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

May 6, 2018 updated by: You-Jia Xu, Second Affiliated Hospital of Soochow University

A Observational Study to Investigate the Relationship of Levels of Serum Ferritin, Bone Mineral Density and Bone Metabolism in Chinese Healthy Postmenopausal Women

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Jiagnsu
  - Suzhou, Jiagnsu, China, 215004
    - Second Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

Inclusion Criteria:

healthy postmenopausal women
subjects aged 55 years or older

Exclusion Criteria:

subjects with acute or chronic inflammatory or infectious diseases
chronic liver or renal diseases
history of transfusion or iron therapy in the previous year
history of drug therapy such as bisphosphonates and glucocorticoids, which might have affected bone metabolism
subjects with hematonosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The concentrations of serum ferritin Time Frame: 12 months	Serum ferritin was assayed by an immunoradiometric method.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months
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.	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Soochow University

Investigators

Study Chair: Youjia Xu, Ph.D,M.D., Second Affiliated Hospital of Soochow University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Anticipated)

April 30, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

April 15, 2018

First Submitted That Met QC Criteria

April 27, 2018

First Posted (Actual)