Overview

This trial is active, not recruiting.

Conditions osteoporosis, prostate cancer
Treatments cholecalciferol, calcium gluconate, zoledronic acid
Phase phase 3
Sponsor Northwestern University
Collaborator Novartis
Start date March 2003
End date December 2016
Trial size 70 participants
Trial identifier NCT00058188, NU 02U1

Summary

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: Randomized phase 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
cholecalciferol
Given orally
calcium gluconate
Given orally
zoledronic acid
Given IV
(Active Comparator)
Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.
cholecalciferol
Given orally
calcium gluconate
Given orally

Primary Outcomes

Measure
Bone density change as measured by dual-energy x-ray absorptiometry from baseline to 13 months
time frame: Bone scan taken at baseline and month 13

Secondary Outcomes

Measure
Percentage change in lumbar spine and hip bone density as measured by plain film x-rays of lumbar spine and pelvis from baseline to 13 months
time frame: Lumbar spine and hip bone density taken at baseline and month 13.
Markers of bone formation and resorption
time frame: Bone alkaline phosphatase taken at baseline, month 6 and month 13.
Incidence of skeletal events (pathologic and non-pathologic bone fractures, spinal cord compression, surgery to bone, and radiotherapy to bone)
time frame: PSA taken at baseline, month 3, month 6, month 9, month 12 and month 13. CT scan of abdomen and pelvis taken at baseline and month 13. Serum testosterone, estradiol, parathyroid taken at baseline, month 6 and month 13.
Incidence of new or progressive bone metastatic disease
time frame: Serum osteocalcin and serum bone alkaline phosphatase taken at baseline, month 6 and month 13.

Eligibility Criteria

Male participants at least 18 years old.

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)

Additional Information

Official title A Phase III Randomized Study of Zolendronate Bisphosphonate Therapy for the Prevention of Bone Loss in Men With Prostate Cancer Receiving Long-Term Androgen Deprivation
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Northwestern University.