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

This study has been completed.
Sponsor:
Information provided by:
Menzies Research Institute Tasmania
ClinicalTrials.gov Identifier:
NCT00273260
First received: January 5, 2006
Last updated: May 8, 2006
Last verified: January 2006
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Behavioral: individualised bone density feedback and education
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Menzies Research Institute Tasmania:

Primary Outcome Measures:
  • Bone mineral density

Secondary Outcome Measures:
  • physical activity
  • dietary calcium intake
  • calcium supplement use
  • smoking status

Estimated Enrollment: 400
Study Start Date: January 2000
Estimated Study Completion Date: December 2002
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.
  Eligibility

Ages Eligible for Study:   25 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00273260

Locations
Australia, Tasmania
Menzies Research Institute
Hobart, Tasmania, Australia, 7000
Sponsors and Collaborators
Menzies Research Institute Tasmania
Investigators
Principal Investigator: Graeme Jones, MD Menzies Research Institute Tasmania
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00273260     History of Changes
Other Study ID Numbers: MRI-001
Study First Received: January 5, 2006
Last Updated: May 8, 2006
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 22, 2014