NCT03512743

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

May 11, 2018

Status Verified

April 1, 2018

Enrollment Period

12 months

First QC Date

April 15, 2018

Last Update Submit

May 6, 2018

Conditions

Postmenopausal OsteoporosisIron Metabolism Disorders

Keywords

bone mineral densitybone turnover markersferritin

Outcome Measures

Primary Outcomes (1)

  • The concentrations of serum ferritin

    Serum ferritin was assayed by an immunoradiometric method.

    12 months

Secondary Outcomes (2)

  • Bone turnover markers(BTMs)

    12 months

  • Bone mineral density(BMD)

    12 months

Eligibility Criteria

Age55 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population consists of postmenopausal women aged 55 years or older who shall undergone comprehensive routine health examinations at the Second Affiliated Hospital of Soochow University, and on whom BMD, serum ferritin concentrations and bone turnover markers will be measured.The visitors are usually healthy and receive extensive screening tests for early detection of malignancy, diabetes, osteoporosis, and other age-related disease.

You may qualify if:

  • healthy postmenopausal women
  • subjects aged 55 years or older

You may not qualify if:

  • subjects with acute or chronic inflammatory or infectious diseases
  • chronic liver or renal diseases
  • history of transfusion or iron therapy in the previous year
  • history of drug therapy such as bisphosphonates and glucocorticoids, which might have affected bone metabolism
  • subjects with hematonosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital of Soochow University

Suzhou, Jiagnsu, 215004, China

Location

Related Publications (4)

  • 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.

    PMID: 22525981BACKGROUND

  • 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.

    PMID: 25522357BACKGROUND

  • 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.

    PMID: 19527179BACKGROUND

  • 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.

    PMID: 26116610BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood serum

MeSH Terms

Conditions

Osteoporosis, PostmenopausalIron Metabolism Disorders

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Youjia Xu, Ph.D,M.D.

    Second Affiliated Hospital of Soochow University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 15, 2018

First Posted

May 1, 2018

Study Start

May 1, 2018

Primary Completion

April 30, 2019

Study Completion

June 1, 2019

Last Updated

May 11, 2018

Record last verified: 2018-04

Locations

CN(1)