Strategies to Treat Osteoporosis Following a Fragility Fracture (OPTIMUS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Procter and Gamble
Sanofi
Novartis
Amgen
Eli Lilly and Company
Servier
Warner Chilcott
Information provided by (Responsible Party):
Gilles Boire, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00512499
First received: August 3, 2007
Last updated: October 30, 2013
Last verified: October 2013
  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 osteoporosis risk, investigation and treatment.


Condition Intervention
Osteoporosis
Fractures
Behavioral: Control group
Behavioral: Minimal Intervention
Behavioral: Intensive Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Ostéoporose et Fractures Périphériques : Traitement et Investigation Multidisciplinaires au chUS (Osteoporosis and Peripheral Fractures: Treatment and Investigation Multidisciplinary at the chUS)

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Percentage of patients pursuing an effective osteoporosis treatment [ Time Frame: At one year after the clinical fracture ] [ Designated as safety issue: No ]
    Patients with fragility fracture seeing an orthopedic surgeon for care of the fracture are included. Patients are then followed up by phone to assess new fragility fractures and initiation and persistence on osteoporosis treatments


Secondary Outcome Measures:
  • Rate of recurrent fragility fractures according to the site of the inclusion fracture [ Time Frame: Up to 4 years after clinical fracture ] [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: February 2007
Estimated Study Completion Date: June 2016
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group 1
CONTROL GROUP (first year only; maximum 300 patients): patients seen by CHUS orthopedists at the Hôtel-Dieu site, where no nurse coordinator is available for inclusion. This is random but not randomized.
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
Active Comparator: Group 2

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.
Experimental: Group 3
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512499

Locations
Canada, Quebec
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Merck Sharp & Dohme Corp.
Procter and Gamble
Sanofi
Novartis
Amgen
Eli Lilly and Company
Servier
Warner Chilcott
Investigators
Principal Investigator: Gilles Boire, MD MSc Université de Sherbrooke
Principal Investigator: François Cabana, MD Université de Sherbrooke
  More Information

No publications provided

Responsible Party: Gilles Boire, MD, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT00512499     History of Changes
Other Study ID Numbers: 06-091
Study First Received: August 3, 2007
Last Updated: October 30, 2013
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 30, 2014