OsteoporosisNCT02162277
Therapeutic Strategy in Postmenopausal Women Using Osteoporotic Diagnostic Kits
An observational study of Osteoporosis, run by Shinshu University at 1 site in Japan.
Trial summary
The frequency of osteoporosis in Japan is increasing. Also, the frequency of osteoporosis-based fractures in postmenopausal women is increasing. Therefore, it is urgently required to improve osteoporosis. Read more about this study
- Who is it for?
- Ages 20 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- diagnostic osteoporotic kit ( including 7 genes and 4 life styles)
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2013to Sep 2018
- 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 20 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who are over 20 years old
Who may be able to join
- Women, mainly postmenopausal women
Who cannot join
- Men
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Osteoporotic Diagnosis Using Osteoporotic Diagnostic Kits
The frequency of osteoporosis in Japan is increasing. Also, the frequency of osteoporosis-based fractures in postmenopausal women is increasing. Therefore, it is urgently required to improve osteoporosis. Life expectancy in Nagano prefecture is the longest in Japan, however, healthy life expectancy in Nagano is not very long in Japan. There are several problems in this issue from the medical site and the patient site. The aim of this study is, from the patient site, to increase the motivation of postmenopausal women for osteoporosis using osteoporotic diagnostic kit.
- Conditions
- Osteoporosis
- Being tested
- diagnostic osteoporotic kit ( including 7 genes and 4 life styles)
- Keywords
- To decrease, number, osteoporotic, patients in, Kami-Ina area, Nagano prefecture
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic osteoporotic kit ( including 7 genes and 4 life styles)Device
Most osteoporotic patients want to know what kinds of life styles they should take care of. The device will help it.
| Study group | Role | What they receive |
|---|---|---|
| Osteoporosis diagnostic kit | Not described Receives: Device: diagnostic osteoporotic kit ( including 7 genes and 4 life styles) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with osteoporosis in Kami-Ina area of Nagano prefecture
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startJan 2013
- Primary completionOct 2016
- Study completionSep 2018
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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shinshu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yukio Nakamura, Shinshu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162277
- Sponsor's protocol ID
- Showa-Hitachi2014
- Other IDs
- Osteoporotic diagnostic kit
- Status last verified
- Sep 2018
- First submitted
- 9 Jun 2014
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Osteoporotic Diagnosis Using Osteoporotic Diagnostic Kits
- ClinicalTrials.gov ID
- NCT02162277
- Acronym / sponsor ID
- Showa-Hitachi2014
- Conditions
- Osteoporosis
- Keywords
- To decrease, number, osteoporotic, patients in, Kami-Ina area, Nagano prefecture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shinshu UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 12 Jun 2014 (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.
The frequency of osteoporosis in Japan is increasing. Also, the frequency of osteoporosis-based fractures in postmenopausal women is increasing. Therefore, it is urgently required to improve osteoporosis. Life expectancy in Nagano prefecture is the longest in Japan, however, healthy life expectancy in Nagano is not very long in Japan. There are several problems in this issue from the medical site and the patient site. The aim of this study is, from the patient site, to increase the motivation of postmenopausal women for osteoporosis using osteoporotic diagnostic kit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteoporosis diagnostic kit | – | Device: diagnostic osteoporotic kit ( including 7 genes and 4 life styles) |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who are over 20 years old
Key inclusion criteria (1 listed)
- Women, mainly postmenopausal women
Key exclusion criteria (1 listed)
- Men
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 |
|---|---|---|
| diagnostic osteoporotic kit ( including 7 genes and 4 life styles)Most osteoporotic patients want to know what kinds of life styles they should take care of. The device will help it. | Device | Osteoporosis diagnostic kit |
Primary outcome
Number of participants with osteoporosis in Kami-Ina area of Nagano prefecture
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Shinshu University at 1 site in Japan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Sep 2018. 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 Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with osteoporosis in Kami-Ina area of Nagano prefecture (time frame: 1 year). 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 6 Sep 2018.