The Bone Metabolism Characteristics of Premature Ovarian Insufficiency

NCT06339489 | Recruiting

• 1 other identifier: 2022DZMEC-PG-34
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Explore the bone metabolism characteristics of premature ovarian insufficiency.

Conditions

Premature Ovarian Insufficiency; Bone Diseases, Metabolic; Bone Mineral Density

Outcome Measures

Primary Outcomes (1)

• tartrate resistant acid phosphatase-5b, TRACP-5b

  Blood samples are collected when enrolled.

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

Secondary Outcomes (2)

• bone specific alkaline phosphatase, BALP

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

• bone mineral density, BMD

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

Study Arms (1)

POI Group

The patients with premature ovarian insufficiency

Diagnostic Test: Testing the serum levels of bone metabolic markers

Interventions

Testing the serum levels of bone metabolic markers DIAGNOSTIC_TEST

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.

POI Group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Gender Eligibility Details: biological sex
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

females with premature ovarian insufficiency

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shi Yun: lead

Study Sites (1)

Dongzhimen Hospital, Beijing University of Chinese Medicine

Beijing, China

RECRUITING

MeSH Terms

Conditions

Primary Ovarian Insufficiency; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

CN (1)