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Study on the microRNA Expression Level in Postmenopausal Osteoporosis (microRNA)

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ClinicalTrials.gov Identifier: NCT02128009
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Fujian Academy of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment
Postmenopausal Osteoporosis Other: osteoporosis

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Study Type : Observational [Patient Registry]
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
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
Study Start Date : February 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Group/Cohort Intervention/treatment
osteoporosis,non-osteoporosis Other: osteoporosis



Primary Outcome Measures :
  1. microRNA expression lever in the Peripheral Blood [ Time Frame: one year ]


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
outpatient clinic
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128009


Locations
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China, Fujian
Fujian Institute of Trational Chiness Medicine
Fuzhou, Fujian, China, 350003
Sponsors and Collaborators
Fujian Academy of Traditional Chinese Medicine
Investigators
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Principal Investigator: FJ ITCM, provincial Fujian Institute of Trational Chiness Medicine

Additional Information:

Publications:
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Responsible Party: Fujian Academy of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02128009     History of Changes
Other Study ID Numbers: 2013-2-73
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases