The Effectiveness of Individualised Bone Density Feedback and Osteoporosis Education in Premenopausal Women

Osteoporosis Clinical Trial

Official title:

The Effect on Behavior and Bone Mineral Density of Individualized Bone Mineral Density Feedback and Educational Interventions in Premenopausal Women: a Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273260
• Other study ID #: MRI-001
• Status: Completed
• Phase: Phase 2
• First received: January 5, 2006
• Last updated: May 8, 2006
• Start date: January 2000
• Est. completion date: December 2002

Study information

• Verified date: January 2006
• Source: Menzies Institute for Medical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether giving women feedback concerning their bone mineral density, combined with either an information leaflet or group education concerning osteoporosis changes women's behavior and/or bone density.

Description:

Fractures due to osteoporosis are a major public health problem. Bone density is one of the major predictors of these osteoporotic fractures and is the result of the amount of bone gained in early life (i.e peak bone mass) and subsequent bone loss. Cigarette smoking, physical inactivity and inadequate calcium intake are widely regarded as risk factors for osteoporosis (as well as for other common diseases for the former two). Despite this information being widely available and actively promoted, the prevalence of these risk factors in the population remains unacceptably high. In women (mean age 33) taking part in a study of the determinants of bone mass in children, we recently reported substantial change in these behaviours at 12 months follow-up when women received an information leaflet and individualised bone density feedback. These women were highly selected and it is unclear if this response is representative of all women. With this study, we aim to test whether individualised bone density feedback, combined with either an information leaflet or small group education will change women's osteporosis preventive behaviors and/or bone density.

Specifically, we aimed to test the following hypotheses:

1. Women are more likely to change calcium intake and physical activity if their BMD is low.

2. Group education (in the form of the Osteoporosis Prevention and Self Management course) will be more efficacious at changing these lifestyle behaviours than an information leaflet alone.

3. Bone density feedback and educational intervention have independent effects on behavior and BMD change.

4. Women who improve their physical activity or dietary calcium intake will have a change in bone mass over 2 years that is 0.34-0.54% per annum better (depending on site and lifestyle factor) than those who do not alter their behaviour.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 44 Years

Eligibility

Inclusion Criteria:

• women aged between 25 and 44 years of age

Exclusion Criteria:

• previous had measurement of bone densitometry

• thyroid disease

• renal failure

• malignancy

• rheumatoid arthritis

• history of hysterectomy

• hormone replacement therapy

• were pregnant or planning pregnancy within 2 years of study entry

• lactating.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Behavioral:
• individualised bone density feedback and education

Locations

Country	Name	City	State
Australia	Menzies Research Institute	Hobart	Tasmania

Sponsors (1)

Lead Sponsor	Collaborator
Menzies Institute for Medical Research

Country where clinical trial is conducted

Australia, 

References & Publications (5)

Winzenberg T, Oldenburg B, Frendin S, De Wit L, Riley M, Jones G. The effect on behavior and bone mineral density of individualized bone mineral density feedback and educational interventions in premenopausal women: a randomized controlled trial [NCT00273 — View Citation

Winzenberg TM, Oldenburg B, Frendin S, De Wit L, Jones G. A mother-based intervention trial for osteoporosis prevention in children. Prev Med. 2006 Jan;42(1):21-6. Epub 2005 Dec 5. — View Citation

Winzenberg TM, Oldenburg B, Frendin S, De Wit L, Jones G. Effects of bone density feedback and group education on osteoporosis knowledge and osteoporosis self-efficacy in premenopausal women: a randomized controlled trial. J Clin Densitom. 2005 Spring;8(1 — View Citation

Winzenberg TM, Oldenburg B, Frendin S, Jones G. The design of a valid and reliable questionnaire to measure osteoporosis knowledge in women: the Osteoporosis Knowledge Assessment Tool (OKAT). BMC Musculoskelet Disord. 2003 Jul 24;4:17. — View Citation

Winzenberg TM, Riley M, Frendin S, Oldenburg B, Jones G. Sociodemographic factors associated with calcium intake in premenopausal women: a cross-sectional study. Eur J Clin Nutr. 2005 Mar;59(3):463-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density
Secondary	physical activity
Secondary	dietary calcium intake
Secondary	calcium supplement use
Secondary	smoking status