Postmenopausal OsteoporosismicroRNANCT02128009
Study on the microRNA Expression Level in Postmenopausal Osteoporosis
An observational study of Postmenopausal Osteoporosis, run by Fujian Academy of Traditional Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- osteoporosis
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Jan 2017
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: outpatient clinic
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
Fujian Institute of Trational Chiness Medicine
Fuzhou, Fujian, 350003
About this study
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
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
- Being tested
- osteoporosis
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteoporosisOther
| Study group | Role | What they receive |
|---|---|---|
| osteoporosis,non-osteoporosis | Not described Receives: Other: osteoporosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
microRNA expression lever in the Peripheral Blood
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fujian Academy of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FJ ITCM, provincial, Principal investigator, Fujian Institute of Trational Chiness Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128009
- Sponsor's protocol ID
- 2013-2-73
- Acronym
- microRNA
- Status last verified
- Feb 2019
- First submitted
- 14 Mar 2014
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02128009
- Acronym / sponsor ID
- microRNA / 2013-2-73
- Conditions
- Postmenopausal Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fujian Academy of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| osteoporosis,non-osteoporosis | – | Other: osteoporosis |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- outpatient clinic
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| osteoporosis | Other | osteoporosis,non-osteoporosis |
Primary outcome
microRNA expression lever in the Peripheral Blood
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Background: PubMed 24382002McClung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FJ ITCM, provincial principal investigator
Fujian Institute of Trational Chiness Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Osteoporosis, run by Fujian Academy of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microRNA expression lever in the Peripheral Blood (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02128009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.