VDOP: Reanalysis of a completed clinical trial using DXA-RFA
Research type
Research Study
Full title
Vitamin D in Older People (VDOP): Reanalysis of a completed clinical trial dataset using a novel imaging data analysis tool, Dual Energy X-Ray Absorptiometry Region Free Analysis (DXA-RFA).
IRAS ID
227313
Contact name
J. Mark Wilkinson
Contact email
Sponsor organisation
University of Sheffield
Clinicaltrials.gov Identifier
12/NE/0050, Original VDOP REC Reference
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The Vitamin D in Older People (VDOP) study was an intervention study in healthy individuals over the age of 70. The participants were split into three groups and given three different doses of an oral Vitamin D supplement once a month with a primary objective of observing the change in bone mineral density (BMD) in the hip as measured by Dual-energy X-ray Absorptiometry (DXA).
DXA-Region Free Analysis (DXA-RFA) is a novel image analysis technique allowing high-resolution analysis of DXA scans. The conventional analysis technique is performed regionally, where BMD data acquired by DXA is averaged across regions of the target bone. DXA-RFA allows a pixel-level analysis approach, which accounts for anatomic variability between individuals and variation in the positioning of individuals to be scanned, and allows observation of BMD changes in precise locations of the bone. When comparing two scans at different times, this may elucidate longitudinal changes which can be measured by their areal size and by their magnitude.
The VDOP dataset was previously analysed using a conventional DXA approach. He we will conduct an exploratory analysis using DXA RFA to re-analyse the anonymised VDOP DXA dataset using DXA RFA to determine whether the increased resolution afforded by the new method will demonstrate pixel-level BMD changes not identified using the previous analysis method.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
17/SW/0120
Date of REC Opinion
26 May 2017
REC opinion
Favourable Opinion