Maintaining Bone Strength in Men With Prostate Cancer

This study has been terminated.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00391950
First received: October 23, 2006
Last updated: November 20, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: Zoledronic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • To compare the effect of zoledronic acid 4 mg every 12 weeks versus every 24 weeks on:
  • 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.
  • Quality of life following one year of therapy.
  • 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.
  • Percentage of and rate of vertebral and hip fractures.
  • Safety and tolerability

Estimated Enrollment: 300
Study Start Date: October 2006
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

  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: NCT00391950

Locations
United Kingdom
Derby, United Kingdom
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00391950     History of Changes
Other Study ID Numbers: CZOL446GGB12
Study First Received: October 23, 2006
Last Updated: November 20, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on August 01, 2014