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Zoledronate in Preventing Bone Loss Caused By Long-Term Androgen Deprivation Therapy in Patients With Stage III or Stage IV Prostate Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Zoledronate in Preventing Bone Loss Caused By Long-Term Androgen Deprivation Therapy in Patients With Stage III or Stage IV Prostate Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Zoledronate in Preventing Bone Loss Caused By Long-Term Androgen Deprivation Therapy in Patients With Stage III or Stage IV Prostate Cancer Clinical research trials and Zoledronate in Preventing Bone Loss Caused By Long-Term Androgen Deprivation Therapy in Patients With Stage III or Stage IV Prostate Cancer health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Zoledronate in Preventing Bone Loss Caused By Long-Term Androgen Deprivation Therapy in Patients With Stage III or Stage IV Prostate Cancer. Zoledronate in Preventing Bone Loss Caused By Long-Term Androgen Deprivation Therapy in Patients With Stage III or Stage IV Prostate Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Zoledronate in Preventing Bone Loss Caused By Long-Term Androgen Deprivation Therapy in Patients With Stage III or Stage IV Prostate Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Zoledronate in Preventing Bone Loss Caused By Long-Term Androgen Deprivation Therapy in Patients With Stage III or Stage IV Prostate Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.

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Zoledronate in Preventing Bone Loss Caused By Long-Term Androgen Deprivation Therapy in Patients With Stage III or Stage IV Prostate Cancer



Zoledronate in Preventing Bone Loss Caused By Long-Term Androgen Deprivation Therapy in Patients With Stage III or Stage IV Prostate Cancer

For Condition: Hypercalcemia,stage 4 prostate cancer,stage 3 prostate cancer
Status: Recruiting
Sponsor(s): Robert H. Lurie Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss. PURPOSE: Randomizedphase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term androgen deprivation therapy.
Details: OBJECTIVES: - Compare bone loss in patients receiving long-term androgen deprivation therapy for stage III or IV prostate cancer when treated with supportive care with vs without zoledronate. - Compare the percentage change in lumbar spine and hip bone density in patients treated with these regimens. - Compare markers of bone formation and resorption in patients treated with these regimens. - Compare the incidence of skeletal events (pathologic and non-pathologic bone fractures, spinal cord compression, surgery to bone, and radiotherapy to bone) in patients treated with these regimens. - Compare the incidence of new or progressive bone metastatic disease in patients treated with these regimens. - Compare the survival rate of patients treated with these regimens. OUTLINE: Patients are stratified according to race (black vs other). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity. - Arm II: Patients receive oral calcium gluconate and oral cholecalciferol as in arm I. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed prostate cancer - Stage III or IV disease - Received at least 3 months of prior androgen deprivation therapy (no maximum amount/time) by either surgical or medical castration - Medical castration may be by intermittent or continuous androgen suppression via single- or combined-drug androgen blockade - Continued concurrent androgen deprivation therapy required throughout study participation - No bone metastases by baseline bone scan PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 1 year Hematopoietic - Not specified Hepatic - Bilirubin less than 3 times upper limit of normal (ULN) - AST and ALT less than 3 times ULN - No chronic liver disease Renal - Creatinine no greater than 2.0 mg/dL Other - Fertile patients must use effective contraception - No Paget's disease - No Cushing's disease - No hyperthyroidism - No hyperprolactinemia PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Prior chemotherapy for prostate cancer allowed Endocrine therapy - See Disease Characteristics - More than 12 months since prior suppressive doses of thyroxine or calcitonin - More than 6 months since prior corticosteroids - Concurrent corticosteroids allowed (after enrollment on study) Radiotherapy - Prior radiotherapy for prostate cancer allowed Surgery - See Disease Characteristics Other - More than 12 months since prior bisphosphonate therapy (oral or IV)
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
CharlesBennett,  Study Chair,  Robert H. Lurie Cancer Center

Veterans Affairs Medical Center - Lakeside Chicago *Recruiting*
Chicago,  Illinois,  60611
United States
Recruiting Charles  Bennett 312-469-4415

Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago,  Illinois,  60611
United States
Recruiting Charles  Bennett 312-469-4415


Additional Information:
Study ID Numbers:  CDR0000287020;  NU-02U1
Study Start Date: 
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058188

Other Stage 3 Prostate Cancer Studies:
1. Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer

2. Calcitriol Plus Dexamethasone in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

3. Assessing Quality of Life of Patients With Prostate Cancer

4. Calcitriol and Zoledronate in Treating Patients With Progressive Prostate Cancer

5. Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients with Prostate Cancer

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