple metastases to the lung, liver and peritoneum.

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