Association of Serum Ferritin and Bone Mineral Density With Bone Metabolism in Chinese Healthy Postmenopausal Women

Sponsor
Second Affiliated Hospital of Soochow University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03512743
Collaborator
(none)
1,000
1
13
76.9

Study Details

Study Description

Brief Summary

Large amounts of experimental and animal evidence have confirmed that iron accumulation is associated with bone loss. However, it is still lack of the clinical studies relating iron accumulation to bone loss, especially in the pathological conditions during our Chinese. In this study, the investigators aim to assess the association between the levels of serum ferritin and bone mineral density in Chinese healthy postmenopausal women.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    For the past few years, an increasing number of in vitro studies show the association of iron accumulation with bone loss, particularly in postmenopausal women. And body iron accumulation is accurately reflected by levels of serum ferritin in clinic. The levels of serum ferritin among healthy women are about 13-150μg/L, and we give a definition of iron accumulation when serum ferritin range from 500μg/L to 1000 μg/L. How will the bone mineral density change in iron accumulation? The investigators intend to perform this study to explore and establish the relational function and logical function between serum ferritin, bone mineral density and biochemical markers of bone metabolism in Chinese healthy postmenopausal women.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Observational Study to Investigate the Relationship of Levels of Serum Ferritin, Bone Mineral Density and Bone Metabolism in Chinese Healthy Postmenopausal Women
    Actual Study Start Date :
    May 1, 2018
    Anticipated Primary Completion Date :
    Apr 30, 2019
    Anticipated Study Completion Date :
    Jun 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. The concentrations of serum ferritin [12 months]

      Serum ferritin was assayed by an immunoradiometric method.

    Secondary Outcome Measures

    1. Bone turnover markers(BTMs) [12 months]

      BTMs are classified as indices of either bone resorption or formation. During this study, we detect serum collagen type 1 cross-linked C-telopeptide(bone resorption marker) and Procollagen type I N-terminal propeptide(Bone formation marker).

    2. Bone mineral density(BMD) [12 months]

      Bone mineral density (BMD) in femur and lumbar spine were measured by dual-energy X-ray absorptiometry.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. healthy postmenopausal women

    2. subjects aged 55 years or older

    Exclusion Criteria:
    1. subjects with acute or chronic inflammatory or infectious diseases

    2. chronic liver or renal diseases

    3. history of transfusion or iron therapy in the previous year

    4. history of drug therapy such as bisphosphonates and glucocorticoids, which might have affected bone metabolism

    5. subjects with hematonosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Second Affiliated Hospital of Soochow University Suzhou Jiagnsu China 215004

    Sponsors and Collaborators

    • Second Affiliated Hospital of Soochow University

    Investigators

    • Study Chair: Youjia Xu, Ph.D,M.D., Second Affiliated Hospital of Soochow University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    You-Jia Xu, Professor, Second Affiliated Hospital of Soochow University
    ClinicalTrials.gov Identifier:
    NCT03512743
    Other Study ID Numbers:
    • Sencond Soochow U
    First Posted:
    May 1, 2018
    Last Update Posted:
    May 11, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by You-Jia Xu, Professor, Second Affiliated Hospital of Soochow University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 11, 2018