Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000594729
Ethics application status
Approved
Date submitted
23/05/2013
Date registered
27/05/2013
Date last updated
3/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 282532 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
iron deficiency 289197 0
iron overload 289241 0
normal iron stores 289242 0
bone metabolism 289243 0
Condition category
Condition code
Metabolic and Endocrine 289526 289526 0 0
Other metabolic disorders
Diet and Nutrition 289572 289572 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 287195 0
Not applicable
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289624 0
Comparative mean or median (depending on the distribution of the data) intact fibroblast growth factor 23 and C Terminal fibroblast growth factor 23 levels in the 3 groups of men with iron deficiency, normal iron stores and iron overload. Previous studies have compared either geometric mean FGF23 levels or log transformed median FGF23 levels. FGF23 levels ( intact and C-terminal) will be assessed by serum assay. Iron studies will be assessed by serum assay.
Timepoint [1] 289624 0
At the completion of analysis of results, once all the data have been collected, which is predicted to be approximately 10-12 months after the start of recruitment. This outcome will be assessed in each participant on one occasion only.
Secondary outcome [1] 302888 0
Comparative means or medians, depending on the distribution of the data, for associated markers of bone turnover and bone mass in the 3 groups of men with differing levels of iron stores - iron overload, iron deficiency or normal iron stores. The following bone markers will be assessed by serum or plasma assay: 25OH vitamin D, 1, 25 diOH vitamin D, PTH, P1NP, CTX, LH, SHBG, testosterone, EUC, CMP, CRP, LFTs, FE Studies, FGF23 intact, FGF23 C terminal. Full blood count will be assessed from this single blood sample. Tubular resorption of phosphate will be assessed on a single fasting urine sample. bone density will be assessed by DEXA.
Timepoint [1] 302888 0
Again, as for the primary outcome, this will occur once all the data have been collected and analysed, which is expected to be within 12 months from the start of recruitment. These outcomes will be assessed in each participant on one occasion only.
Secondary outcome [2] 303817 0
Comparative means or medians of body composition markers of lean and fat mass by DEXA (dual X-ray absorptiometry) for the 3 participant groups, depending on the distribution of the data.
Timepoint [2] 303817 0
To be performed around the time that blood and urine samples are taken

Eligibility
Key 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
Minimum age
35 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
For data that are normally distributed, analysis of variance (ANOVA) testing will be used to determine if differences between the 3 groups are statistically significant. If data are not normally distributed then the Kruskal-Wallis test for non-parametric analysis will be used to compare values and assess for differences between the 3 groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/07/2013
Actual
8/08/2013
Date of last participant enrolment
Anticipated
30/04/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1041 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 1042 0
Blue Mountains District ANZAC Memorial Hospital - Katoomba
Recruitment postcode(s) [1] 6904 0
2747 - Kingswood
Recruitment postcode(s) [2] 6905 0
2780 - Katoomba

Funding & Sponsors
Funding source category [1] 287322 0
Charities/Societies/Foundations
Name [1] 287322 0
Nepean Medical Research Foundation
Country [1] 287322 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Emily Hibbert
Address
Dept of Academic Medicine
Nepean Clinical School Building
Nepean Hospital
PO Box 63
Penrith,
NSW 2751.
Country
Australia
Secondary sponsor category [1] 286087 0
None
Name [1] 286087 0
Address [1] 286087 0
Country [1] 286087 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289315 0
Nepean Blue Mountains Local Health District Human Research Ethics Committee
Ethics committee address [1] 289315 0
Court Building, Ground Floor
Nepean Hospital
PO Box 63
Penrith
NSW 2751.
Ethics committee country [1] 289315 0
Australia
Date submitted for ethics approval [1] 289315 0
16/11/2012
Approval date [1] 289315 0
20/02/2013
Ethics approval number [1] 289315 0
Study 12/66 - HREC/12/NEPEAN/149

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40194 0
A/Prof Emily Hibbert
Address 40194 0
Dept of Academic Medicine
Nepean Clinical School Building
Nepean Hospital
PO Box 63
Penrith,
NSW 2751.

Country 40194 0
Australia
Phone 40194 0
+61 419 606 608
Fax 40194 0
+612 4734 1817
Email 40194 0
[email protected]
Contact person for public queries
Name 40195 0
A/Prof Emily Hibbert
Address 40195 0
Dept of Academic Medicine
Nepean Clinical School Building
Nepean Hospital
PO Box 63
Penrith,
NSW 2751.
Country 40195 0
Australia
Phone 40195 0
+612 4734 3294
Fax 40195 0
+612 4734 1817
Email 40195 0
[email protected]
Contact person for scientific queries
Name 40196 0
A/Prof Emily Hibbert
Address 40196 0
Dept of Academic Medicine
Nepean Clinical School Building
Nepean Hospital
PO Box 63
Penrith,
NSW 2751
Country 40196 0
Australia
Phone 40196 0
+612 4734 3294
Fax 40196 0
+612 4734 1817
Email 40196 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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