Implementation of a strategy of osteoporosis screening in patients over 50 years of age with a first fracture

ISRCTN	ISRCTN52352361
DOI	https://doi.org/10.1186/ISRCTN52352361
Protocol serial number	N/A
Sponsor	Vrije University Medical Centre (VUMC) (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Submission date: 23/08/2007
Registration date: 23/08/2007
Last edited: 26/09/2007

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr D.A. Eekman
Scientific

Vrije University Medical Centre
Department of Rheumatology, 4a-42
Boelelaan 1117
Amsterdam
1081 HV
Netherlands

Phone	+31 (0)20 444 3432
Email	d.eekman@vumc.nl

Study information

Primary study design	Interventional
Study design	Multicentre, parallel group clinical trial
Secondary study design	Non randomised controlled trial
Scientific title
Study objectives	The nurse practitioner will actively approach all fracture patients above the age of 50 for screening and intensive treatment of osteoporosis. This will improve the number of fracture patients screened and treated for osteoporosis.
Ethics approval(s)	Ethics approval received from VU University Medical Center Ethics Board, Amsterdam, on the 21st June 2007 (ref: 2007/132).
Health condition(s) or problem(s) studied	Osteoporosis screening
Intervention	In the implementation group the patients will be screened for osteoporosis by Dual energy X-ray Absorptiometry (DXA) measurement, and a spine X-ray will be performed. At baseline and after 12 months a blood sample will be taken. At baseline, after 3, 6, 9 and 12 months questionnaires will be performed. The follow up period is 1 - 1.5 years (depending on the time it takes to include enough patients). Patients will be treated with anti-osteoporosis medication according to the CBO guidelines (first choice bisphosphonates). In the parallel group only the questionnaires will be performed.
Intervention type	Other
Primary outcome measure(s)	1. Percentage of patients with a fracture of 50 years and older that is screened by a fracture nurse for osteoporosis (the goal is 70%) 2. Percentage of patients that are screened and treated and still use their medication after one year (the goal is 70%)
Key secondary outcome measure(s)	1. Percentage of patients that present with a fracture within a year of the initial fracture 2. Percentage screened patients and percentage compliant patients in the fracture nurse group compared to the parallel group 3. The costs and barriers to implement a fracture nurse The final follow up will take place after one year, the patients will be contacted every three months.
Completion date	01/12/2009

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	1650
Key inclusion criteria	All patients 50 years of age or older, who have a clinical fracture and a low Bone Mineral Density (BMD) defined as a T score greater than or equal to 2.
Key exclusion criteria	1. Patients with a fracture after a traffic accident 2. Patients with a pathological fracture 3. Patients with fractures of hand, foot or scull 4. Serious co-morbidity or dementia 5. Incapable of visiting the out patient clinic
Date of first enrolment	01/09/2007
Date of final enrolment	01/12/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Vrije University Medical Centre

Amsterdam
1081 HV
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan