Prostate Cancer
Conditions
Keywords
Prostate cancer, Cancer treatment induced bone loss (CTIBL), Androgen deprivation therapy (ADT)
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.
Interventions
DRUGZoledronic acid
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in bone mineral density (BMD) at lumbar spine as assessed by dual energy x-ray absoptiometry (DEXA) scan | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
| To compare the effect of zoledronic acid 4 mg every 12 weeks versus every 24 weeks on: | — |
| Percentage of and rate of vertebral and hip fractures. | — |
| Safety and tolerability | — |
| 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. | — |
Countries
United Kingdom
Outcome results
None listed