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Clinical Trials/NCT00643331
NCT00643331
Completed
Phase 2

The Effect of Exercise in Postmenopausal Women with Low Bone Density

University of Melbourne1 site in 1 country38 target enrollmentFebruary 2001

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Osteoporosis
Sponsor
University of Melbourne
Enrollment
38
Locations
1
Primary Endpoint
Bone density measured using DXA at the lumbar spine and proximal femur
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2001
End Date
November 2007
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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 \<
  • 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

Outcomes

Primary Outcomes

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

Time Frame: 12 months

Secondary Outcomes

  • Falls risk factors(12 months)

Study Sites (1)

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