The Bone Metabolism Characteristics of Premature Ovarian Insufficiency (POI)

March 29, 2024 updated by: Shi Yun

Explore the Bone Metabolism Characteristics of Premature Ovarian Insufficiency

Explore the bone metabolism characteristics of premature ovarian insufficiency.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Explore the bone metabolism characteristics of premature ovarian insufficiency, indexes inclueds 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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Dongzhimen Hospital, Beijing University of Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

females with premature ovarian insufficiency

Description

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 informed consent form.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
POI Group
The patients with premature ovarian insufficiency
Diagnostic test: Testing 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tartrate resistant acid phosphatase-5b, TRACP-5b
Time Frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Blood samples are collected when enrolled.
On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone specific alkaline phosphatase, BALP
Time Frame: On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)
Blood samples are collected when enrolled.
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)
BMD values of lumbar spine L1-L4, left and right hip, left and right femoral neck
On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shi Yun

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022DZMEC-PG-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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