Clinical trial NCT00391950: Maintaining Bone Strength in Men With Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate cancer
Cancer treatment induced bone loss (CTIBL)
Androgen deprivation therapy (ADT)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-10-25
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in bone mineral density (BMD) at lumbar spine as assessed by dual energy x-ray absoptiometry (DEXA) scan
Secondary outcomes:
measure: To compare the effect of zoledronic acid 4 mg every 12 weeks versus every 24 weeks on:
measure: 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.
measure: Quality of life following one year of therapy.
measure: 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.
measure: Percentage of and rate of vertebral and hip fractures.
measure: Safety and tolerability
Other outcomes:
Locations:
city: Derby
country: United Kingdom
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References: