A pragmatic randomised clinical trial of the effectiveness and cost effectiveness of targeted population screening for low bone mineral density (BMD) in the prevention of neck of femur fractures

ISRCTN	ISRCTN11021925
DOI	https://doi.org/10.1186/ISRCTN11021925
Secondary identifying numbers	16039

Submission date: 29/04/2005
Registration date: 17/06/2005
Last edited: 27/09/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lee Shepstone
Scientific

School of Medicine, Health, Policy & Practice
University of East Anglia
Norwich
NR4 7TJ
United Kingdom

Phone	+44 (0)1603 592100
Email	L.Shepstone@uea.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Screening
Scientific title	A pragmatic randomised clinical trial of the effectiveness and cost effectiveness of targeted population screening for low bone mineral density (BMD) in the prevention of neck of femur fractures
Study acronym	SCOOP - SCreening for Osteoporosis in Older Persons
Study objectives	Screening for women aged 70-85 at high risk of osteoporotic fracture with appropriate treatment will reduce the incidence fractures
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Prevention of osteoporotic/fragility fractures
Intervention	Intervention is screening for high risk of fracture based upon self-reported risk factors and BMD measurements in some subjects. Those deemed to be at high risk will be recommended to their GP for appropriate treatment. Those in the control group will receive lifestyle advice only.
Intervention type	Other
Primary outcome measure	All fractures (excluding those of hands, feet, nose and skull), ascertained by self report and separately by interrogation of hospital accident and emergency (A&E), radiology and admissions systems in hospitals serving the identified populations.
Secondary outcome measures	Quality of Life, Mortality
Overall study start date	01/01/2005
Completion date	31/12/2010
Reason abandoned (if study stopped)	http://www.arc.org.uk/research/GrantDetail.asp?ID=18025

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target number of participants	800
Key inclusion criteria	Female, aged 70-85, resident in the study areas
Key exclusion criteria	1. Already on treatment for osteoporosis (other than Vitamin D and Calcium) 2. Unable to provide informed consent
Date of first enrolment	01/01/2005
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Medicine, Health, Policy & Practice

Norwich
NR4 7TJ
United Kingdom

Sponsor information

University of East Anglia (UK)
University/education

Watton Road
Norwich
NR4 7TJ
England
United Kingdom

"ROR"	https://ror.org/026k5mg93

Funders

Funder type

Charity

Arthritis Research Campaign 16039 (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/10/2012		Yes	No
Results article	results	24/02/2018		Yes	No

Editorial Notes

27/09/2018: Publication reference added.