Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis
- Conditions
- Prostate Cancer
- Registration Number
- NCT00035997
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this trial with Zometa is to investigate the effect ZOMETA 4 mg (zoledronic acid for injection in 100mg solution ) has in preventing associated bone loss in prostate cancer patients with bone metastasis when administered in conjunction with hormonal cancer therapy. This trial will seek to determine the effect of ZOMETA in stabilizing and increasing bone mineral density in these patients.
This prospective, open-label, single arm, multicenter study will enroll approximately 200 prostate cancer patients with a history of at least one documented bone lesion documented by bone scan or radiograph. Patients must already be receiving hormone therapy and meet the following additional criteria:
* 18 years of age or older
* Histologically confirmed diagnoses of prostate cancer
* Confirmed objective evidence of metastatic bone disease as evidenced by bone scan or radiograph
* Received or will receive hormonal treatment also know as androgen deprivation therapy with an LHRH agonist or other hormonal treatments
Throughout the course of this 12-month trial, patients will be identified based on the duration of established hormonal treatment at the time of enrollment. Each patients duration of participation will be up to 56 weeks including a 4 week screening, 48 week treatment and a 4 week follow up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 261
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Changes in bone mineral density of the lumbar spine (L2-L4) at 12 months
- Secondary Outcome Measures
Name Time Method Changes in biochemical markers of bone turnover over 12 months Changes in bone mineral density of the total hip at 12 months Time to first skeletal-related event Overall safety measured by adverse events (AEs)
Trial Locations
- Locations (56)
Norwood Clinic
🇺🇸Birmingham, Alabama, United States
Alaska Clinical Research Center, LLC
🇺🇸Anchorage, Alaska, United States
Advanced Urology Medical Center
🇺🇸Anaheim, California, United States
Urology Associates of Central CA
🇺🇸Fresno, California, United States
Center for Urological Research
🇺🇸La Mesa, California, United States
Atlantic Urological Medical Group
🇺🇸Long Beach, California, United States
Advanced Urology Medical Offices
🇺🇸Los Angeles, California, United States
Advanced Urology Medical Office
🇺🇸Los Angeles, California, United States
Boulder Medical Center
🇺🇸Boulder, Colorado, United States
Urology Associates, P.C.
🇺🇸Denver, Colorado, United States
Scroll for more (46 remaining)Norwood Clinic🇺🇸Birmingham, Alabama, United States