NCT00152321

Brief Summary

An evidence-based quality improvement intervention will overcome multiple barriers to best practice and improve rates of diagnosis and effective treatment for osteoporosis in high-risk patients. The intervention will be directed at patients (education and counseling) and their primary care physicians (reminders and opinion leader generated and endorsed single page guidelines)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2003

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

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

2.5 years

First QC Date

September 7, 2005

Last Update Submit

July 25, 2015

Conditions

OsteoporosisFractures

Keywords

osteoporosiswrist fracturesquality improvementknowledge translation

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients starting bisphosphonate treatment within 6 months of fracture

    6 months

Secondary Outcomes (5)

  • Appropriate care (BMD test performed and treatment if low bone mass)

    6 months

  • Bone mineral density testing

    6 months

  • Self reported diagnosis of osteoporosis and other knowledge

    6 months

  • Satisfaction with care

    6 months

  • Health related quality of life

    6 months

Study Arms (2)

A

EXPERIMENTAL

Multifaceted intervention

Behavioral: Patients (education, counseling) and Physicians (reminders,1-page guidelines).Behavioral: Multifaceted intervention

B

ACTIVE COMPARATOR

Usual Care

Other: Usual Care

Interventions

Patients (education, counseling) and Physicians (reminders,1-page guidelines).BEHAVIORAL
A
Multifaceted interventionBEHAVIORAL

Educational materials, counseling, opinion leader based guidelines, reminders

A
Usual CareOTHER
B

Eligibility Criteria

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

You may qualify if:

  • All patients 50 years of age or older with a wrist fracture who present to the Emergency Departments or Fracture Clinics at our two study sites will be eligible for study enrollment. Specifically:
  • Age 50 years or greater,
  • Any distal forearm fracture

You may not qualify if:

  • Unable to give simple informed consent,
  • Unwilling to participate in the study,
  • Unable to understand, read, or converse in English,
  • Place of residence outside Capital Health or longterm care facility,
  • Already receiving osteoporosis treatment with a bisphosphonate,
  • Previously documented allergy or intolerance to a bisphosphonate,
  • Currently enrolled in the pilot study or other osteoporosis study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (3)

  • Majumdar SR, Johnson JA, McAlister FA, Bellerose D, Russell AS, Hanley DA, Morrish DW, Maksymowych WP, Rowe BH. Multifaceted intervention to improve diagnosis and treatment of osteoporosis in patients with recent wrist fracture: a randomized controlled trial. CMAJ. 2008 Feb 26;178(5):569-75. doi: 10.1503/cmaj.070981.

    PMID: 18299546RESULT

  • Majumdar SR, Lier DA, Rowe BH, Russell AS, McAlister FA, Maksymowych WP, Hanley DA, Morrish DW, Johnson JA. Cost-effectiveness of a multifaceted intervention to improve quality of osteoporosis care after wrist fracture. Osteoporos Int. 2011 Jun;22(6):1799-808. doi: 10.1007/s00198-010-1412-1. Epub 2010 Sep 29.

    PMID: 20878389RESULT

  • Majumdar SR, Johnson JA, Bellerose D, McAlister FA, Russell AS, Hanley DA, Garg S, Lier DA, Maksymowych WP, Morrish DW, Rowe BH. Nurse case-manager vs multifaceted intervention to improve quality of osteoporosis care after wrist fracture: randomized controlled pilot study. Osteoporos Int. 2011 Jan;22(1):223-30. doi: 10.1007/s00198-010-1212-7. Epub 2010 Apr 1.

    PMID: 20358359DERIVED

MeSH Terms

Conditions

OsteoporosisFractures, BoneWrist Fractures

Interventions

Educational StatusCounselingPhysicians

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWounds and InjuriesWrist InjuriesArm Injuries

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Personnel

Study Officials

  • Sumit R Majumdar, MD, MPH

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 9, 2005

Study Start

September 1, 2003

Primary Completion

March 1, 2006

Study Completion

March 1, 2010

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

CA(1)