NCT00575250

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2004

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, 2004

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
Last Updated

December 18, 2007

Status Verified

December 1, 2007

First QC Date

December 17, 2007

Last Update Submit

December 17, 2007

Conditions

Keywords

Osteoporosis/prevention & controlOsteoporosis Prevention and Self-Management CoursePatient Education/*trends//QuestionnairesAdult//Aged//Middle AgedLife Style//

Outcome Measures

Primary Outcomes (1)

  • Difference between groups at three months on osteoporosis knowledge, confidence in ability to consume calcium and to exercise, actual calcium consumption and exercise levels

    Three and nine months

Secondary Outcomes (1)

  • 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

    Three and nine months

Study Arms (2)

1

ACTIVE COMPARATOR

Osteoporosis Prevention and Self-Management Course (4 x 2 1/2 hours)

Behavioral: Osteoporosis Prevention and Self-Management Course

2

ACTIVE COMPARATOR

One "introductory" osteoporosis education session (1 x 2 1/2 hours)

Behavioral: Introductory education session on osteoporosis

Interventions

Four weekly education sessions of 2 1/2 hours duration, in a group session facilitated by a community nurse and trained lay leader.

1

Introductory education session, 1 x 2 1/2 hours in a group session facilitated by a community nurse and trained lay person.

2

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Modbury Hospital, Modbury

Adelaide, South Australia, 5092, Australia

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Laura L Laslett, MMedSci

    University of Adelaide

    PRINCIPAL INVESTIGATOR
  • Julian D McNeil, PhD FRACP

    University of Adelaide

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 18, 2007

Study Start

January 1, 2004

Study Completion

December 1, 2007

Last Updated

December 18, 2007

Record last verified: 2007-12

Locations