Osteopenia, Osteoporosis
Conditions
Keywords
Osteoporosis, Exercise, Low bone density, Falls
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.
Interventions
BEHAVIORALExercise
Exercise performed at gym and at home comprising strength, balance and impact exercise
Sponsors
Swisse Vitamins Pty Ltd
University of Melbourne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
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 \< 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone density measured using DXA at the lumbar spine and proximal femur | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Falls risk factors | 12 months |
Countries
Australia
Outcome results
None listed