ClinicalTrials.gg
RecruitingNCT06339489POIUpdated Jun 25, 2024

The Bone Metabolism Characteristics of Premature Ovarian Insufficiency

An observational study in Premature Ovarian Insufficiency, Bone Diseases, Metabolic and Bone Mineral Density, sponsored by Shi Yun. Recruiting at 1 site in China. Open to female participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2024-06-25.

Sponsored by Shi Yun · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 7 months later.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years to 39 Years
Sex
Female
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Study summary

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.

02

Conditions studied

  • Premature Ovarian Insufficiency
  • Bone Diseases, Metabolic
  • Bone Mineral Density
03

In context

Primary Ovarian Insufficiency

181 studies on the registry are indexed under Primary Ovarian Insufficiency; 48 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 61 observational studies indexed under Primary Ovarian Insufficiency.

Browse Primary Ovarian Insufficiency studies →

Lead sponsor

Shi Yun is the lead sponsor of 7 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

females with premature ovarian insufficiency

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients diagnosed by Western medicine with premature ovarian insufficiency. 18 ≤ patients' age ≤ 39 years;. Patients who voluntarily participate in this study, sign an form.

Exclusion criteria

Exclusion Criteria:

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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • POI Group

    The patients with premature ovarian insufficiency

    Diagnostic Test: Testing the serum levels of bone metabolic markers

Interventions

  • Diagnostic testTesting the serum levels of bone metabolic markers

    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.

06

What researchers measure

Primary outcomes

  1. tartrate resistant acid phosphatase-5b, TRACP-5b

    Blood samples are collected when enrolled.

    Time frame: On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)

Secondary outcomes

  1. bone specific alkaline phosphatase, BALP

    Blood samples are collected when enrolled.

    Time frame: On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)

  2. bone mineral density, BMD

    BMD values of lumbar spine L1-L4, left and right hip, left and right femoral neck

    Time frame: On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)

07

Study locations

1 of 1 sites recruiting
  • Dongzhimen Hospital, Beijing University of Chinese Medicine
    Beijing, China
    Recruiting
    • Xueting Han · Contactdzmyyec@126.com · +861084012709
    • Yun Shi, phD · Principal investigator
    • Ke Xu, Master · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2024 (actual). Primary completion is estimated for Dec 2024, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 25, 2024
First posted
Apr 1, 2024
StartActual
Apr 1, 2024
Primary completionEst.
Dec 1, 2024
CompletionEst.
Feb 1, 2025
Last update
Jun 25, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06339489
Lead sponsor
Shi Yun
Responsible party
Shi Yun (Sponsor-Investigator, Dongzhimen Hospital, Beijing) — Sponsor-investigator
First posted
Apr 1, 2024
Start date
Apr 1, 2024
Primary completion
Dec 1, 2024 (estimated)
Completion
Feb 1, 2025 (estimated)
Last update
Jun 25, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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