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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/NCT01006395




Registration number
NCT01006395
Ethics application status
Date submitted
1/11/2009
Date registered
1/11/2009
Date last updated
5/07/2019

Titles & IDs
Public title
Prevention of Micro-architectural Bone Decay in Males With Non-metastatic Prostate Cancer Receiving Androgen Deprivation Therapy (ADT)
Scientific title
Prevention of Micro-architectural Bone Decay in Males With Non-metastatic Prostate Cancer Receiving Androgen Deprivation Therapy (ADT)
Secondary ID [1] 0 0
MG2009_01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zoledronic acid
Treatment: Drugs - Placebo

Active Comparator: zoledronic acid - intervention

Placebo Comparator: Placebo -


Treatment: Drugs: Zoledronic acid
yearly infusion

Treatment: Drugs: Placebo
yearly infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Bone microarchitecture
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
Insulin resistance
Timepoint [1] 0 0
24 months

Eligibility
Key inclusion criteria
- Men with prostate cancer receiving ADT
Minimum age
18 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindications to Zoledronic acid

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 receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
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
1/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2019
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg

Funding & Sponsors
Primary sponsor type
Other
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Less than 20% of men in whom prostate cancer is diagnosed early die from it. Cardiovascular
disease is the most common cause of death in men with early prostate cancer. A commonly used
form of treatment for prostate cancer is androgen deprivation therapy (ADT). ADT, while
effective for the treatment of prostate cancer, has been linked to undesirable side effects,
such as an increased risk of bone fractures and diabetes. Bisphosphonates, a class of drugs
that prevent bone resorption, have been show to reduce the loss of bone mineral density that
occurs as a consequence of ADT, but the effects of bisphosphonates on preservation of bone
architecture is unknown.

This project has two main goals:

To assess prospectively, in men with prostate cancer receiving ADT, the effect of:

1. the intravenous bisphosphonate zoledronic acidon ADT-induced microarchitectural decay of
bone structure.

2. ADT on insulin resistance and glucose metabolism. We will recruit 100 ambulatory men
with non-metastatic prostate cancer who are about to commence a three year course of ADT
as per routine clinical practice at Austin Health. Men will be randomised to receive
either intravenous zoledronic acid (Aclasta, Novartis Pharmaceuticals) or placebo at
baseline and after 12 months of ADT. Men with contraindications to zoledronic acid will
be excluded from the study. All 100 study subjects will have clinical and laboratory
assessment at baseline, and at 3, 6, 12, 18 and 24 months (study end), and imaging
studies at baseline and at 6, 12 and 24 months.

The study protocol is outlined in more detail below (Please see flow chart included in the in

PICF):

Clinical and laboratory assessment:

Full medical history, physical examination and quality of life assessment using the SF-36
questionnaire. Laboratory studies will include: oral glucose tolerance test (3, 12 and 24
months Commercial-in-Confidence only) and measurements of measure total testosterone, fasting
glucose, C-peptide, HBA1c, bone turnover markers.

Imaging studies:

1. Bony micro-architecture by high resolution quantitative computed tomography

2. Bone mineral density and body composition by DEXA This project will have no direct
benefit for the subjects involved in this study; however, it will improve our
understanding on the effect of zoledronic acid on bone microarchitecture in men with
prostate cancer receiving ADT. It will also help us to better understand the effect of
ADT on insulin resistance and glucose metabolism.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01006395
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT01006395