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Completed

NCT Number: NCT00273260

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

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.

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Key information

Age range

25 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Menzies Research Institute

Hobart, Tasmania, 7000, Australia

About this study

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:

  • Women are more likely to change calcium intake and physical activity if their BMD is low.
  • 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.
  • Bone density feedback and educational intervention have independent effects on behavior and BMD change.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

individualised bone density feedback and education

Behavioral

Primary outcomes

  1. Bone mineral density

Secondary outcomes

  1. physical activity

  2. dietary calcium intake

  3. calcium supplement use

  4. smoking status

Sponsors and collaborators

Lead sponsor

Menzies Institute for Medical Research

Other

Registry information

Official study 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.

Important dates

Study start
2000
Study completion
2002
First posted
Jan 9, 2006
Registry last updated
May 9, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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