NCT01006395

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. 1.the intravenous bisphosphonate zoledronic acidon ADT-induced microarchitectural decay of bone structure.
  2. 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.
  3. 3.Bony micro-architecture by high resolution quantitative computed tomography
  4. 4.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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

8.3 years

First QC Date

November 1, 2009

Last Update Submit

July 2, 2019

Conditions

Prostate Cancer

Keywords

Prostate CancerAndrogen deprivationBone HealthInsulin resistanceMen with nonmetastatic prostate cancer receiving androgen deprivation

Outcome Measures

Primary Outcomes (1)

  • Bone microarchitecture

    24 months

Secondary Outcomes (1)

  • Insulin resistance

    24 months

Study Arms (2)

zoledronic acid

ACTIVE COMPARATOR

intervention

Drug: Zoledronic acid

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Zoledronic acidDRUG

yearly infusion

zoledronic acid
PlaceboDRUG

yearly infusion

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men with prostate cancer receiving ADT

You may not qualify if:

  • Contraindications to Zoledronic acid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Related Publications (1)

  • Cheung AS, Hoermann R, Zhu J, Lim Joon D, Zajac JD, Grossmann M. Zoledronic acid does not affect insulin resistance in men receiving androgen deprivation therapy: a prespecified secondary analysis of a randomised controlled trial. Ther Adv Endocrinol Metab. 2021 May 5;12:20420188211012118. doi: 10.1177/20420188211012118. eCollection 2021.

    PMID: 34104395DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsInsulin Resistance

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof

Study Record Dates

First Submitted

November 1, 2009

First Posted

November 2, 2009

Study Start

January 1, 2011

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations

AU(1)