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Trial record 4 of 160 for:    Recruiting, Not yet recruiting, Available Studies | "Osteoporosis"

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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2016 by Taipei Medical University WanFang Hospital
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT02705040
First received: January 29, 2016
Last updated: March 6, 2016
Last verified: January 2016
  Purpose
This study is aimed to evaluate the roles of specific miRNAs in osteoporosis in men.

Condition Intervention
Osteoporosis Other: Normal Other: Osteopenia Other: Osteoporosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Roles of microRNAs in the Development of Osteoporosis in Men - Preliminary Study

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • Bone mineral density [ Time Frame: 30 minutes ]
    T scale


Biospecimen Retention:   Samples Without DNA
Plasma, urine

Estimated Enrollment: 30
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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: Normal
bone mineral density T>=-1.0
Other: Osteoporosis
bone mineral density T<-2.5
Osteoporosis
bone mineral density T<-2.5
Other: Normal
bone mineral density T>=-1.0
Other: Osteopenia
bone mineral density -1.0>T>=-2.5

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.
  Eligibility

Ages Eligible for Study:   70 Years to 90 Years   (Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The oriental men
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02705040

Contacts
Contact: Ruei-Ming Chen, PhD +886-27361661 ext 3222 rmchen@tmu.edu.tw

Locations
Taiwan
Taipei Medical University Wanfang Hospital Recruiting
Taipei, Taiwan
Contact: Ruei-Ming Chen, PhD    +886-27361661 ext 3222    rmchen@tmu.edu.tw   
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Ruei-Ming Chen, PhD Taipei Medical University
  More Information

Responsible Party: Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT02705040     History of Changes
Other Study ID Numbers: TMU-JIRB 201310015
Study First Received: January 29, 2016
Last Updated: March 6, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Taipei Medical University WanFang Hospital:
male osteoporosis
miRNA
biomarker

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

ClinicalTrials.gov processed this record on August 18, 2017