Strategies to Treat Osteoporosis Following a Fragility Fracture

NCT00512499 | Completed DMC

• 1 other identifier: 06-091
• Study Type: interventional
• Target: 1,410
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Osteoporosis; Fragility fractures; Fracture clinics; Orthopedic surgeons

Outcome Measures

Primary Outcomes (1)

• Percentage of patients pursuing an effective osteoporosis treatment

  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

  At one year after the clinical fracture

Secondary Outcomes (1)

• Rate of recurrent fragility fractures according to the site of the inclusion fracture

  Up to 4 years after clinical fracture

Study Arms (3)

Group 1

PLACEBO COMPARATOR

CONTROL GROUP (first year only; maximum 300 patients): patients seen by CHUS orthopedists at the Hotel-Dieu site, where no nurse coordinator is available for inclusion. This is random but not randomized.

Behavioral: Control group

Group 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

Group 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

Interventions

Control group BEHAVIORAL

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

Group 1

Minimal Intervention BEHAVIORAL

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.

Group 2

Intensive Intervention BEHAVIORAL

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)

Group 3

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• No Primary Care Practitioner
• Severe co-morbidity requiring specialized care
• Failure to consent

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Merck Sharp & Dohme LLC: collaborator
• Procter and Gamble: collaborator
• Sanofi: collaborator
• Novartis: collaborator
• Amgen: collaborator
• Eli Lilly and Company: collaborator
• Servier: collaborator
• Warner Chilcott: collaborator

Study Sites (1)

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (6)

• Bissonnette L, April PM, Dumais R, Boire G, Roux S. Atypical fracture of the tibial diaphysis associated with bisphosphonate therapy: a case report. Bone. 2013 Oct;56(2):406-9. doi: 10.1016/j.bone.2013.07.012. Epub 2013 Jul 17.

  PMID: 23871749 BACKGROUND

• Gaboury I, Corriveau H, Boire G, Cabana F, Beaulieu MC, Dagenais P, Gosselin S, Bogoch E, Rochette M, Filiatrault J, Laforest S, Jean S, Fansi A, Theriault D, Burnand B. Partnership for fragility bone fracture care provision and prevention program (P4Bones): study protocol for a secondary fracture prevention pragmatic controlled trial. Implement Sci. 2013 Jan 24;8:10. doi: 10.1186/1748-5908-8-10.

  PMID: 23343392 BACKGROUND

• Roux S, Cabana F, Carrier N, Beaulieu M, April PM, Beaulieu MC, Boire G. The World Health Organization Fracture Risk Assessment Tool (FRAX) underestimates incident and recurrent fractures in consecutive patients with fragility fractures. J Clin Endocrinol Metab. 2014 Jul;99(7):2400-8. doi: 10.1210/jc.2013-4507. Epub 2014 Apr 29.

  PMID: 24780062 RESULT

• Roux S, Beaulieu M, Beaulieu MC, Cabana F, Boire G. Priming primary care physicians to treat osteoporosis after a fragility fracture: an integrated multidisciplinary approach. J Rheumatol. 2013 May;40(5):703-11. doi: 10.3899/jrheum.120908. Epub 2013 Mar 15.

  PMID: 23504379 RESULT

• Sale JE, Jain R, Akilan K, Senior K, Beaton D, Bogoch E, Boire G, Beaulieu MC, Lightfoot D, Funnell L. What Do We Know about Individuals Who Are Assessed as Being at Moderate Risk for Future Fracture in Canada? Health (Irvine Calif). 2015 May;7(5):514-520. doi: 10.4236/health.2015.75061.

  PMID: 26523214 RESULT

• Roux S, Gaboury I, Gionet-Landry N, Garant MP, Beaulieu MC, Carrier N, Cabana F, Boire G. Using a sequential explanatory mixed method to evaluate the therapeutic window of opportunity for initiating osteoporosis treatment following fragility fractures. Osteoporos Int. 2018 Apr;29(4):961-971. doi: 10.1007/s00198-017-4374-8. Epub 2018 Feb 14.

  PMID: 29445831 DERIVED

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Gilles Boire, MD MSc

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

• François Cabana, MD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 3, 2007
• First Posted: August 7, 2007
• Study Start: February 1, 2007
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2016
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

CA (1)