NCT00175214

Brief Summary

The primary objective of this proposed research is to improve the quality of care for patients who present to the Emergency Department with osteoporosis and a fracture of the wrist, by increasing the use of proven efficacious osteoporosis treatment. This is the primary study outcome, and it is defined as starting any one of hormone therapy, a bisphosphonate, raloxifene, or calcitonin within 6 months of a fracture of the wrist. The study hypothesis is that a quality improvement intervention (with multiple components that include a notification system for primary care physicians, patient-specific reminders, locally generated treatment guidelines endorsed by opinion leaders, and patient education and counseling) will lead to increased use of proven efficacious osteoporosis treatments in patients eligible for secondary prevention. This hypothesis will be tested by comparing the intervention with usual care controls, in a prospective nonrandomized controlled trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

September 15, 2005

Status Verified

September 1, 2005

First QC Date

September 10, 2005

Last Update Submit

September 10, 2005

Conditions

OsteoporosisWrist Fractures

Keywords

osteoporosiswrist fracturesquality improvementknowledge translation

Outcome Measures

Primary Outcomes (1)

  • Increased use of proven efficacious osteoporosis treatment within six months of study enrollment, defined as: hormone therapy, a bisphosphonate, raloxifene, or calcitonin.

Secondary Outcomes (8)

  • 1. BMD testing

  • 2. Osteoporosis diagnosis

  • 3. Osteoporosis related knowledge

  • 4. Satisfaction

  • 5. Generic, Disease Specific, and Function-related QOL

  • +3 more secondary outcomes

Interventions

Multifaceted intervention (patient education, physician guidelines, reminders)BEHAVIORAL

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 50 years
  • any closed distal forearm fracture
  • discharged home

You may not qualify if:

  • unwilling or unable to provide consent
  • admitted to hospital
  • long term care resident
  • residence outside Edmonton, Alberta
  • unable to read and converse in English
  • currently taking prescription osteoporosis treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospitals

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (2)

  • Majumdar SR, Rowe BH, Folk D, Johnson JA, Holroyd BH, Morrish DW, Maksymowych WP, Steiner IP, Harley CH, Wirzba BJ, Hanley DA, Blitz S, Russell AS. A controlled trial to increase detection and treatment of osteoporosis in older patients with a wrist fracture. Ann Intern Med. 2004 Sep 7;141(5):366-73. doi: 10.7326/0003-4819-141-5-200409070-00011.

    PMID: 15353428RESULT

  • Majumdar SR, Johnson JA, Lier DA, Russell AS, Hanley DA, Blitz S, Steiner IP, Maksymowych WP, Morrish DW, Holroyd BR, Rowe BH. Persistence, reproducibility, and cost-effectiveness of an intervention to improve the quality of osteoporosis care after a fracture of the wrist: results of a controlled trial. Osteoporos Int. 2007 Mar;18(3):261-70. doi: 10.1007/s00198-006-0248-1. Epub 2006 Nov 4.

    PMID: 17086470DERIVED

MeSH Terms

Conditions

OsteoporosisWrist Fractures

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Sumit R Majumdar, MD, MPH

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 15, 2005

Study Start

January 1, 2001

Study Completion

January 1, 2005

Last Updated

September 15, 2005

Record last verified: 2005-09

Locations

CA(1)