Strategies to Treat Osteoporosis Following a Fragility Fracture

Summary

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.

Conditions

• Osteoporosis
• Fractures

Interventions

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

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.

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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Procter and Gamble

  collaborator INDUSTRY

• Sanofi

  collaborator INDUSTRY

• Novartis

  collaborator INDUSTRY

• Amgen

  collaborator INDUSTRY

• Eli Lilly and Company

  collaborator INDUSTRY

• Servier

  collaborator INDUSTRY

• Warner Chilcott

  collaborator INDUSTRY

• Université de Sherbrooke

  lead OTHER

Principal Investigators

• Gilles Boire, MD MSc · Université de Sherbrooke

• François Cabana, MD · Université de Sherbrooke

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

95 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-02-28

Primary Completion

2013-07-31

Completion

2016-07-31

Countries

• Canada

Study Locations