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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03512743
Other study ID # Sencond Soochow U
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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