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Strategies to Treat Osteoporosis Following a Fragility Fracture (OPTIMUS)
This study is currently recruiting participants.
Verified by Universitaire de Sherbrooke, August 2007
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
  Purpose

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

MedlinePlus related topics: Fractures Osteoporosis
U.S. FDA Resources
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)

Further study details as provided by Universitaire de Sherbrooke:

Primary Outcome Measures:
  • Percentage of patients initiating an effective osteoporosis treatment [ Time Frame: Over the year following the clinical fracture ]
  • Percentage of patients pursuing an effective osteoporosis treatment [ Time Frame: At one year after the clinical fracture ]

Secondary Outcome Measures:
  • Availability of serum measures of bone degradation will improve adherence to treatment [ Time Frame: At one year after clinical fracture ]

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)


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 50 years of age
  • Fragility fracture
  • Consulting an orthopedic surgeon at the CHUS for treatment of the fracture

Exclusion Criteria:

  • No Primary Care Practitioner
  • Severe co-morbidity requiring specialized care
  • Failure to consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512499

Contacts
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

Locations
Canada, Quebec
Centre hospitalier universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Principal Investigator: Gilles Boire, MD MSc            
Principal Investigator: François Cabana, MD            
Sponsors and Collaborators
Universitaire de Sherbrooke
Merck Frosst Canada Ltd.
Procter and Gamble
Aventis Pharmaceuticals
Novartis
Investigators
Principal Investigator: Gilles Boire, MD MSc Université de Sherbrooke
Principal Investigator: François Cabana, MD Université de Sherbrooke
  More Information

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

Keywords provided by Universitaire de Sherbrooke:
Osteoporosis
Fragility fractures
Fracture clinics
Orthopedic surgeons

Study placed in the following topic categories:
Musculoskeletal Diseases
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on January 15, 2009