Reference Interval of TRAP5b in Healthy Men and Women
Research type
Research Study
Full title
Establishing Gender Specific Reference Intervals of Tartrate Resistant Acid Phosphatase in Healthy Men and Women
IRAS ID
249829
Contact name
Richard Eastell
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Bones adapt through a process called bone turnover. There are chemicals that can be measured in the blood, that go up or down depending on how much bone turnover is happening at any given time. It is useful to measure these chemicals in a patient that has a potential problem with their bones to see if bone turnover is higher than expected, or to see if a patient has responded to treatments to strengthen bones by reducing the bone turnover.
The chemical this study is measuring is called TRAP5b. In order to see if this chemical could have a use in assessing patients with bone disorders, this study aims to define what a normal value might be. Normal is a range of values for this chemical in the blood, obtained when the bones are at their most stable in life. This information is not yet known as a new method of measuring TRAP5b in the blood is currently not in use by medical practitioners assessing bone, yet it has advantages over some other chemicals that are routinely used.
The study participants will be volunteers that fulfill the criteria of having bones at the most stable point of life. We require 240 volunteers divided equally between both male and female gender who have no medical conditions affecting their bones.
They will attend the Clinical Research Facility on one occasion.
They will have a blood sample taken at two time points to measure the TRAP5b chemical before and after eating. Through a health and lifestyle questionnaire, we will check information that may influence the result of the TRAP5b. By performing other tests on the blood we will check for conditions that could effect how normal the measurement is. If the other blood tests show a medically important result, the volunteer's GP will be informed.
REC name
London - Bromley Research Ethics Committee
REC reference
19/LO/0415
Date of REC Opinion
20 Mar 2019
REC opinion
Further Information Favourable Opinion