Education for Osteoporosis in Persons With Existing Fractures

Osteoporosis Clinical Trial

Official title:

Osteoporosis Education Clinic Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575250
• Other study ID #: 2.180405
• Status: Completed
• Phase: N/A
• First received: December 17, 2007
• Last updated: December 17, 2007
• Start date: January 2004
• Est. completion date: December 2007

Study information

• Verified date: December 2007
• Source: University of Adelaide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	Modbury Hospital, Modbury	Adelaide	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
University of Adelaide	Osteoporosis SA

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No