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

NCT ID: NCT03512743

Last Updated: 2018-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postmenopausal Osteoporosis Iron Metabolism Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role lead

Responsible Party

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You-Jia Xu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Youjia Xu, Ph.D,M.D.

Role: STUDY_CHAIR

Second Affiliated Hospital of Soochow University

Locations

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Second Affiliated Hospital of Soochow University

Suzhou, Jiagnsu, China

Site Status

Countries

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China

References

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Li GF, Pan YZ, Sirois P, Li K, Xu YJ. Iron homeostasis in osteoporosis and its clinical implications. Osteoporos Int. 2012 Oct;23(10):2403-8. doi: 10.1007/s00198-012-1982-1. Epub 2012 Apr 14.

Reference Type BACKGROUND
PMID: 22525981 (View on PubMed)

Chon SJ, Choi YR, Roh YH, Yun BH, Cho S, Choi YS, Lee BS, Seo SK. Association between levels of serum ferritin and bone mineral density in Korean premenopausal and postmenopausal women: KNHANES 2008-2010. PLoS One. 2014 Dec 18;9(12):e114972. doi: 10.1371/journal.pone.0114972. eCollection 2014.

Reference Type BACKGROUND
PMID: 25522357 (View on PubMed)

Jian J, Pelle E, Huang X. Iron and menopause: does increased iron affect the health of postmenopausal women? Antioxid Redox Signal. 2009 Dec;11(12):2939-43. doi: 10.1089/ars.2009.2576.

Reference Type BACKGROUND
PMID: 19527179 (View on PubMed)

Xiao W, Beibei F, Guangsi S, Yu J, Wen Z, Xi H, Youjia X. Iron overload increases osteoclastogenesis and aggravates the effects of ovariectomy on bone mass. J Endocrinol. 2015 Sep;226(3):121-34. doi: 10.1530/JOE-14-0657. Epub 2015 Jun 26.

Reference Type BACKGROUND
PMID: 26116610 (View on PubMed)

Other Identifiers

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Sencond Soochow U

Identifier Type: -

Identifier Source: org_study_id

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