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

Postmenopausal Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03512743
• Other study ID #: Sencond Soochow U
• Status: Enrolling by invitation
• Start date: May 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: April 2018
• Source: Second Affiliated Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: June 1, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Iron Metabolism Disorders
• Metabolic Diseases
• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Soochow University	Suzhou	Jiagnsu

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The concentrations of serum ferritin	Serum ferritin was assayed by an immunoradiometric method.	12 months
Secondary	Bone turnover markers(BTMs)	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).	12 months
Secondary	Bone mineral density(BMD)	Bone mineral density (BMD) in femur and lumbar spine were measured by dual-energy X-ray absorptiometry.	12 months