Condition category
Musculoskeletal Diseases
Date applied
19/06/2017
Date assigned
01/09/2017
Last edited
26/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Osteoporosis (weak or brittle bones) is common and often missed. Group clinics can be an option to try and diagnose this condition. Group clinics are effective and efficient in patients with arthritis (a type of swelling in the joints); however it is unsure if group clinics work for osteoporosis. The aim of this study is to see if a group clinic led by a pharmacist were as effective as usual care for people with osteoporosis.

Who can participate?
Adults over 50 with high fracture risk.

What does the study involve?
Participants are randomly allocated using a random number table to either the intervention or the control group. Those in the intervention group attend a single Pharmacist-led group clinic. Those in the control group receive the usual care, which is a single consultation delivered by Pharmacist. Participants are followed up for 12 months for medication use.

What are the possible benefits and risks of participating?
There are no benefits with participating. There are no direct risks, however participants may not like being seen in a group setting.

Where is the study run from?
This study is being run by Northumbria Healthcare (UK) and takes place practices in Northumberland CCG (UK).

When is the study starting and how long is it expected to run for?
August 2010 to August 2018

Who is funding the study?
1. National Osteoporosis Society (UK)
2. National Institute for Health Research (UK)

Who is the main contact?
1. Dr Fraser Birrell (Scientific)
Fraser.birrell@newcastle.ac.uk
2. Mrs Norma Cardill (Public)
norma.cardill@northumbria-healthcare.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Norma Cardill

ORCID ID

Contact details

Northumbria Healthcare NHS Foundation Trust
Rake Lane
North Shields
NE29 8NH
United Kingdom
+44 1670 529903
norma.cardill@northumbria-healthcare.nhs.uk

Type

Scientific

Additional contact

Dr Fraser Birrell

ORCID ID

Contact details

Northumbria Healthcare NHS Foundation Trust
Rake Lane
North Shields
NE29 8NH
United Kingdom
+44 1670 529903
Fraser.Birrell@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12765

Study information

Scientific title

Northumbria Osteoporosis Project: A randomised controlled trial of managing patients needing bone protection treatment through group clinics vs usual one to one care

Acronym

Study hypothesis

There will be no significant difference between medicines adherence as measured by Mean Possession Ratio (MPR) when compared with usual care (1:1 clinic), in patients being prescribed bisphosphonates for fracture prevention.

Ethics approval

NRES Committee North East - Newcastle & North Tyneside 1, 21/12/2010, 10/H0906/88

Study design

Randomised; Both; Design type: Not Specified, Not Specified, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Musculoskeletal disorders, Primary sub-specialty: Metabolic Bone Disease

Intervention

Participants with high risk of fracture were identified by their practice. They were sent a letter to invite them to take part in the study. Those accepting were randomised to group clinic or usual care and seen once. In either setting they had education about osteoporosis and prescribed standard treatment.

Participants are randomly allocated using a random number table to either the intervention or the control group. Those in the intervention group attend a single Pharmacist-led group clinic. Those in the control group receive the usual care, which is a single consultation delivered by Pharmacist. Participants are followed up for 12 months for medication use.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Mean possession ratio (MPR) of bisphosphonates is measured using practice prescription records at 12 months

Secondary outcome measures

1. Persistence with treatment is the time (in months) before the drug is no longer requested measured using practice prescription records by month up to 12 months
2. Patient satisfaction with group clinics, enabling factors and active ingredients were explored with qualitative interviews of osteoporosis group clinic participants and comparison with an established, but co-designed and therefore evolving inflammatory arthritis group clinic model
3. Cost analysis of the intervention was restricted to staff costs of, as assumptions of other costs being equivalent were met

Overall trial start date

24/08/2010

Overall trial end date

31/08/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients identified as high risk of an osteoporotic fracture, needing treatment
2. Patients aged 50 years and over
3. Patients giving informed consent to the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 214; UK Sample Size: 214

Participant exclusion criteria

1. Patients not eligible for first line treatment as defined by North of Tyne Osteoporosis Guidance (encompassing FRAX calculation and NOGG guideline)
2. Patients not wishing to participate in the study
3. Patients unable to consent to participate in the study
4. Patient contraindications to bisphosphonates (upper gastrointestinal problems, severe impairment GFR<35ml/min, previous intolerance)
5. Terminally ill patients
6. Housebound patients

Recruitment start date

01/06/2012

Recruitment end date

31/07/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northumbria Healthcare NHS Foundation Trust
North Shields
NE29 8NH
United Kingdom

Trial participating centre

Bedlingtonshire Medical Group
Bedlington
NE22 6JX
United Kingdom

Trial participating centre

Laburnum Surgery
Ashington
NE63 0XX
United Kingdom

Trial participating centre

Lintonville Medical Group
Lintonville Terrace
Ashington
NE63 9UT
United Kingdom

Sponsor information

Organisation

North Tyneside General Hospital

Sponsor details

Northumbria Healthcare NHS Foundation Trust
Research & Development
Rake Lane
North Shields
NE29 8NH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Osteoporosis Society

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from wasim.baqir@nhs.net

Intention to publish date

31/08/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/10/2017: Internal review.