Maintaining Bone Strength in Men With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00391950
Recruitment Status : Terminated
First Posted : October 25, 2006
Last Update Posted : November 23, 2009
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Brief Summary:

The purpose of this study is to see if giving zoledronic acid three times a year is as effective as five times a year, in increasing bone strength in men with prostate cancer. All participants will receive the active drug but half will receive drug every 6 months and the other half will receive drug every 3 months. Both patient and doctor will know which treatment a patient is receiving.

After 1 year of treatment bone strength will be measured with scans and compared to the strength at the start of the study. All participants will stop receiving the drug after 1 year and will be seen back in the clinic, annually for another 2 years for follow-up.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Zoledronic acid Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Multicentre Study to Evaluate the Efficacy of Two Zoledronic Acid Schedules on Bone Mineral Density in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
Study Start Date : October 2006
Actual Primary Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Change in bone mineral density (BMD) at lumbar spine as assessed by dual energy x-ray absoptiometry (DEXA) scan

Secondary Outcome Measures :
  1. To compare the effect of zoledronic acid 4 mg every 12 weeks versus every 24 weeks on:
  2. The percent change in BMD of the total hip following one year of therapy and the forearm following one year of therapy. This will be carried out at a limited number of centres.
  3. Quality of life following one year of therapy.
  4. Various biochemical markers of bone resorption (N-telopeptide, NTX, C-telopeptide, CTX, TRACP, PINP) and bone formation (bone alkaline phosphatase, BAP) during one year of therapy. This will be carried out at a limited number of centres.
  5. Percentage of and rate of vertebral and hip fractures.
  6. Safety and tolerability

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

Inclusion criteria:

Histologically confirmed diagnosis of carcinoma of the prostate

  • No distant metastases
  • Patients must be candidates for androgen deprivation therapy (ADT)
  • Patient with a baseline BMD T-score at or below -1 standard deviations in the lumbar spine (L2-L4) are eligible

Exclusion criteria:

Patients with normal BMD at trial entry

  • Patients who received any prior bisphosphonate therapy in the past 12 months
  • Treatment with anti-androgen mono- or combination therapy
  • Patients who are currently receiving diethylstilbesterol (DES) or who have previously received PC-SPES
  • Patients who have received prior treatment with systemic corticosteroids within the past 12 months
  • Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months
  • Patients with any prior treatment for osteoporosis

Other protocol-defined inclusion/exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00391950

United Kingdom
Derby, United Kingdom
Sponsors and Collaborators
Study Chair: Novartis Novartis

Responsible Party: External Affairs, Novartis Identifier: NCT00391950     History of Changes
Other Study ID Numbers: CZOL446GGB12
First Posted: October 25, 2006    Key Record Dates
Last Update Posted: November 23, 2009
Last Verified: November 2009

Keywords provided by Novartis:
Prostate cancer
Cancer treatment induced bone loss (CTIBL)
Androgen deprivation therapy (ADT)

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