Maintaining Bone Strength in Men With Prostate Cancer - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00391950

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 III

MedlinePlus related topics: Cancer Minerals Prostate Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
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

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

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

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CZOL446GGB12
Study First Received:	October 23, 2006
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00391950 History of Changes
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)

Study placed in the following topic categories:

Zoledronic acid
Prostatic Diseases
Genital Neoplasms, Male
Bone Density Conservation Agents

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Neoplasms
Zoledronic acid
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Physiological Effects of Drugs

Bone Density Conservation Agents
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009