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Completed

NCT Number: NCT00643331

The Effect of Exercise in Postmenopausal Women with Low Bone Density

This clinical trial aims to evaluate the effects of a 12 month gym- and home-based exercise program on bone density and falls risk factors in postmenopausal women with low bone density. It is hypothesised that the exercise program will lead to improvements in bone density and falls risk factors such as balance and muscle strength compared with usual care.

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Melbourne

Melbourne, Victoria, 3010, Australia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Be aged greater than 50 years
  • Be at least 5 years post menopause (defined as the last normal menstrual bleed)
  • Have osteopenia of the hip defined as a DXA T-score between -1 and -2.5 in one or more regions of the proximal femur (total hip, neck or trochanter regions).
  • Have primary osteopenia
  • Be community dwelling (not in residential care)
  • Be able to attend an exercise program 3 times per week over the 12-month period
  • Be able to read and write English

Exclusion criteria

  • Secondary causes of bone loss such as osteomalacia, glucocorticoid medication
  • Co-morbidities that would interfere with participation in exercise such as severe heart or pulmonary disease, inflammatory joint disease, severe osteoarthritis, psychiatric condition
  • Physical or orthopaedic disabilities that would place the subject at risk or limit their ability to perform exercise
  • Spinal osteoporosis defined as DXA T-score <-2.5
  • A past vertebral fracture
  • Body mass index > 35 or < 18.
  • Currently on hormone replacement therapy (HRT)
  • Current smoker
  • Past use of HRT within the past 3 years and for more than 6 months duration
  • Taking medication known to affect bone including oestrogen or steroid hormones
  • Known clinically significant liver or renal disease
  • Cancer within the past 5 years
  • Doing regular strength training and/or weight-bearing exercise at least once per week in past 6 months
  • Unlikely to comply with the intervention protocol

Treatment and study plan

Exercise

Behavioral

Exercise performed at gym and at home comprising strength, balance and impact exercise

Primary outcomes

  1. Bone density measured using DXA at the lumbar spine and proximal femur

    Time frame: 12 months

Secondary outcomes

  1. Falls risk factors

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Melbourne

Other

Collaborators

  • Swisse Vitamins Pty Ltd

Registry information

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Mar 26, 2008
Registry last updated
Dec 9, 2024

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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