Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000220369
Ethics application status
Approved
Date submitted
21/04/2008
Date registered
24/04/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise to prevent osteoporosis in breast cancer survivors.
Scientific title
Exercise to prevent osteoporosis as a consequence of hormone treatment in post menopausal women treated for breast cancer
Secondary ID [1] 553 0
NHMRC Application No: 512555
Universal Trial Number (UTN)
Trial acronym
BONES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 3081 0
Breast Cancer 3082 0
Condition category
Condition code
Musculoskeletal 3210 3210 0 0
Osteoporosis
Cancer 3249 3249 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise programme - exercise training will run for 12 months, 3 x per week for approx 1 hr each session. A trainer will meet women at their local community gym 3 x per week for the first 4 weeks then reducing to once a month for the rest of the year. The program will consist of 5 min warm-up, 25 min high impact exercise using steps (jumping, running, hopping)25 mins resistance exercise in the limbs and trunk using free weights and resistance equipment, and 5 min cool down. * Daily Calcium carbonate (1200mg) and vitamin D (1000 IU) supplements
Intervention code [1] 2832 0
Prevention
Comparator / control treatment
Daily Calcium Carbonate (1200mg) and Vitamin D (1000 IU) supplements No exercise prescription
Control group
Active

Outcomes
Primary outcome [1] 4122 0
Bone Mineral Density: DEXA scans of spine and hip
Timepoint [1] 4122 0
baseline, 6 months, 12 months
Secondary outcome [1] 6895 0
Biochemical markers of bone remodelling (bone formation and resorption): automated imunoassay
Timepoint [1] 6895 0
baseline, 6 months, 12 months
Secondary outcome [2] 6923 0
Self report outcomes: quality of life questionnaire and medical outcomes survey short forms
Timepoint [2] 6923 0
baseline, 6 months, 12 months
Secondary outcome [3] 6937 0
Lymphoedema status: Bioimpedance spectroscopy
Timepoint [3] 6937 0
baseline, 6 months, 12 months
Secondary outcome [4] 6939 0
Bone Mineral Density (BMD): DEXA scans of trochanteric, femoral neck and spinal BMD
Timepoint [4] 6939 0
baseline, 6 months, 12 months

Eligibility
Key inclusion criteria
Women will be included if they : Are postmenopausal, based on age, menses history, and/or surgery. Have stage I-III breast cancer. Have oestrogen receptor and/or progesterone receptor positive breast cancer. Have commenced taking aromatase inhibitor within 10 weeks. Have Eastern Collaborative Oncology Group performance status <=2 (Oken et al, 1982). Are sedentary.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women will be excluded if they have:
Any clinical or radiological evidence of distant spread of disease.
Taken any HRT within the past 12 months.
Taken bisphosphonates within the past 6 months.
Received prior treatment with continuous systemic glucocorticoids within the past 6 months.
Current treatments with any drugs known to affect the skeleton (eg Calcitonin, calcitrol, mithramycin or gallium nitrate).
A history of diseases that influence bone metabolism, such as Paget's disease or ongoing thyroid toxicosis.
Previous or concomitant malignancy (apart from breast cancer) within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Particpants will be recruited from Royal Prince Alfred, Concord General Repatriation, Strathfield Private, and Westmead Hospitals.
A person not involved with the project will prepare sequentially numbered opaque envelopes with the group allocation sealed inside.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Immediately after baseline assessment, women will be randomly allocated by the research assistant to either the Exercise or the control group. The randomisation list will be computer generated in permuted blocks and stratified by whether the woman has previously used Tamoxifen. The randomisation process should distribute equally to the two groups the women receiving other therapies (eg, chemotherapy, radiotherapy), and other aspects of breast cancer management.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 3333 0
Government body
Name [1] 3333 0
Cancer Australia
Country [1] 3333 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Faculty of Health Sciences
75 East St (PO Box 170)
Lidcombe 1825
Country
Australia
Secondary sponsor category [1] 2979 0
None
Name [1] 2979 0
Address [1] 2979 0
Country [1] 2979 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5345 0
University of Sydney Ethics Committee
Ethics committee address [1] 5345 0
Level 3, Room 313
A22- Old Teacher's College
University of Sydney
Camperdown, 2006
Ethics committee country [1] 5345 0
Australia
Date submitted for ethics approval [1] 5345 0
Approval date [1] 5345 0
27/10/2006
Ethics approval number [1] 5345 0
10-2006/9441
Ethics committee name [2] 5346 0
Royal North Shore Hospital Ethics Committee
Ethics committee address [2] 5346 0
Research Office
Level 4, Vindin House
Royal North Shore Hospital
Pacific Hwy, St Leonards NSW 2065
Ethics committee country [2] 5346 0
Australia
Date submitted for ethics approval [2] 5346 0
Approval date [2] 5346 0
22/11/2006
Ethics approval number [2] 5346 0
0609-153M

Summary
Brief summary
Breast cancer affects 1 in 11 women. Aromatase inhibitors, a first-line treatment for the postmenopausal women treated for breast cancer, have improved the prognosis of breast cancer by at least 20%. However, one side-effect is a rapid decrease in bone mineral density. Without an effective intervention to address the osteoporosis, health costs will increase significantly. The aim of the proposed study is to determine whether the decline in BMD induced by use of
aromatase inhibitors for treatment of breast cancer can be reversed in postmenopausal women.
We will undertake a randomized controlled trial to determine whether high impact exercise prevents loss of bone mineral density more effectively than usual care. Participants in both groups will
receive vitamin D and calcium supplements.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28531 0
Address 28531 0
Country 28531 0
Phone 28531 0
Fax 28531 0
Email 28531 0
Contact person for public queries
Name 11688 0
Mr Ross Paterson
Address 11688 0
University of Sydney
Faculty of Health Sciences
75 East St (PO BOX 170)
Lidcombe 1825
Country 11688 0
Australia
Phone 11688 0
61 2 9036 7309
Fax 11688 0
61 2 9351 9601
Email 11688 0
[email protected]
Contact person for scientific queries
Name 2616 0
A/Prof Sharon Kilbreath
Address 2616 0
University of Sydney
Faculty of Health Sciences
75 East St (PO BOX 170)
Lidcombe 1825
Country 2616 0
Australia
Phone 2616 0
61 2 9351 9272
Fax 2616 0
61 2 9351 9601
Email 2616 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.