Clinical trial NCT03512743: Association of Serum Ferritin and Bone Mineral Density With Bone Metabolism in Chinese Healthy Postmenopausal Women
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postmenopausal Osteoporosis
Iron Metabolism Disorders
Keywords: bone mineral density
bone turnover markers
ferritin
Lead sponsor: Second Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: The concentrations of serum ferritin
timeFrame: 12 months
Secondary outcomes:
measure: Bone turnover markers(BTMs)
timeFrame: 12 months
measure: Bone mineral density(BMD)
timeFrame: 12 months
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Second Affiliated Hospital of Soochow University
state: Jiagnsu
Study officials:
affiliation: Second Affiliated Hospital of Soochow University
name: Youjia Xu, Ph.D,M.D.
role: STUDY_CHAIR
References:
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.
citation: 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.
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.
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.