Education for Osteoporosis in Persons With Existing Fractures

December 17, 2007 updated by: University of Adelaide

Osteoporosis Education Clinic Study

We wish to investigate whether a weekly, 2½ hour group-based osteoporosis education intervention (the Osteoporosis Prevention and Self-Management Course), is different to one session course (1x 2½ hours) on osteoporosis knowledge, confidence to eat calcium-containing foods, confidence to exercise, and amount of exercise undertaken after three and nine months of follow-up in people aged over 50 years who have already had a bone fracture.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Instruments used to determine change after 3 and 9 months:

Osteoporosis knowledge: Osteoporosis Knowledge Assessment Test (Winzenberg et al. BMC Musculoskelet Disord 2003) Calcium intake: Food frequency questionnaire (Angus et al. J Am Diet Assoc 1989) Calcium and exercise self-efficacy: Osteoporosis Self-Efficacy Scale (Horan et al Res Nurs Health 1998) Physical activity: CHAMPS II (Stewart et al. J Gerontol A Biol Sci Med Sci 2001)

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5092
        • Modbury Hospital, Modbury

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presented to Modbury Hospital's Accident and Emergency Department with a new bone fracture

Exclusion Criteria:

  • Residence in nursing home
  • Fracture sustained in motor bike, push bike or motor vehicle accident
  • Fracture sustained due to high trauma, such as fall from roof or ladder
  • Dementia
  • Inability to participate in group settings
  • Inability to understand spoken English
  • Inability to provide informed consent
  • Pathological fracture
  • Usual place of residence outside South Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Osteoporosis Prevention and Self-Management Course (4 x 2 1/2 hours)
Behavioral: Osteoporosis Prevention and Self-Management Course
Four weekly education sessions of 2 1/2 hours duration, in a group session facilitated by a community nurse and trained lay leader.
Active Comparator: 2
One "introductory" osteoporosis education session (1 x 2 1/2 hours)
Behavioral: Introductory education session on osteoporosis
Introductory education session, 1 x 2 1/2 hours in a group session facilitated by a community nurse and trained lay person.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference between groups at three months on osteoporosis knowledge, confidence in ability to consume calcium and to exercise, actual calcium consumption and exercise levels
Time Frame: Three and nine months
Three and nine months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes between baseline and three months within each group on osteoporosis knowledge, confidence in the ability to each calcium-containing foods and exercise, and the amount of calcium consumed in foods and exercise undertaken
Time Frame: Three and nine months
Three and nine months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Adelaide

Collaborators

Osteoporosis SA

Investigators

  • Principal Investigator: Laura L Laslett, MMedSci, University of Adelaide
  • Study Chair: Julian D McNeil, PhD FRACP, University of Adelaide

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

December 18, 2007

Last Update Submitted That Met QC Criteria

December 17, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.180405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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