Maintaining Bone Strength in Men With Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00391950
• Other study ID #: CZOL446GGB12
• Status: Terminated
• Phase: Phase 3
• First received: October 23, 2006
• Last updated: November 20, 2009
• Start date: October 2006

Study information

• Verified date: November 2009
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Zoledronic acid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bone mineral density (BMD) at lumbar spine as assessed by dual energy x-ray absoptiometry (DEXA) scan
Secondary	To compare the effect of zoledronic acid 4 mg every 12 weeks versus every 24 weeks on:
Secondary	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.
Secondary	Quality of life following one year of therapy.
Secondary	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.
Secondary	Percentage of and rate of vertebral and hip fractures.
Secondary	Safety and tolerability