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Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation

Primary Purpose

Osteoporosis, Prostate Cancer

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
cholecalciferol
calcium gluconate
zoledronic acid
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoporosis focused on measuring osteoporosis, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Northwestern University
  • Veterans Affairs Medical Center - Lakeside Chicago
  • John H. Stroger Hospital of Cook County

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I

Arm II

Arm Description

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.

Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Markers of Bone Formation and Resorption
To assess markers of bone formation and resorption.
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)
Incidence of New or Progressive Bone Metastatic Disease
To assess the incidence of new or progressive bone metastatic disease

Full Information

First Posted
April 7, 2003
Last Updated
November 18, 2020
Sponsor
Northwestern University
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00058188
Brief Title
Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Closed by the research committee
Study Start Date
March 2003 (Actual)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Prostate Cancer
Keywords
osteoporosis, stage III prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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 Title
Arm II
Arm Type
Active Comparator
Arm Description
Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
calcium gluconate
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
zoledronic acid
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Bone Density Change as Measured by Dual-energy X-ray Absorptiometry From Baseline to 13 Months
Description
To assess bone density change as measured by dual-energy x-ray absorptiometry
Time Frame
Bone scan taken at baseline and month 13
Secondary Outcome Measure Information:
Title
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
Description
To assess the percentage change in lumbar spine and hip bone density as measured by plain film x-rays of lumbar spine and pelvis
Time Frame
Lumbar spine and hip bone density taken at baseline and month 13.
Title
Markers of Bone Formation and Resorption
Description
To assess markers of bone formation and resorption.
Time Frame
Bone alkaline phosphatase taken at baseline, month 6 and month 13.
Title
Incidence of Skeletal Events (Pathologic and Non-pathologic Bone Fractures, Spinal Cord Compression, Surgery to Bone, and Radiotherapy to Bone)
Description
To assess the 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.
Title
Incidence of New or Progressive Bone Metastatic Disease
Description
To assess the 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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles L. Bennett, MD, PhD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Veterans Affairs Medical Center - Lakeside Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
John H. Stroger Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

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Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation

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