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RESEARCH ARTICLE
Year : 2018  |  Volume : 3  |  Issue : 3  |  Page : 66-73

Calcitonin plus calcium for viral cirrhosis with osteoporosis: a randomized, parallel, controlled clinical trial


1 Department of Pharmacy, Yantai Affiliated Hospital, Binzhou Medical University, Yantai, Shandong Province, China
2 State-owned Assets Division, Yantai Affiliated Hospital, Binzhou Medical University, Yantai, Shandong Province, China
3 Department of Osteoarthritis and Sports Medicine, Yantai Affiliated Hospital, Binzhou Medical University, Yantai, Shandong Province, China
4 Emergency Department, Yantai Affiliated Hospital, Binzhou Medical University, Yantai, Shandong Province, China

Correspondence Address:
Ai-Qun Li
Emergency Department, Yantai Affiliated Hospital, Binzhou Medical University, Yantai, Shandong Province
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2542-4157.240469

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Background and objectives: In patients with osteoporosis and cirrhosis, the relative deficiency of vitamin D may result in osteomalacia and endocrine disorders. Few studies have investigated drug treatment for chronic liver disease combined with osteoporosis. This study will determine the efficacy and safety of salmon calcitonin combined with calcium in the treatment of viral cirrhosis with osteoporosis. Methods: This prospective, single-center, open-label, randomized, parallel, controlled, 2-year follow-up clinical trial includes 102 outpatients and hospitalized patients with viral cirrhosis plus osteoporosis in Yantai Affiliated Hospital, Binzhou Medical University, China. The 102 patients are equally and randomly divided into two groups. The control group receives oral calcium, while the combination group will receive intramuscular salmon calcitonin plus oral calcium; both groups receives treatment for 24 months. This trial was approved by the Ethics Committee, Yantai Affiliated Hospital, Binzhou Medical University in July 2018 (approval No. 2018071601). The study protocol has been conducted in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent is obtained from all participants. Results: The primary outcome measure is bone mineral density at L2–4 at 24 months after treatment commences. Secondary outcome measures include bone mineral density at L2–4 before treatment, and at 6 and 12 months after treatment commences; bone mineral density of the femoral neck and Ward’s triangle at 6, 12, and 24 months after treatment commences; serum calcium, phosphorus, 1,25(OH)2D3, parathyroid hormone, osteocalcin, interleukin-10, interleukin-6, tumor necrosis factor-alpha, and insulin-like growth factor 1 levels before treatment, and at 6, 12 and 24 months after treatment commences; adverse reaction rate at 6, 12, and 24 months after treatment commences. Our team obtained preliminary results from 2012 to 2016 for 64 patients. The 12-month follow-up results found that compared with the control group (n = 32), the combination group (n = 32) had significantly increased levels of serum calcium, 1,25(OH)2D3, interleukin-10, and insulin-like growth factor 1, and significantly increased bone mineral density at L2–4, femoral neck, and Ward’s triangle, but significantly reduced levels of serum phosphorus, parathyroid hormone, osteocalcin, interleukin-6, and tumor necrosis factor-alpha (all P < 0.05). Conclusion: The results verify that salmon calcitonin combined with calcium is suitable for the treatment of viral cirrhosis with osteoporosis. Trial registration: This trial was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR1800017732) on August 11, 2018. Protocol version (1.0).


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