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

NCT02705040 | Unknown

• 1 other identifier: TMU-JIRB 201310015
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aimed to evaluate the roles of specific miRNAs in osteoporosis in men.

Conditions

Osteoporosis

Keywords

male osteoporosis; miRNA; biomarker

Outcome Measures

Primary Outcomes (1)

• Bone mineral density

  T scale

  30 minutes

Study Arms (3)

Normal

bone mineral density T\>=-1.0

Other: Osteopenia; Other: Osteoporosis

Osteopenia

bone mineral density -1.0\>T\>=-2.5

Other: Normal; Other: Osteoporosis

Osteoporosis

bone mineral density T\<-2.5

Other: Normal; Other: Osteopenia

Interventions

Normal OTHER

bone mineral density T\>=-1.0

Osteopenia; Osteoporosis

Osteopenia OTHER

bone mineral density -1.0\>T\>=-2.5

Normal; Osteoporosis

Osteoporosis OTHER

bone mineral density T\<-2.5

Normal; Osteopenia

Eligibility Criteria

• Age: 70 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The oriental men

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Taipei Medical University Wanfang Hospital

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, urine

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ruei-Ming Chen, PhD

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruei-Ming Chen, PhD

CONTACT

+886-27361661; rmchen@tmu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: March 10, 2016
• Study Start: December 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 10, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)