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Closed by the research committee
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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.
OBJECTIVES:
OUTLINE: Patients are stratified according to race (black vs other). Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | 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. |
|
| Arm II | Active Comparator | Patients receive oral calcium gluconate and oral cholecalciferol as in arm I. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol | Dietary Supplement | Given orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Density Change as Measured by Dual-energy X-ray Absorptiometry From Baseline to 13 Months | To assess bone density change as measured by dual-energy x-ray absorptiometry | Bone scan taken at baseline and month 13 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | To assess the percentage change in lumbar spine and hip bone density as measured by plain film x-rays of lumbar spine and pelvis | Lumbar spine and hip bone density taken at baseline and month 13. |
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DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Received at least 3 months of prior androgen deprivation therapy (no maximum amount/time) by either surgical or medical castration
Continued concurrent androgen deprivation therapy required throughout study participation
No bone metastases by baseline bone scan
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Charles L. Bennett, MD, PhD | Robert H. Lurie Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611-3013 | United States | ||
| Veterans Affairs Medical Center - Lakeside Chicago |
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PIs departure from the institution was sudden and due unforeseen serious circumstances. Due to this, no data was collected for this study nor can be reported on.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment With Zoledronate, Calcium and Cholecalciferol | 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 |
| FG001 | Treatment With Calcium and Cholecalciferol | Patients receive oral calcium gluconate and oral cholecalciferol as in arm I. cholecalciferol: Given orally calcium gluconate: Given orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Due to the unique situation of the PI, no data was collected for this study nor can be reported on.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With Zoledronate, Calcium and Cholecalciferol | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bone Density Change as Measured by Dual-energy X-ray Absorptiometry From Baseline to 13 Months | To assess bone density change as measured by dual-energy x-ray absorptiometry | Due to the unique situation of the PI, no data was collected for this study nor can be reported on. | Posted | Bone scan taken at baseline and month 13 |
|
Adverse events timeframe is not known. There is no data for this study.
Due to the unique situation of the PI, no data was collected for this study nor can be reported on.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment With Zoledronate, Calcium and Cholecalciferol | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Office | Northwestern University | 312-695-1301 |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D002125 | Calcium Gluconate |
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| calcium gluconate |
| Drug |
Given orally |
|
| zoledronic acid | Drug | Given IV |
|
| Markers of Bone Formation and Resorption |
To assess markers of bone formation and resorption. |
| 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) | To assess the incidence of skeletal events (pathologic and non-pathologic bone fractures, spinal cord compression, surgery to bone, and radiotherapy to bone) | 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 | To assess the incidence of new or progressive bone metastatic disease | Serum osteocalcin and serum bone alkaline phosphatase taken at baseline, month 6 and month 13. |
| Chicago |
| Illinois |
| 60611 |
| United States |
| John H. Stroger Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| BG001 |
| Treatment With Calcium and Cholecalciferol |
Patients receive oral calcium gluconate and oral cholecalciferol as in arm I. cholecalciferol: Given orally calcium gluconate: Given orally |
| BG002 | Total | Total of all reporting groups |
|
| Sex: Female, Male |
|
Patients receive oral calcium gluconate and oral cholecalciferol as in arm I. cholecalciferol: Given orally calcium gluconate: Given orally |
|
| Secondary | 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 | To assess the percentage change in lumbar spine and hip bone density as measured by plain film x-rays of lumbar spine and pelvis | Due to the unique situation of the PI, no data was collected for this study nor can be reported on. | Posted | Lumbar spine and hip bone density taken at baseline and month 13. |
|
|
| Secondary | Markers of Bone Formation and Resorption | To assess markers of bone formation and resorption. | Due to the unique situation of the PI, no data was collected for this study nor can be reported on. | Posted | Bone alkaline phosphatase taken at baseline, month 6 and month 13. |
|
|
| Secondary | Incidence of Skeletal Events (Pathologic and Non-pathologic Bone Fractures, Spinal Cord Compression, Surgery to Bone, and Radiotherapy to Bone) | To assess the incidence of skeletal events (pathologic and non-pathologic bone fractures, spinal cord compression, surgery to bone, and radiotherapy to bone) | Due to the unique situation of the PI, no data was collected for this study nor can be reported on. | Posted | 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. |
|
|
| Secondary | Incidence of New or Progressive Bone Metastatic Disease | To assess the incidence of new or progressive bone metastatic disease | Due to the unique situation of the PI, no data was collected for this study nor can be reported on. | Posted | Serum osteocalcin and serum bone alkaline phosphatase taken at baseline, month 6 and month 13. |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Treatment With Calcium and Cholecalciferol | Patients receive oral calcium gluconate and oral cholecalciferol as in arm I. cholecalciferol: Given orally calcium gluconate: Given orally | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D005942 | Gluconates |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |