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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02128009
Other study ID # 2013-2-73
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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;

Study Design


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
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