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RecruitingNCT06339489POIUpdated Jun 25, 2024

The Bone Metabolism Characteristics of Premature Ovarian Insufficiency

An observational study in Premature Ovarian Insufficiency, Bone Diseases, Metabolic and Bone Mineral Density, sponsored by Shi Yun. Recruiting at 1 site in China. Open to female participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2024-06-25.

Sponsored by Shi Yun · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years to 39 Years
Sex
Female
01

Study summary

Explore the bone metabolism characteristics of premature ovarian insufficiency.

Read the 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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

females with premature ovarian insufficiency

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

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.

04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • POI Group

    The patients with premature ovarian insufficiency

    Diagnostic Test: Testing the serum levels of bone metabolic markers

Interventions

  • Diagnostic testTesting 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.

05

What researchers measure

Primary outcomes

  1. tartrate resistant acid phosphatase-5b, TRACP-5b

    Blood samples are collected when enrolled.

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

Secondary outcomes

  1. bone specific alkaline phosphatase, BALP

    Blood samples are collected when enrolled.

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

  2. bone mineral density, BMD

    BMD values of lumbar spine L1-L4, left and right hip, left and right femoral neck

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

06

Study locations

1 of 1 sites recruiting
  • Dongzhimen Hospital, Beijing University of Chinese Medicine
    Beijing, China
    • Xueting Han · Contact · dzmyyec@126.com · +861084012709
    • Yun Shi, phD · Principal investigator
    • Ke Xu, Master · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06339489
Lead sponsor
Shi Yun
Responsible party
Shi Yun (Sponsor-Investigator, Dongzhimen Hospital, Beijing) — Sponsor-investigator
First posted
Apr 1, 2024
Start date
Apr 1, 2024
Primary completion
Dec 1, 2024 (estimated)
Completion
Feb 1, 2025 (estimated)
Last update
Jun 25, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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