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

May 8, 2006 updated by: Menzies Institute for Medical Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment

400

Phase

  • Phase 2

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
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Menzies Research Institute

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

25 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bone mineral density

Secondary Outcome Measures

Outcome Measure
physical activity
dietary calcium intake
calcium supplement use
smoking status

Collaborators and Investigators

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

Sponsor

Menzies Institute for Medical Research

Investigators

  • Principal Investigator: Graeme Jones, MD, Menzies Institute for Medical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2000

Study Completion

December 1, 2002

Study Registration Dates

First Submitted

January 5, 2006

First Submitted That Met QC Criteria

January 5, 2006

First Posted (Estimate)

January 9, 2006

Study Record Updates

Last Update Posted (Estimate)

May 9, 2006

Last Update Submitted That Met QC Criteria

May 8, 2006

Last Verified

January 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRI-001

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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