Study to determine levels of Fibroblast Growth Factor 23 and other associated markers of bone turnover in men with various iron store states of iron overload, iron deficiency and normal iron stores.

Study comparing differences in fibroblast growth factor 23 and other markers of bone turnover in men with various iron store states of iron overload, iron deficiency and normal iron stores.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12613000594729

Acronym

Nil

Enrollment

140

Registered

2013-05-27

Start date

2013-08-08

Completion date

2014-04-30

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

This study is a cross sectional case control study which will determine levels of FGF23, a phosphate regulatory protein produced by osteocytes in men with iron overload, using haemochromatosis as a model of iron overload, in men with iron deficiency and in men with normal iron stores. Associated markers of bone metabolism will be measured in blood and urine and bone densitometry and body composition studies will be performed by Dual X-ray absorptiometry.

Interventions

Not applicable- observational study Levels of FGF23, associated blood and urine markers of bone metabolism and bone mass are being studied. The duration of observation in each participant is at a single time point.

Eligibility

Sex/Gender

Male

Age

35 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

The study population will comprise males of age 35 years or greater who meet one of the following criteria: 1. iron overload due to haemochromatosis with ferritin > 300microg/l, the upper limit of the reference range or 2. normal iron studies 3. iron deficiency with ferritin < 30 microg/l ie. below the lower limit of the reference range

Exclusion criteria

1. Intercurrent proven evidence of cancer – as this will affect ferritin levels and interpretation and may alter FGF 23 2. Active infection- will affect ferritin levels and interpretation and may alter FGF 23 3. Chronic kidney disease with eGFR< 50 - as eGFR drops, FGF23 levels rise rapidly 4. Current glucocorticoid use, 5. Hypercalcaemia 6. Vitamin D deficiency with 25OH vitamin D level < 25 nmol/l

Outcome results