OOM
Research type
Research Study
Full title
Should we screen patients with OP and osteopenia for the presence of M protein
IRAS ID
273636
Contact name
Anurag Bharadwaj
Contact email
Sponsor organisation
Basildon and Thurrock University Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 5 months, 15 days
Research summary
Osteoporosis (OP) and osteopenia are characterized by low bone mass and increased risk of fractures. Secondary causes of low bone mass include monoclonal gammopathies. These are blood diseases characterised by the presence of monoclonal (M) protein which can be detected in the serum and/or urine. Data suggests variable prevalence of M protein in patients with osteoporosis ranging from 0 to 19.4%. A potentially large number of patients with these conditions maybe missed if screening is not done. Equally there is an argument for cost effectiveness. Monoclonal gammopathies include cancers e.g. multiple myeloma(MM) and precancerous conditions e.g. monoclonal gammopathy of undetermined significance(MGUS). All patients with MM require treatment to prevent potential complications including death. MGUS should be monitored for progression to MM or other cancer conditions. Hence the importance of identifying these patients early.
There is currently no consensus on whether or how to screen patients diagnosed with low bone mass for M protein. The available tests include serum protein electrophoresis, serum free light chain and urine Bence Jones proteins.
We are proposing this study to clarify the need for screening in this group of patients.
We plan to prospectively screen all patients diagnosed with OP or osteopenia in our clinics for M protein using the three available tests. This will be funded by Binding Site Group Ltd.
This is a local study to be carried out at one Trust site. We expect the study to last 24 weeks. Following informed consent, blood and urine samples will be collected from participants for analysis in the local laboratory. Participants and their general practitioners will be informed of results via letter. If M protein is identified, patients will be referred to the haematologists for further investigations and management. The potential need for this referral will be explained to participants before any study samples are collected.
REC name
London - Riverside Research Ethics Committee
REC reference
20/LO/0309
Date of REC Opinion
26 Mar 2020
REC opinion
Further Information Favourable Opinion