Trial record 10 of 51 for:    prostate cancer prevention | Open Studies

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 June 2014 by Austin Health
Sponsor:
Information provided by (Responsible Party):
Mathis Grossmann, Austin Health
ClinicalTrials.gov Identifier:
NCT01006395
First received: November 1, 2009
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Austin Health:

Primary Outcome Measures:
  • Bone microarchitecture [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin resistance [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: zoledronic acid
intervention
Drug: Zoledronic acid
yearly infusion
Placebo Comparator: Placebo Drug: Placebo
yearly infusion

Detailed Description:

Not desired

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01006395

Contacts
Contact: Mathis Grossmann, MD, PhD, FRACP 61394965000 mathisg@unimelb.edu.au

Locations
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

No publications provided

Responsible Party: Mathis Grossmann, Associate Prof, Austin Health
ClinicalTrials.gov Identifier: NCT01006395     History of Changes
Other Study ID Numbers: MG2009_01
Study First Received: November 1, 2009
Last Updated: June 30, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by 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
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Genital Diseases, Male
Androgens
Zoledronic acid
Bone Density Conservation Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014