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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00643331




Registration number
NCT00643331
Ethics application status
Date submitted
24/03/2008
Date registered
26/03/2008
Date last updated
3/06/2015

Titles & IDs
Public title
The Effect of Exercise in Postmenopausal Women With Low Bone Density
Scientific title
The Effect of Exercise in Postmenopausal Women With Low Bone Density
Secondary ID [1] 0 0
2001.075
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 0 0
Osteopenia 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Exercise

Experimental: 1 - Exercise performed at the gym and at home

No Intervention: 2 - Usual care no additional exercise


Behaviour: Exercise
Exercise performed at gym and at home comprising strength, balance and impact exercise
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Bone density measured using DXA at the lumbar spine and proximal femur
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Falls risk factors
Timepoint [1] 0 0
12 months

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2007
Sample size
Target
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Swisse Vitamins Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00643331
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kim L Bennell, PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00643331