Contact information
Type
Scientific
Primary contact
Dr D.A. Eekman
ORCID ID
Contact details
Vrije University Medical Centre
Department of Rheumatology
4a-42
Boelelaan 1117
Amsterdam
1081 HV
Netherlands
+31 (0)20 444 3432
d.eekman@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from VU University Medical Center Ethics Board, Amsterdam, on the 21st June 2007 (ref: 2007/132).
Study design
Multicentre, parallel group clinical trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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%)
Secondary outcome measures
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.
Overall trial start date
01/09/2007
Overall trial end date
01/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
1650
Participant 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
Recruitment start date
01/09/2007
Recruitment end date
01/12/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Vrije University Medical Centre
Amsterdam
1081 HV
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (The Netherlands)
Sponsor details
Department of Rheumatology
Amsterdam
1081 BT
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list