The Bone Metabolism Characteristics of Premature Ovarian Insufficiency

Recruiting

• Conditions: Bone Mineral Density; Premature Ovarian Insufficiency; Bone Diseases, Metabolic
• Interventions: Diagnostic Test: Testing the serum levels of bone metabolic markers

• Registration Number: NCT06339489
• Lead Sponsor: Shi Yun

Brief Summary

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 Timeline

• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-03-25
• Study Start: 2024-04-01
• Study First Posted: 2024-04-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-25
• Primary Completion: 2024-12-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
POI Group	Testing the serum levels of bone metabolic markers	The patients with premature ovarian insufficiency

Primary Outcome Measures

Name	Time	Method
tartrate resistant acid phosphatase-5b, TRACP-5b	On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)	Blood samples are collected when enrolled.

Secondary Outcome Measures

Name	Time	Method
bone specific alkaline phosphatase, BALP	On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)	Blood samples are collected when enrolled.
bone mineral density, BMD	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

Trial Locations

Locations (1)

Dongzhimen Hospital, Beijing University of Chinese Medicine; 🇨🇳 Beijing, China