Premature Ovarian InsufficiencyPOINCT06339489
The Bone Metabolism Characteristics of Premature Ovarian Insufficiency
An observational study of Premature Ovarian Insufficiency and Bone Diseases, Metabolic, run by Shi Yun at 1 site in China.
Trial summary
Explore the bone metabolism characteristics of premature ovarian insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Premature Ovarian Insufficiency, Bone Diseases, Metabolic, Bone Mineral Density
- What is being tested?
- Testing the serum levels of bone metabolic markers
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Feb 2025
- 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 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Study population: females with premature ovarian insufficiency
Who may be able to join
- Patients diagnosed by Western medicine with premature ovarian insufficiency. 18 ≤ patients' age ≤ 39 years;. Patients who voluntarily participate in this study, sign an informed consent form.
Who cannot join
- Patients with congenital gonadal dysplasia or a family history similar to "early menopause".
- POI patients with acquired organic lesions or ovarian surgery. Patients who have taken Western or herbal medicine artificial cycle therapy or other endocrine therapy in the past three months.
- Patients with serious primary diseases and mental disorders such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system.
- Patients who are breastfeeding or pregnant.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing
Xueting Han, +861084012709, dzmyyec@126.com
Yun Shi, phD
About this study
Official title: Explore the Bone Metabolism Characteristics of Premature Ovarian Insufficiency
Explore the bone metabolism characteristics of premature ovarian insufficiency.
Read the detailed description
Explore the bone metabolism characteristics of premature ovarian insufficiency, indexes includes serum levels of TRACP-5b and BALP, BMD values of lumbar spine L1-L4, left and right hip, left and right femoral neck et.al.
- Being tested
- Testing the serum levels of bone metabolic markers
- Medical subject headings
- Primary Ovarian Insufficiency, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing the serum levels of bone metabolic markersDiagnostic test
Testing serum levels of TRACP-5b and BALP, BMD values of lumbar spine L1-L4, left and right hip, left and right femoral neck et.al.
| Study group | Role | What they receive |
|---|---|---|
| POI Group | The patients with premature ovarian insufficiency Receives: Diagnostic Test: Testing the serum levels of bone metabolic markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
tartrate resistant acid phosphatase-5b, TRACP-5b
Blood samples are collected when enrolled.
Measured: On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)
Secondary outcomes (2)
bone specific alkaline phosphatase, BALP
Blood samples are collected when enrolled.
Measured: On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)
bone mineral density, BMD
BMD values of lumbar spine L1-L4, left and right hip, left and right femoral neck
Measured: On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian InsufficiencyStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shi Yun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shi Yun, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339489
- Sponsor's protocol ID
- 2022DZMEC-PG-34
- Acronym
- POI
- Status last verified
- Jun 2024
- First submitted
- 25 Mar 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Bone Metabolism Characteristics of Premature Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT06339489
- Acronym / sponsor ID
- POI / 2022DZMEC-PG-34
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shi YunUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 1 Apr 2024 (actual)
- 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.
Explore the bone metabolism characteristics of premature ovarian insufficiency.
Detailed description
Explore the bone metabolism characteristics of premature ovarian insufficiency, indexes includes serum levels of TRACP-5b and BALP, BMD values of lumbar spine L1-L4, left and right hip, left and right femoral neck et.al.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POI Group | – | Diagnostic Test: Testing the serum levels of bone metabolic markersThe patients with premature ovarian insufficiency |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- females with premature ovarian insufficiency
Key inclusion criteria (1 listed)
- Patients diagnosed by Western medicine with premature ovarian insufficiency. 18 ≤ patients' age ≤ 39 years;. Patients who voluntarily participate in this study, sign an informed consent form.
Key exclusion criteria (4 listed)
- Patients with congenital gonadal dysplasia or a family history similar to "early menopause".
- POI patients with acquired organic lesions or ovarian surgery. Patients who have taken Western or herbal medicine artificial cycle therapy or other endocrine therapy in the past three months.
- Patients with serious primary diseases and mental disorders such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system.
- Patients who are breastfeeding or pregnant.
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 |
|---|---|---|
| Testing the serum levels of bone metabolic markersTesting serum levels of TRACP-5b and BALP, BMD values of lumbar spine L1-L4, left and right hip, left and right femoral neck et.al. | Diagnostic test | POI Group |
Primary outcome
tartrate resistant acid phosphatase-5b, TRACP-5b
Time frame: On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)
Blood samples are collected when enrolled.
2 secondary outcomes
bone specific alkaline phosphatase, BALP
Time frame: On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)
bone mineral density, BMD
Time frame: On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, China
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 Premature Ovarian Insufficiency and Bone Diseases, Metabolic, run by Shi Yun at 1 site in China.
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 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 25 Jun 2024. 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tartrate resistant acid phosphatase-5b, TRACP-5b (time frame: On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)). 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 25 Jun 2024.