Pain in Paget's disease
| ISRCTN | ISRCTN16335935 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16335935 |
| IRAS number | 232314 |
| Secondary identifying numbers | IRAS 232314, CPMS 41974 |
- Submission date
- 10/05/2021
- Registration date
- 14/06/2021
- Last edited
- 03/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Paget's disease of bone disrupts the normal cycle of bone renewal, causing bones to become weakened and possibly deformed. It's a fairly common condition in the UK, particularly in older people. It's rare in people under 50 years of age.
Bone pain is the most common symptom in patients with Paget's disease of bone (PDB), affecting around 73% of patients that come to clinical attention. However, the reason that pain occurs in some patients and not others is not understood. This study will look at a number of different potential factors, including: DNA and RNA analysis, the presence of markers of bone turnover in the blood, gut and mouth microbiomes, physical activity levels, diet, quality of life measures, and sensory testing.
Who can participate?
Anyone with a diagnosis of Paget's Disease of Bone who is over the age of 18 and is willing and able to comply and consent with the study protocol.
What does the study involve?
The study visit lasts approximately 90 minutes and involves blood samples being taken, questionnaires being answered and quantitative sensory testing being undertaken to compare sensory differences above affected and unaffected bone.
What are the possible benefits and risks of participating?
There are no direct benefits to participants themselves. There is a small risk of bruising during venepuncture.
Where is the study run from?
Institute of Genetics and Cancer, University of Edinburgh (UK)
When is the study starting and how long is it expected to run for?
January 2018 to December 2022
Who is funding the study?
The Paget's Association (UK)
Who is the main contact?
Kathryn Berg, kathryn.berg@ed.ac.uk
Contact information
Public
N3.12 Centre for Genomic and Experimental Medicine
Institute for Genetics and Molecular Medicine, University of Edinburgh
Crewe Road South
Edinburgh
EH4 2XU
United Kingdom
 ORCID ID |
0000-0002-5972-4009 |
|---|---|
| Phone | +44 (0)1316518726 |
| kathryn.berg@ed.ac.uk |
Study information
| Study design | Cross-sectional observational multi-centre study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | ISRCTN16335935_PIS_v4.0_05Apr2019.docx |
| Scientific title | Deciphering the mechanisms of pain in Paget's disease of bone |
| Study acronym | PiP |
| Study objectives | The aim of this study is to document the frequency with which pain occurs and to explore the mechanisms of pain in a cohort study of up to 250 patients with PDB. The rationale for the study is to gain a greater understanding of why pain occurs in PDB and to identify biomarkers that might predict the occurrence or severity of pain. |
| Ethics approval(s) | Approved 05/02/2019, West of Scotland Research Ethics Committee 3 (Clinical Research and Development, West Glasgow Ambulatory Care Hospital, Dalnair Street, Glasgow, G3 8SJ, UK; +44 (0)141 314 0211; WoSREC3@ggc.scot.nhs.uk), ref: 18/WS/0236 |
| Health condition(s) or problem(s) studied | Paget's disease of bone (PDB) |
| Intervention | The study involves a single visit lasting approximately 90 minutes which involves blood samples being taken, questionnaires being answered and quantitative sensory testing being undertaken to compare sensory differences above affected and unaffected bone. |
| Intervention type | Mixed |
| Primary outcome measure | Pain is measured using the BPI questionnaire and a visual analogue scale (VAS) at a single time point |
| Secondary outcome measures | QST will measure sensory detection and pain thresholds above affected and unaffected bone at a single time point |
| Overall study start date | 01/01/2018 |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 250 |
| Total final enrolment | 168 |
| Key inclusion criteria | 1. Clinical diagnosis of PDB 2. Age of 18 years or older 3. Willing and able to give informed consent |
| Key exclusion criteria | 1. Unable to comply with study procedures. |
| Date of first enrolment | 09/06/2019 |
| Date of final enrolment | 01/09/2022 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Edinburgh
EH4 2XU
United Kingdom
Glasgow
G51 4TF
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Liverpool
L7 8XP
United Kingdom
Salford
M6 8HD
United Kingdom
Cardiff
CF24 0JT
United Kingdom
Manchester
M13 9WL
United Kingdom
Norwich
NR4 7UY
United Kingdom
London
HA6 4LP
United Kingdom
Sheffield
S5 7AU
United Kingdom
Leicester
LE1 5WW
United Kingdom
Nottingham
NG5 1PB
United Kingdom
Sponsor information
University/education
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Phone | +44(0)131 242 3330 |
|---|---|
| resgov@accord.scot | |
| Website | http://accord.scot/ |
"ROR" |
https://ror.org/01x6s1m65 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request (Kathryn Berg, kathryn.berg@ed.ac.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v4.0 | 05/04/2019 | 14/06/2021 | No | Yes |
| Protocol file | version v5.0 | 09/07/2019 | 14/06/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 30/09/2024 | 03/03/2025 | Yes | No |
Additional files
- ISRCTN16335935_PROTOCOL_v5.0_09Jul2019.doc
- Uploaded 14/06/2021
- ISRCTN16335935_PIS_v4.0_05Apr2019.docx
- Uploaded 14/06/2021
Editorial Notes
03/03/2025: Publication reference added.
29/09/2022: The total final enrolment was added.
14/06/2021: Uploaded protocol Version 5.0, 09 July 2019 (not peer reviewed). The participant information sheet has been uploaded.
13/05/2021: Trial's existence confirmed by West of Scotland Research Ethics Committee 3.
