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CompletedNCT02128009microRNAUpdated Feb 26, 2019

Study on the microRNA Expression Level in Postmenopausal Osteoporosis

An observational study in Postmenopausal Osteoporosis, sponsored by Fujian Academy of Traditional Chinese Medicine. Completed at 1 site in China. Open to female participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-26.

Sponsored by Fujian Academy of Traditional Chinese Medicine · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
45 Years to 75 Years
Sex
Female
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Study 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.

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Conditions studied

  • Postmenopausal Osteoporosis
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In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 60 is below the median of 174 across 446 observational studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Fujian Academy of Traditional Chinese Medicine is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

outpatient clinic

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

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;
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • osteoporosis,non-osteoporosis

    Other: osteoporosis

Interventions

  • Otherosteoporosis
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What researchers measure

Primary outcomes

  1. microRNA expression lever in the Peripheral Blood

    Time frame: one year

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Study locations

1 site
  • Fujian Institute of Trational Chiness Medicine
    Fuzhou, Fujian 350003, China
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References and documents

Publications

  • 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. PubMed 24382002 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02128009
Lead sponsor
Fujian Academy of Traditional Chinese Medicine
Responsible party
Sponsor
First posted
May 1, 2014
Start date
Feb 2014
Primary completion
Dec 2016
Completion
Jan 2017
Last update
Feb 26, 2019

Study contacts

FJ ITCM, provincial
principal investigator · Fujian Institute of Trational Chiness Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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