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

• Conditions: Iron Metabolism Disorders; Postmenopausal Osteoporosis

• Registration Number: NCT03512743
• Lead Sponsor: Second Affiliated Hospital of Soochow University

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.

Study Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-15
• Study First Submitted QC: 2018-04-27
• Study Start: 2018-05-01
• Study First Posted: 2018-05-01
• Last Update Submitted: 2018-05-06
• Last Update Posted: 2018-05-11
• Primary Completion: 2019-04-30
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The concentrations of serum ferritin	12 months	Serum ferritin was assayed by an immunoradiometric method.

Secondary Outcome Measures

Name	Time	Method
Bone mineral density(BMD)	12 months	Bone mineral density (BMD) in femur and lumbar spine were measured by dual-energy X-ray absorptiometry.
Bone turnover markers(BTMs)	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).

Trial Locations

Locations (1)

Second Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiagnsu, China