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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03512743

Enrollment

1000

Registered

2018-05-01

Start date

2018-05-01

Completion date

2019-06-01

Last updated

2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Metabolism Disorders, Postmenopausal Osteoporosis

Keywords

bone mineral density, bone turnover markers, ferritin

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

55 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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).
Bone mineral density(BMD)	12 months	Bone mineral density (BMD) in femur and lumbar spine were measured by dual-energy X-ray absorptiometry.

Countries

China

Outcome results