Efficacy and safety of salmon calcitonin combined with calcium for viral cirrhosis with osteoporosis: study protocol for a randomized, parallel, controlled, 2-year follow-up clinical trial and preliminary results

doi:10.3969/j.issn.2095-4344.0544

Abstract

Abstract:

BACKGROUND: Chronic liver disease is one of risk factors for osteoporosis. At present, there are few studies on drug treatment for chronic liver disease combined with osteoporosis. For patients with osteoporosis, oral calcium therapy is often required, but the efficacy with calcium alone is not good. In patients with osteoporosis and cirrhosis, the relative deficiency of vitamin D in the body may result in osteomalacia and endocrine disorders. As an important calcium- and phosphorus-regulating hormone, calcitonin can diminish blood calcium and blood phosphorus, and further promote osteogenic differentiation.
OBJECTIVE: To investigate the efficacy and safety of salmon calcitonin combined with calcium in the treatment of viral cirrhosis with osteoporosis.
METHODS: This is a prospective, single-center, open-label, randomized, parallel, controlled, 2-year follow-up clinical trial. This study will include 102 outpatients and hospitalized patients with viral cirrhosis combined with osteoporosis in Yantai Affiliated Hospital of Binzhou Medical University, China. The 102 patients will be equally and randomly divided into two groups. The patients in the control group will receive oral calcium treatment, and the patients in the combination group will receive intramuscular injection of salmon calcitonin combined with oral calcium treatment, for 24 months. The primary outcome measure will be bone mineral density at the L2-4 at 24 months after treatment. The secondary outcome measures will include bone mineral density at the L2-4 before treatment, at 6 and 12 months after treatment; bone mineral density of the femoral neck and Ward's triangle at 6, 12 and 24 months after treatment; 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, at 6, 12 and 24 months after treatment; adverse reaction rate at 6, 12 and 24 months after treatment. This study protocol was approved by Medical Ethics Committee by Yantai Affiliated Hospital of Binzhou Medical University in July 2018 (2018071601). This study will be performed in strict accordance with the Declaration of Helsinki developed by the World Medical Association. Written informed consent will be obtained from each patient. This study was designed in March 2018. Patient recruitment and data collection will begin in October 2018. Participant recruitment will end in October 2019. Data analysis will be performed in January 2022. The whole study will be completed in February 2022. Dissemination plans include presentations at scientific conferences and peer-reviewed scientific publications. This study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800017732). Protocol version: 1.0.
RESULTS AND CONCLUSION: Our team has published preliminary results for 64 patients. The 12-month follow-up results demonstrated that compared with the control group (n=32; oral calcium), serum calcium, 1,25(OH)2D3, interleukin-10, insulin-like growth factor 1 levels, and bone mineral density of L2-4, femoral neck and Ward's triangle were significantly increased, but serum phosphorus, parathyroid hormone and osteocalcin, interleukin-6, tumor necrosis factor alpha levels were significantly reduced in the treatment group (n=32; intramuscular injection of salmon calcitonin combined with oral calcium) (both P < 0.05). The trial will verify that salmon calcitonin combined with calcium is a suitable method for the treatment of viral cirrhosis with osteoporosis. Clinical data will confirm that their combination can remarkably improve bone mineral density of the lumbar spine and hip, improve bone biochemical indicators, and reduce the incidence of adverse reactions, with good long-term efficacy.

中国组织工程研究杂志出版内容重点：组织构建；骨细胞；软骨细胞；细胞培养；成纤维细胞；血管内皮细胞；骨质疏松；组织工程

Key words: Tissue Engineering, Osteoporosis, Liver Cirrhosis, Calcitonin, Bone Density

CLC Number:

R318

Wang Jing-feng1, Liu Tao2, Zhou Bai-sui3, Li Ai-qun4. Efficacy and safety of salmon calcitonin combined with calcium for viral cirrhosis with osteoporosis: study protocol for a randomized, parallel, controlled, 2-year follow-up clinical trial and preliminary results[J]. Chinese Journal of Tissue Engineering Research, 2018, 22(32): 5091-5096.

Figures/Tables 1

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