OsteoporosisNCT02705040
Roles of microRNAs in the Development of Osteoporosis in Men - Preliminary Study
An observational study of Osteoporosis, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
This study is aimed to evaluate the roles of specific miRNAs in osteoporosis in men. Read more about this study
- Who is it for?
- Ages 70 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Normal, Osteopenia and Osteoporosis
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2013to Dec 2016
- 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 70 to 90 years
- Men only
- Healthy volunteers accepted
- Older adult
Study population: The oriental men
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Wanfang Hospital
Taipei
Ruei-Ming Chen, PhD, +886-27361661 ext. 3222, rmchen@tmu.edu.tw
About this study
This study is aimed to evaluate the roles of specific miRNAs in osteoporosis in men.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Normal, Osteopenia, Osteoporosis
- Keywords
- male osteoporosis, miRNA, biomarker
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NormalOther
bone mineral density T>=-1.0
OsteopeniaOther
bone mineral density -1.0>T>=-2.5
OsteoporosisOther
bone mineral density T<-2.5
| Study group | Role | What they receive |
|---|---|---|
| Normal | bone mineral density T>=-1.0 Receives: Other: Osteopenia; Other: Osteoporosis | |
| Osteopenia | bone mineral density -1.0>T>=-2.5 Receives: Other: Normal; Other: Osteoporosis | |
| Osteoporosis | bone mineral density T<-2.5 Receives: Other: Normal; Other: Osteopenia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
T scale
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startDec 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruei-Ming Chen, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705040
- Sponsor's protocol ID
- TMU-JIRB 201310015
- Status last verified
- Jan 2016
- First submitted
- 29 Jan 2016
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roles of microRNAs in the Development of Osteoporosis in Men - Preliminary Study
- ClinicalTrials.gov ID
- NCT02705040
- Acronym / sponsor ID
- TMU-JIRB 201310015
- Conditions
- Osteoporosis
- Keywords
- male osteoporosis, miRNA, biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Mar 2016 (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.
This study is aimed to evaluate the roles of specific miRNAs in osteoporosis in men.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Other: Osteopenia, Other: Osteoporosisbone mineral density T>=-1.0 |
| Osteopenia | – | Other: Normal, Other: Osteoporosisbone mineral density -1.0>T>=-2.5 |
| Osteoporosis | – | Other: Normal, Other: Osteopeniabone mineral density T<-2.5 |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The oriental men
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Normalbone mineral density T>=-1.0 | Other | Osteopenia, Osteoporosis |
| Osteopeniabone mineral density -1.0>T>=-2.5 | Other | Normal, Osteoporosis |
| Osteoporosisbone mineral density T<-2.5 | Other | Normal, Osteopenia |
Primary outcome
Bone mineral density
Time frame: 30 minutes
T scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Individual participant dataSharing planned: No
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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.
Ruei-Ming Chen, PhD principal investigator
Taipei Medical University
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 Osteoporosis, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Mar 2016. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruei-Ming Chen, PhD (+886-27361661 ext. 3222, rmchen@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2016.