Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Universitaire de Sherbrooke Merck Frosst Canada Ltd. Procter and Gamble Aventis Pharmaceuticals Novartis |
---|---|
Information provided by: | Universitaire de Sherbrooke |
ClinicalTrials.gov Identifier: | NCT00512499 |
Osteoporosis is a very frequent and easily treatable disease. Rates of treatment of affected patients is very low, as few high risk patients initiate treatment and only a minority of those pursue treatment for long enough time to prevent fractures. Patients presenting a fragility fracture after 50 years of age are at high risk of osteoporosis and may represent the ideal group of patients in which intervention aimed at improving initiation and persistence on treatment will be most effective.
Our first hypothesis is that the availability of a dedicated nurse practitioner to identify patients with fragility fractures among patients presenting at fracture clinics of orthopedic surgeons will increase markedly the rate of identification of osteoporosis.
Our second hypothesis is that giving to both the patient and its primary health practitioner (PHP) the patient's clinical, biological and radiological data along with individualized care suggestions will yield significantly better results than giving to the patient and its PHP generic information on osteoporsis risk, investigation and traetment.
Condition | Intervention |
---|---|
Osteoporosis Fragility Fractures |
Behavioral: Control group Behavioral: Minimal Intervention Behavioral: Intensive Intervention |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Ostéoporose et Fractures Périphériques : Traitement et Investigation Multidisciplinaires au chUS (Osteoporosis and Peripheral Fractures: Treatment and Investigation Multidisciplinary at the chUS) |
Estimated Enrollment: | 1800 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | February 2010 |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
CONTROL GROUP (first year only; maximum 300 patients): patients seen by CHUS orthopedists at the Hôtel-Dieu site, where no nurse coordinator is available. INTERVENTION: to determine by questionnaire that osteoporosis is likely, and to inform verbally the patient of this information while suggesting to consult his/her family physician for appropriate investigation and treatment. This single intervention is unlikely to modify significantly the rate of treatment of patients compared to No intervention (the prevalence observed in ROCQ). However, if it does, this information will be extremely useful to know as this represents a very low-cost intervention. After 8 months, patients still untreated and willing to be treated will be transferred to the Intensive Intervention. |
Behavioral: Control group
Informing patient that fracture probably of fragility origin and suggesting to consult primary care practitioner. After 8 months, if not treated, Intensive intervention will be offered
|
2: Active Comparator
MINIMAL INTERVENTION GROUP: 1/2 of patients, randomly selected. INTERVENTION: A nurse coordinator will identify patients with fragility fractures and inform the patient about osteoporosis as the cause of the fracture, the benefit of treatment, and the options of treatment adapted to the individual patient. Written information will be sent to his/her family physician containing a presumed osteoporosis diagnosis, investigation to be performed, correct interpretation of any osteodensitometry results in the context of a fragility fracture, the options of treatment, and alternatives if the first prescriptions are not tolerated or stopped. Intervention |
Behavioral: Minimal Intervention
Multiple layers of intervention will be added: results of the basic blood investigation for osteoporosis will be transmitted to the family physician with a personal letter explaining the importance of seeing the patient rapidly and indicating the urgency of initiating a treatment and indicating detailed instructions of treatment. The patient will be called at 4, 8, 12,16 and 24 months to monitor drug adherence, correct inadequate intake, and try to improve adherence. If the patient is not taking an adequate treatment at 4, 8 or 12 months, a letter will be sent again to the family physician asking to treat the patient according to recommendations.
|
3: Experimental
INTENSIVE INTERVENTION GROUP: 1/2 of patients, randomly selected Multiple layers of intervention will be added: results of the basic blood investigation for osteoporosis will be transmitted to the family physician with a personal letter explaining the importance of seeing the patient rapidly and indicating the urgency of initiating a treatment and indicating detailed instructions of treatment. The patient will be called at 4, 8, 12,16 and 24 months to monitor drug adherence, correct inadequate intake, and try to improve adherence. If the patient is not taking an adequate treatment at 4, 8 or 12 months, a letter will be sent again to the family physician asking to treat the patient according to recommendations.
|
Behavioral: Intensive Intervention
INTENSIVE INTERVENTION GROUP: 1/2 of patients, randomly selected results of the basic blood investigation for osteoporosis will be transmitted to the family physician with a personal letter explaining the importance of seeing the patient rapidly and indicating the urgency of initiating a treatment and indicating detailed instructions of treatment. The patient will be called at 4, 8, 12,16 and 24 months to monitor drug adherence, correct inadequate intake, and try to improve adherence. If the patient is not taking an adequate treatment at 4, 8 or 12 months, a letter will be sent again to the family physician asking to treat the patient according to recommendations. Sequential serum will be stored frozen in order to measure levels of blood markers of bone metabolism (at a later date) |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Noémie Poirier, BSc | 18193461110 ext 12868 | npoirier.chus@ssss.gouv.qc.ca |
Contact: Line Larrivée, RN | 18193461110 ext 1889 | llarrivee.chus@ssss.gouv.qc.ca |
Canada, Quebec | |
Centre hospitalier universitaire de Sherbrooke | Recruiting |
Sherbrooke, Quebec, Canada, J1H 5N4 | |
Principal Investigator: Gilles Boire, MD MSc | |
Principal Investigator: François Cabana, MD |
Principal Investigator: | Gilles Boire, MD MSc | Université de Sherbrooke |
Principal Investigator: | François Cabana, MD | Université de Sherbrooke |
Study ID Numbers: | 06-091 |
Study First Received: | August 3, 2007 |
Last Updated: | August 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00512499 |
Health Authority: | Canada: Ethics Review Committee |
Osteoporosis Fragility fractures Fracture clinics Orthopedic surgeons |
Musculoskeletal Diseases Fractures, Bone Wounds and Injuries Disorders of Environmental Origin |
Osteoporosis Bone Diseases, Metabolic Bone Diseases |