COVID-19 studies are our top priority. For all other studies, we recommend commencing the registration process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission as we are experiencing 4 week turn-around time in review of submissions and resubmissions. We currently do not have the capacity to expedite reviews.

Note also there are additional delays to review of updates. We appreciate your patience.

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
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Whole-Body Vibration Treatment in Prostate Cancer Survivors on Androgen Suppression Therapy
Scientific title
The Effect of Whole-Body Vibration Treatment on Bone Metabolism in Prostate Cancer Survivors who are undergoing Androgen Suppression Therapy
Secondary ID [1] 279735 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 285580 0
Osteopenia 285581 0
Condition category
Condition code
Cancer 285774 285774 0 0
Musculoskeletal 285787 285787 0 0

Study type
Description of intervention(s) / exposure
Whole body vibration therapy (using a vibration device), 20 minutes, three times per week for 12 weeks. Vibration will be at 32-37Hz, 0.85mm peak-to-peak displacement, and at a magnitude of 0.3g.
Intervention code [1] 284032 0
Treatment: Devices
Intervention code [2] 284033 0
Comparator / control treatment
No treatment The control group will be offered the intervention after completion of the 12 week trial.
Control group

Primary outcome [1] 286293 0
Marker of bone formation - Serum Type 1 Procollagen N-terminal Propeptide (P1NP)
Timepoint [1] 286293 0
Baseline and after 12-weeks of intervention
Primary outcome [2] 286294 0
Marker of bone resorption - Urine analysis of N-telopeptide X/Creatinine (NTx/Cr)
Timepoint [2] 286294 0
Baseline and after 12-weeks of intervention
Secondary outcome [1] 295550 0
Fatigue - FACIT Fatigue Scale
Timepoint [1] 295550 0
Baseline and after 12-weeks of intervention
Secondary outcome [2] 295551 0
Physical Activity Levels - Godin Questionnaire, and sedentary time via domain specific sedentary questionnaire
Timepoint [2] 295551 0
Baseline and after 12-weeks of intervention
Secondary outcome [3] 295552 0
Body Composition - Dual-energy X-ray absorptiometry
Timepoint [3] 295552 0
Baseline and after 12-weeks of intervention
Secondary outcome [4] 295553 0
Physical functioning, 400m walk, static balance, stair climb, repeated chair rise, 6 meter walking tests
Timepoint [4] 295553 0
Baseline and after 12-weeks of intervention
Secondary outcome [5] 295554 0
Upper and Lower Body Strength - 1 Repetition Maximum assessment of chest press and leg press
Timepoint [5] 295554 0
Baseline and after 12-weeks of intervention
Secondary outcome [6] 295555 0
Serum 25-OH vitamin D status, testosterone levels, prostate specific antigen levels
Timepoint [6] 295555 0
Baseline and after 12-weeks of intervention
Secondary outcome [7] 295556 0
Quality of life measured by SF-36, and prostate specific concerns measured by The Expanded Prostate Cancer Index Composite Short Form
Timepoint [7] 295556 0
Baseline and after 12-weeks of intervention

Key inclusion criteria
Undergoing androgen suppression therapy for prostate cancer
and are within one year of initiation of treatment.
Willing to continue taking any bone altering medications or supplements they were previously taking for the duration of the study, including calcium and vitamin D.
Able to stand unassisted for sustained periods of time (i.e. 20 minutes)
Minimum age
18 Years
Maximum age
No limit
Can healthy volunteers participate?
Key exclusion criteria
Currently taking bisphosphonate medication;
Cognitive impairment;
Contraindications to vibration platform training (including pacemaker and fracture within the past six months);
Diagnosis of bone metastasis;
Diagnosis of diseases other than osteoporosis affecting bone

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Written informed consent will be required prior to any testing or randomisation. Assignments will be placed in sealed opaque envelopes and designated colours will be assigned for each group. The subject will open these envelopes after completion of all baseline testing. Subjects who dropout prior to completion of baseline testing will not be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects are randomised after the baseline assessment has been completed to: 1. Vibration training or 2. Wait-list control. Randomisation is at the level of the individual patient, and will be stratified by age, currently taking calcium or vitamin D, current exercise status. The list will be generated and maintained by a research assistant not otherwise involved in the study. The sequential treatment assignments are based on a computer-generated randomisation scheme (by using the Web site set up by Dr Gerard E. Dallal).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284517 0
Name [1] 284517 0
Australian Unity Foundation Heritage Fellowship
Address [1] 284517 0
Australian Unity Heritage Fellowships
The Australian Unity Foundation
114 Albert Road
South Melbourne VIC 3205
Country [1] 284517 0
Primary sponsor type
Edith Cowan University
270 Joondalup Drive
Joondalup, WA
Secondary sponsor category [1] 283446 0
Name [1] 283446 0
Dr. Carolyn Peddle-McIntyre
Address [1] 283446 0
270 Joondalup Drive
Joondalup, WA
Country [1] 283446 0
Other collaborator category [1] 260448 0
Name [1] 260448 0
Dr. Michael Baker
Address [1] 260448 0
270 Joondalup Drive
Joondalup, WA
Country [1] 260448 0
Other collaborator category [2] 260449 0
Name [2] 260449 0
A/Prof Daniel Galvao
Address [2] 260449 0
270 Joondalup Drive
Joondalup, WA
Country [2] 260449 0

Ethics approval
Ethics application status
Ethics committee name [1] 286502 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 286502 0
270 Joondalup Drive
Joondalup, WA
Ethics committee country [1] 286502 0
Date submitted for ethics approval [1] 286502 0
Approval date [1] 286502 0
Ethics approval number [1] 286502 0

Brief summary
This study aims to examine the effect of vibration therapy on markers of bone turnover in prostate cancer survivors on androgen suppression therapy.

Who is it for?
You may be eligible to join this study if you are a man currently taking an androgen suppression therapy for the treatment of prostate cancer.

Trial details.
Participants in this trial will be randomly (by chance) allocated to one of two groups. One group will undergo whole body vibration therapy. This involves standing on a gently vibrating platform for 20 minutes, three times per week over a period of 12 weeks. The other group will be assigned to no treatment for the 12 week trial period. After this time participants in this group will be offered the vibration treatment.

Participants will give blood and urine samples at baseline and at 12 weeks to examine markers of bone metabolism. They will also complete some tests of physical function and questionnaires about fatigue, quality of life and physical activity levels at these time points. It is thought that vibration training will decrease the breakdown of bone compared to no training.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 33636 0
Address 33636 0
Country 33636 0
Phone 33636 0
Fax 33636 0
Email 33636 0
Contact person for public queries
Name 16883 0
Dr. Carolyn McIntyre
Address 16883 0
270 Joondalup Drive
Joondalup, WA
Country 16883 0
Phone 16883 0
+61 08 6304 3987
Fax 16883 0
+61 8 6304 2499
Email 16883 0
Contact person for scientific queries
Name 7811 0
Dr. Carolyn McIntyre
Address 7811 0
270 Joondalup Drive
Joondalup, WA
Country 7811 0
Phone 7811 0
+61 8 6304 3987
Fax 7811 0
+61 8 6304 2499
Email 7811 0

No information has been provided regarding IPD availability
Summary results
No Results