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

• ClinicalTrials.gov Identifier: NCT03512743
• Recruitment Status: Unknown
• First Posted: May 1, 2018
• Last Update Posted: May 11, 2018
• Sponsor: Second Affiliated Hospital of Soochow University
• Information provided by (Responsible Party): You-Jia Xu, Second Affiliated Hospital of Soochow University

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
Postmenopausal Osteoporosis; Iron Metabolism Disorders

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
• Estimated 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
• Estimated Primary Completion Date: April 30, 2019
• Estimated Study Completion Date: June 1, 2019

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. The concentrations of serum ferritin [ Time Frame: 12 months ]
   Serum ferritin was assayed by an immunoradiometric method.

Secondary Outcome Measures :

1. Bone turnover markers(BTMs) [ Time Frame: 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) [ Time Frame: 12 months ]
   Bone mineral density (BMD) in femur and lumbar spine were measured by dual-energy X-ray absorptiometry.

Biospecimen Retention:   Samples Without DNA

blood serum

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability 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.

Criteria

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

China, Jiagnsu

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

More Information

Publications:

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. Review.

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.

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.

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.

• 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: April 2018

Individual Participant Data (IPD) Sharing Statement:

• 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, Second Affiliated Hospital of Soochow University:

bone mineral density; bone turnover markers; ferritin

Additional relevant MeSH terms:

Osteoporosis; Osteoporosis, Postmenopausal; Metabolic Diseases; Iron Metabolism Disorders; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases