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Prevention of Micro-architectural Bone Decay in Males With Non-metastatic Prostate Cancer Receiving Androgen Deprivation Therapy (ADT)

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2016 by Mathis Grossmann, Austin Health
Information provided by (Responsible Party):
Mathis Grossmann, Austin Health Identifier:
First received: November 1, 2009
Last updated: July 11, 2016
Last verified: July 2016

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.

Condition Intervention Phase
Prostate Cancer Drug: Zoledronic acid Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prevention of Micro-architectural Bone Decay in Males With Non-metastatic Prostate Cancer Receiving Androgen Deprivation Therapy (ADT)

Resource links provided by NLM:

Further study details as provided by Mathis Grossmann, Austin Health:

Primary Outcome Measures:
  • Bone microarchitecture [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Insulin resistance [ Time Frame: 24 months ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: zoledronic acid
Drug: Zoledronic acid
yearly infusion
Placebo Comparator: Placebo Drug: Placebo
yearly infusion

Detailed Description:
Not desired

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men with prostate cancer receiving ADT

Exclusion Criteria:

  • Contraindications to Zoledronic acid
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01006395

Contact: Mathis Grossmann, MD, PhD, FRACP 61394965000

Australia, Victoria
Austin Health Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Grossmann    61394965000      
Principal Investigator: Mathis Grossmann, MD PhD FRACP         
Sponsors and Collaborators
Austin Health
  More Information

Responsible Party: Mathis Grossmann, Associate Prof, Austin Health Identifier: NCT01006395     History of Changes
Other Study ID Numbers: MG2009_01
Study First Received: November 1, 2009
Last Updated: July 11, 2016

Keywords provided by Mathis Grossmann, Austin Health:
Prostate Cancer
Androgen deprivation
Bone Health
Insulin resistance
Men with nonmetastatic prostate cancer receiving androgen deprivation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Diseases, Male
Zoledronic acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on September 19, 2017