Roles of microRNAs in the Development of Osteoporosis in Men - Preliminary Study

March 6, 2016 updated by: Taipei Medical University WanFang Hospital
This study is aimed to evaluate the roles of specific miRNAs in osteoporosis in men.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In the past, osteoporosis is usually viewed as a woman disease. However, men and women are shown to lose their bone mass at the same rate by more than 65 of age, and osteoporosis in men causes higher mortality in men than those in women. Thus, osteoporosis in men has recently aroused public attention. Androgen deficiency was the main cause leading to osteoporosis. Bone structure is maintained by a dynamic balance of osteoblast-mediated bone formation and osteoclast-mediated bone resorption. Androgens and androgen receptor (AR) play critical roles in regulation of bone formation and resorption. MicroRNAs (miRNAs) are non-coding small RNAs and participate in regulating activities of osteoblasts and osteoclasts by postranslationally targeting certain gene expressions. miR-133 and -135 can target BMP-2, Runx2, and Smad5 and then regulate osteoblast differentiation. Likewise, miR-141 and -200a negatively regulated osteoblast differentiation. Nevertheless, the functional roles of miRNAs in osteoporosis in men are still unknown. In addition, miRNA are stable and can be detected in the blood as novel biomarkers for certain diseases. A recent study analyzed the levels of miRNAs in circulating monocytes of 10 high and 10 low bone mineral density postmenopausal Caucasian women and found miR-133a is a potential biomarker for postmenopausal osteoporosis. In comparison, the roles of blood miRNAs in osteoporosis in men have not been evaluated. Therefore, this study is aimed to evaluate the roles of specific miRNAs in osteoporosis in men.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Taipei Medical University WanFang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 90 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

The oriental men

Description

Inclusion Criteria:

  1. Twenty oriental men (mean age, 80 years; age range, 70-90 years).
  2. Candidates have no clinical evidence or history of focal lesions of the femur; previous hip surgery or irradiation; hip trauma; spinal trauma.
  3. Participants who have thoroughly understood and signed the consent form.
  4. Ten normal adult male (age range, 20-40 years).

Exclusion Criteria:

  1. Participants with secondary causes of osteoporosis, such as thyroid, parathyroid disease, osteogenesis imperfect and osteomalacia.
  2. Participants with Paget's disease, serious liver disease, serious renal disease (indicated by a serum creatinine concentration of more than 1.6mg/dL).
  3. Participants who currently or have history of using steroids or hormone replacement therapy.
  4. Participants who fail to sign to the consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal
bone mineral density T>=-1.0
Other: Osteopenia
bone mineral density -1.0>T>=-2.5
Other: Osteoporosis
bone mineral density T<-2.5
Osteopenia
bone mineral density -1.0>T>=-2.5
Other: Osteoporosis
bone mineral density T<-2.5
Other: Normal
bone mineral density T>=-1.0
Osteoporosis
bone mineral density T<-2.5
Other: Osteopenia
bone mineral density -1.0>T>=-2.5
Other: Normal
bone mineral density T>=-1.0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone mineral density
Time Frame: 30 minutes
T scale
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University WanFang Hospital

Investigators

  • Principal Investigator: Ruei-Ming Chen, PhD, Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

January 29, 2016

First Submitted That Met QC Criteria

March 6, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Estimate)

March 10, 2016

Last Update Submitted That Met QC Criteria

March 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMU-JIRB 201310015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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