Status:
COMPLETED
The Effect of Exercise in Postmenopausal Women with Low Bone Density
Lead Sponsor:
University of Melbourne
Collaborating Sponsors:
Swisse Vitamins Pty Ltd
Conditions:
Osteoporosis
Osteopenia
Eligibility:
FEMALE
50+ years
Phase:
PHASE2
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 hypothes...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00643331
Start Date
February 1 2001
End Date
November 1 2007
Last Update
December 9 2024
Active Locations (1)
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1
University of Melbourne
Melbourne, Victoria, Australia, 3010