Study on the microRNA Expression Level in Postmenopausal Osteoporosis

NCT02128009 | Completed DMC

• 1 other identifier: 2013-2-73
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

• microRNA expression lever in the Peripheral Blood

  one year

Study Arms (1)

osteoporosis,non-osteoporosis

Other: osteoporosis

Interventions

osteoporosis OTHER

osteoporosis,non-osteoporosis

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

outpatient clinic

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fujian Academy of Traditional Chinese Medicine: lead

Study Sites (1)

Fujian Institute of Trational Chiness Medicine

Fuzhou, Fujian, 350003, China

Location

Related 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.

  PMID: 24382002 BACKGROUND

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• FJ ITCM, provincial

  Fujian Institute of Trational Chiness Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: May 1, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

CN (1)