Study on the microRNA Expression Level in Postmenopausal Osteoporosis

Postmenopausal Osteoporosis Clinical Trial

— microRNA  

Official title:

Study on the Molecular Mechanism in Postmenopausal Osteoporosis With Kidney Yin Deficiency Syndrome Based on miRNA Mediated Gene Translation Regulation Function by Targeting CLCF1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128009
• Other study ID #: 2013-2-73
• Status: Completed
• Start date: February 2014
• Est. completion date: January 2017

Study information

• Verified date: February 2019
• Source: Fujian Academy of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The miRNA plays an important regulation role in gene expression, and also closely related to bone metabolism. Previous research found that postmenopausal osteoporosis with kidney Yin deficiency syndrome (POP) is associated with CLCF1 gene. This project proposed by bioinformatics prediction CLCF1 targeted regulation of miRNAs, and use the 3 'UTR dual luciferase report system for target validation, aimed at the miRNA levels to explore postmenopausal osteoporosis molecular mechanism with kidney Yin deficiency syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• The Participants who volunteer to be test subjects, and can accept experimental drugs, and promise to finish the course should sign the informed consent.

• Female ages 45 to 75 had gone through natural menopause before two years

• In accordance with the western medicine diagnostic criteria of osteoporosis and belong to kidney Yin deficiency syndrome differentiation of traditional Chinese medicine certificate;

• In accordance with the western medicine diagnostic criteria;

• In accordance with TCM diagnostic methods; .If any of the above answers are no, The subjects couldn't in the study.

Exclusion Criteria:

• Do not accord with standard of the western medicine diagnosis and TCM diagnostic methods

• Age: <44 and > 76 years old;

• With hyperparathyroidism, osteomalacia, rheumatoid arthritis, multiple myeloma and other serious complications such as secondary osteoporosis; Late or deformity, disability, loss of labor;

• With cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases;

• Psychosis or alzheimer's patients;

• Nearly three months, the use of hormone replacement therapy (HRT) and taking calcitonin, nearly six months has used double phosphonic acid salt for 15 days, etc.;

• This medicine allergic constitution or composition of known to have allergies;

• In a critical condition, It's difficult to make exact evaluators to efficacy and safety of the new drugs;

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Other:
• osteoporosis

Locations

Country	Name	City	State
China	Fujian Institute of Trational Chiness Medicine	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Academy of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

McClung MR, Grauer A, Boonen S, Bolognese MA, Brown JP, Diez-Perez A, Langdahl BL, Reginster JY, Zanchetta JR, Wasserman SM, Katz L, Maddox J, Yang YC, Libanati C, Bone HG. Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med. 2014 Jan 30;370(5):412-20. doi: 10.1056/NEJMoa1305224. Epub 2014 Jan 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microRNA expression lever in the Peripheral Blood		one year