Strategies to Treat Osteoporosis Following a Fragility Fracture
Condition: Osteoporosis; Fractures
MeSH terms: Osteoporosis; Fractures, Bone
Study type: Interventional

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.
    

Detailed description: 
      3- The OPTIMUS INTERVENTIONS

      3.1. PROGRAM GOALS and OBJECTIVES

      The OPTIMUS program is a health intervention whose aim is to increase the rate of long-term
      treatment of osteoporosis in patients with incident fragility fractures by addressing both
      initiation of treatment and persistence on treatment. Participation to the program will be
      voluntary.

      Specifically, the goals of OPTIMUS are:

        1. To increase the rate of initiation of treatment of osteoporosis following a fragility
           fracture in patients presenting to the CHUS. This rate is currently of about 30% in the
           Province of Quebec, according to the Recognizing Osteoporosis and its Consequences in
           Quebec (ROCQ) survey.

           We hope to demonstrate that a coordinated approach combining successful identification
           of patients with fragility fractures evaluated at the CHUS, quality information to the
           patients and to family physicians, rapid and appropriate management and initiation of
           treatment (see below) of these patients by general practitioners will lead to
           appropriate levels of treatment of osteoporosis after an episode of fracture. Our
           objective is to initiate treatment within 8 months after fracture in at least 50% of
           such patients who accept to participate with Minimal Intervention, 75% with Intensive
           Intervention, and 90% with Immediate treatment. The specifics of each Intervention are
           detailed below.

        2. Improve long-term adherence to treatment of osteoporosis following initiation of
           treatment after a fragility fracture. The current rate of persistence is 30-50% at 1
           year, most loss of persistence occurring during the first months.

      Initiating treatment of osteoporosis is important. However, long-term adherence to treatment
      of osteoporosis is very poor, with most discontinuation or erratic intake of medication
      observed during the first few months. Our objective is to maintain observance (i.e. intake of
      at least 80% of the doses of drugs according to patient questionnaires and to delivery of
      drugs by pharmacists) at one year in at least 80% of the patients who have initiated
      treatment. To that end, we will also evaluate whether disclosure of the results of
      measurements of blood markers of bone metabolism will influence patient adherence to
      treatment over time. The correlation of these measurements with results of phone follow up
      interviews and drug delivery by pharmacists as indicators of adherence will also be
      determined.

      Our objectives with the Intensive and Immediate treatment Interventions imply that 60% of
      patients with a fragility fracture would be treated for at least 16 months (i.e. 80% of the
      75% of patients who have initiated a treatment will adhere long-term). After 16 months of
      treatment, the rate of loss of adherence is likely to be lower, but information is lacking on
      that subject. We will partially address this question by following patients up to 2 years.
      Longer rates of adherence need to be ascertained, but this represents an objective that is
      not part of the current proposal.

      Why setting these objectives at 60% of long-term adherence to treatment?

      Our objective to treat 60% of the patients may appear quite low. However, it is significantly
      higher than the appalling 20-30% rate of initiation of treatment currently seen in the
      province of Quebec and in Canada in general, combined with the 30-50% long-term adherence
      observed in practice (translating currently into 5-20% of patients taking appropriate
      long-term treatment for osteoporosis). If we are successful, the rate of treatment will be
      increased by 3 to 10 times.

      On the contrary, our objective to treat 60% of the patients may appear unrealistic. To attain
      this goal, we have to include all health practitioners involved in patients' care (e.g.,
      family physician, orthopedist, pharmacist, and the patients themselves), as well as testing
      additional safety nets to ensure adherence, including patients' recall by the nurse
      coordinator, estimating the impact of adding the results of serum markers of bone metabolism,
      and allowing problematic patients (i.e. patients with hip fracture, those without family
      physicians, those with complex medical situations, and those who do not adhere despite all
      other measures) the possibility to obtain a consultation with a bone specialist.

      Effect on fracture rates If our objective to treat 60% of the patients is attained, it is
      likely to translate into a significant reduction of close to 50% of vertebral fractures (a
      decrease of 80-90% of the risk of recurrent vertebral fracture by bisphosphonates in 60% of
      the population) and of close to 30% of non-vertebral fractures, including the hip (reduction
      of 50% of the risk by bisphosphonate use in 60% of the population). These fractures are
      associated with morbidity (chronic pain, invalidity) and increased mortality, and contribute
      to increase the costs to the public Health Care System (hospitalization, surgery,
      rehabilitation, short-, mid- and long-term care in nursing homes needed). However, this
      impact on fractures will only become evaluable through access to Quebec's Health Insurance
      Agency (RAMQ) databases (through the regional Health Agency), by comparing the rate of new
      fracture for patients compliant to the intervention relative to the patients who will refuse
      to give their informed consent to be included into the intervention (estimated to 10-15% of
      the patients with fractures) and to the patients who will not be compliant (estimated to 40%
      of the patients who will give their consent to participate). In addition, this effect on
      fracture rates will only become significant after a longer period (3-5 years) of observation.
    

Intervention name(s): Control group; Minimal Intervention; Intensive Intervention
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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; 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.; 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)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Osteoporosis; Fragility fractures; Fracture clinics; Orthopedic surgeons