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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Vrije University Medical Centre
Department of Rheumatology, 4a-42
Boelelaan 1117
Amsterdam
1081 HV
Netherlands
| Phone | +31 (0)20 444 3432 |
|---|---|
| d.eekman@vumc.nl |
Study information
| Study design | Multicentre, parallel group clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| 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 | 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 study start date | 01/09/2007 |
| Completion date | 01/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
1081 HV
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Rheumatology
Amsterdam
1081 BT
Netherlands
| Website | http://www.vumc.nl/english/ |
|---|---|
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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 |
