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

NCT ID: NCT00058188

Last Updated: 2020-12-08

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoporosis Prostate Cancer

Keywords

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osteoporosis stage III prostate cancer stage IV prostate cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

Given orally

calcium gluconate

Intervention Type DRUG

Given orally

zoledronic acid

Intervention Type DRUG

Given IV

Arm II

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

Group Type ACTIVE_COMPARATOR

cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

Given orally

calcium gluconate

Intervention Type DRUG

Given orally

Interventions

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cholecalciferol

Given orally

Intervention Type DIETARY_SUPPLEMENT

calcium gluconate

Given orally

Intervention Type DRUG

zoledronic acid

Given IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles L. Bennett, MD, PhD

Role: STUDY_CHAIR

Robert H. Lurie Cancer Center

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Veterans Affairs Medical Center - Lakeside Chicago

Chicago, Illinois, United States

Site Status

John H. Stroger Hospital of Cook County

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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NU 02U1

Identifier Type: -

Identifier Source: org_study_id