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NCT06339489 Clinical Trial

The Bone Metabolism Characteristics of Premature Ovarian Insufficiency

Bone Diseases, Metabolic Clinical Trial

— POI  

Official title:
Explore the Bone Metabolism Characteristics of Premature Ovarian Insufficiency

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06339489
Other study ID # 2022DZMEC-PG-34
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date February 1, 2025

Study information
Verified date March 2024
Source Dongzhimen Hospital, Beijing
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Explore the bone metabolism characteristics of premature ovarian insufficiency.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date February 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 39 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
China Dongzhimen Hospital, Beijing University of Chinese Medicine Beijing

Sponsors (1)
Lead Sponsor Collaborator
Shi Yun

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary tartrate resistant acid phosphatase-5b, TRACP-5b Blood samples are collected when enrolled. On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Secondary bone specific alkaline phosphatase, BALP Blood samples are collected when enrolled. On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)
Secondary bone mineral density, BMD 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)
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