The Effect of Zoledronic Acid on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
- Conditions
- Prostate Cancer
- Registration Number
- NCT00063609
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this study is to compare the effect of an investigational drug used intravenously and placebo administered every three months for one year, on bone loss associated with initial androgen deprivation) in men with prostate cancer without metastasis. In order to participate in this trial male patients must be 18 years of age or older and have been diagnosed with prostate cancer without metastasis and within one year of starting their androgen deprivation therapy at the day of randomization onto this trial. In addition, patients who have undergone a recent orchiectomy (or"ke-ek'te-me) (removal of one or two testes) are eligible to participate.
Patients who received any prior bisphosphonate therapy or prior treatment with systemic corticosteroids within in the past 12 months are not eligible to participate. Also patients who are receiving treatment for osteoporosis are not eligible to participate.
Inclusion into this clinical trial with this investigational drug is based on the protocol entry criteria and evaluation from a participating trial investigator.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percent change in bone mineral density of the lumbar spine (L2-L4) at one year.
- Secondary Outcome Measures
Name Time Method Percent changes in bone mineral density of the total hip biochemical markers of bone turnover at one year
Trial Locations
- Locations (44)
Millennium Therapeutics & Research
🇺🇸Birmingham, Alabama, United States
Medical Affiliated Research Center
🇺🇸Huntsville, Alabama, United States
Alaska Clinical Research Center
🇺🇸Anchorage, Alaska, United States
Advanced Clinical Therapeutics
🇺🇸Tucson, Arizona, United States
Donald Gleason, MD
🇺🇸Tucson, Arizona, United States
Arkansas Urology
🇺🇸Little Rock, Arkansas, United States
Advanced Urology Med. Center
🇺🇸Anaheim, California, United States
Atlantic Urological Medical Group
🇺🇸Long Beach, California, United States
San Diego Uro. Research
🇺🇸San Diego, California, United States
Western Clinical Research
🇺🇸Torrance, California, United States
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