|- candidate number||2696|
|- NTR Number||NTR1034|
|- Date ISRCTN created||23-aug-2007|
|- date ISRCTN requested||13-aug-2007|
|- Date Registered NTR||7-aug-2007|
|- Secondary IDs|| |
|- Public Title||Implementation of a strategy of osteoporosis screening in patients over 50 years of age with a first fracture|
|- Scientific Title||Implementation of a strategy of osteoporosis screening in patients over 50 years of age with a first fracture, with intensive treatment and follow-up by a nurse-practitioner to prevent recurrent fractures in those patients with diagnosed osteoporosis|
|- 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.|
|- Healt Condition(s) or Problem(s) studied||Osteoporosis, Implementation, Fracture , Nurse practitioner |
|- Inclusion criteria||All patients 50 years of age or older, who have a clinical fracture and a low BMD defined as a T score smaller or equal 2.|
|- 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 comorbidity or dementia
5. Incapable of visiting the out patient clinic|
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-sep-2007|
|- planned closingdate||1-dec-2009|
|- Target number of participants||1650|
|- Interventions||In the implementation group the patients will be screened for osteoporosis by 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 parallelgroup only the questionnaires will be performed.|
|- Primary outcome||Is it possible to improve routine detection and treatment of osteoporosis after an initial fracture?
1.Is it possible to increase the proportion of patients adequately screened and categorized as to the presence of osteoporosis from current practice of 5-40% to at least 70%?
2. In patients found to have osteoporosis, is it possible to:
a. start treatment in nearly all applicable patients?
b. maintain the proportion of patients still on anti osteoporotis treatment after 1 year at 70% of those starting treatment?|
|- Secondary outcome||1. Are the data on subsequent fracture rates compatible with a reduction to 4%?
2. Is the proportion of patients screened for osteoporosis with a DXA measurement significantly higher in the implementation group (with fracture nurse) than in the control group (without a fracture nurse; 'usual care')?
3. Is the proportion of patients still on anti osteoporosis treatment after 1 year significantly higher in the implementation group than in the control group?
4. What are the costs associated with the implementation of an osteoporosis nurse and how do these costs compare to the health benefits obtained.
5. What are the practical barriers encountered in trying to achieve the above mentioned goals?
6. What are the practical barriers in the implementation of an osteoporosis nurse, and how can these be overcome?|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||drs DA Eekman |
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. W.F. Lems|
|- Sponsor/Initiator ||VU University Medical Center, Depatment of Rheumatology |
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||The aging population frequently incurs osteoporotic fractures that are associated with high morbidity and increased mortality. Patients presenting with their first fracture are at high risk for reccurence. Patients aged 50 years or older are often diagnosed with osteoporosis after a DXA measurement. Effectieve and well tolerated drugs can reduce the incidence of new fractures roughly by half. In current practive, only a small percentage of patients presenting with a fracture above the age of 50 years are screened, and if needed treated, for osteoporosis.
In a few hospitals in the Netherlands a nurse practitioner is appointed as a central person, to screen and if needed treat, patients with fractures above the age of 50. Is it possible to improve routine detection and treatment of osteoporosis after an initial fracture by appointing a fracture nurse? In 4 hospitals a fracture nurse will be appointed, and in 4 hospitals patients will be treated according to usual care.
|- Main changes (audit trail)|
|- RECORD||7-aug-2007 - 27-aug-2007|