Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
BEHAVIORAL - Exercise

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

No intervention: 2 - Usual care no additional exercise


BEHAVIORAL: Exercise
Exercise performed at gym and at home comprising strength, balance and impact exercise
Intervention code [1] 0 0
BEHAVIORAL
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00643331