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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02705040
• Other study ID #: TMU-JIRB 201310015
• Status: Recruiting
• Phase: N/A
• First received: January 29, 2016
• Last updated: March 6, 2016
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2016
• Source: Taipei Medical University WanFang Hospital
• Contact: Ruei-Ming Chen, PhD
• Phone: +886-27361661
• Email: rmchen[@]tmu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 70 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• Normal
bone mineral density T>=-1.0
• Osteopenia
bone mineral density -1.0>T>=-2.5
• Osteoporosis
bone mineral density T<-2.5

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Wanfang Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density	T scale	30 minutes	No