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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
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

Study type
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

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

Key inclusion criteria
- Men with prostate cancer receiving ADT
Minimum age
18 Years
Maximum age
75 Years
Can healthy volunteers participate?
Key exclusion criteria
- Contraindications to Zoledronic acid

Study design
Purpose of the study
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
Other design features
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
Recruitment hospital [1] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg

Funding & Sponsors
Primary sponsor type
Austin Health

Ethics approval
Ethics application status

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


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
Trial related presentations / publications
Public notes

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
Other publications