NCT00643331CompletedPhase 2
The Effect of Exercise in Postmenopausal Women with Low Bone Density
University of Melbourne1 site in 1 country38 target enrollmentStarted: February 1, 2001Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Melbourne
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Bone density measured using DXA at the lumbar spine and proximal femur
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
1
Experimental
Exercise performed at the gym and at home
Intervention: Exercise (Behavioral)
2
No Intervention
Usual care no additional exercise
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)
Investigators
Study Sites (1)
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