Recruiting

Observational Study

Sponsor:

Ontario Ministry of Health and Long Term Care

Code:

NCT00511693

Conditions

Osteoporosis

Fragility Fractures

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

centralized osteoporosis coordinator

fall prevention

Study Details

Brief summary:

A Regional Osteoporosis Coordinator located at Women's College Hospital will follow-up with low trauma fracture patients from 30 smaller community hospitals across Ontario. To evaluate whether this quality improvement program can increase post-fracture osteoporosis care in these individuals, hospitals will be randomized to receive osteoporosis specific recommendations or falls prevention advice. Patients will be asked to complete two short telephone surveys about their recent fracture, risk factors, osteoporosis knowledge and diagnostic and treatment history. All patients in the falls prevention advice group will receive the osteoporosis specific recommendations 6 months after their fracture.

Conditions

Osteoporosis

Fragility Fractures

Study ID

NCT00511693

Start date

Jun, 2007

Status verified date

Jul, 2007

Completion date

Dec, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Cluster site (hospital) level: Hospitals with no dedicated osteoporosis coordinator that treat more than 60 patients/year in their Emergency Department and who have a Telehealth studio.
2. Patient level: Patients 40 years old and over (men and women) presenting with a low trauma fracture of the hip, forearm and wrist, rib(s), sternum, thoracic and lumbar spine, shoulder and upper arm, pelvis, lower leg and ankle. Subjects without previous medication as well as subjects on osteoporosis medication and presenting with a fracture will be included.

Exclusion Criteria:

1. Hospitals that have an Osteoporosis Strategy fracture clinic coordinator
2. Fractures associated with major trauma; fractures due to malignancy

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: 1

hospitals randomly allocated to receive physician and patient osteoporosis recommendations from the regional coordinator

active comparator: 2

hospitals randomly allocated to receive falls prevention advice

Interventions

centralized osteoporosis coordinator

The regional osteoporosis coordinator will phone fracture patients and counsel them about their risk of osteoporosis, reiterating messages in the print material. The coordinator will also follow-up with family physicians by phone and send them a patient-specific reminder that informs them that their patient has experienced a fracture and they are at high risk for future fracture. As part of the reminder, a set of evidence-based recommendations about appropriate BMD testing and treatment based on the recent Canadian guidelines will be included. If the patient does not have a family physician, the regional osteoporosis coordinator will facilitate referral to the MOP.

fall prevention

Fracture patients from hospitals receiving falls prevention advice will also be called by the osteoporosis regional coordinator. The patient will receive educational material and telephone counseling regarding fall prevention. During the call, patients will be encouraged to visit their family physician for fracture follow-up. They will not receive counseling or educational materials about osteoporosis at this time. Patients in the falls prevention group will receive the physician and patient osteoporosis program six months post-fracture.

Primary outcome measure

  • proportion of patients from the intervention group as compared to the control group that had "appropriate management" based on a composite of undergoing a BMD test and starting therapy within 6 months of fracture. [ Time Frame: 1.5 years ]

Central Contacts and Locations

Central contacts

Oana S Donescu, MD PhD

416 597-3422Donescu.Smaranda@TorontoRehab.on.ca

Susan B Jaglal, PhD

416 978-0315susan.jaglal@utoronto.ca

Locations

Toronto Rehabilitation Institute

Recruiting

Toronto, Ontario, Canada, M5G 2A2

Contacts

Oana S Donescu, MD PhD

416 597-3422Donescu.Smaranda@TorontoRehab.on.ca

Susan B Jaglal, PhD

416 978 0315susan.jaglal@utoronto.ca

More Information

Sponsor

Ontario Ministry of Health and Long Term Care

Last update posted

Aug 7, 2007

Last verified

Jul, 2007

Keywords

  • fragility fracture
  • management of osteoporosis
  • osteoporosis coordinator
  • small volume hospitals

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ontario Ministry of Health and Long Term Care on 2007-08-07.