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
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Bone Mineral Density
• Menopause, Premature
• Metabolic Diseases
• Premature Birth
• Premature Ovarian Insufficiency
• Primary Ovarian Insufficiency

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)