Maintaining Bone Strength in Men With Prostate Cancer

NCT00391950 | Terminated Phase 3

• 1 other identifier: CZOL446GGB12
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Cancer treatment induced bone loss (CTIBL); Androgen deprivation therapy (ADT)

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

• 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.

Interventions

Zoledronic acid DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Unknown Facility

Derby, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis

  Novartis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 23, 2006
• First Posted: October 25, 2006
• Study Start: October 1, 2006
• Primary Completion: May 1, 2007
• Last Updated: November 23, 2009

Record last verified: 2009-11

Locations

GB (1)