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

Sponsors and Collaborators:	Robert H. Lurie Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00058188

Purpose

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.

Condition	Intervention	Phase
Osteoporosis Prostate Cancer	Dietary Supplement: cholecalciferol Drug: calcium gluconate Drug: zoledronic acid	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: Calcium Cancer Osteoporosis Prostate Cancer X-Rays

Drug Information available for: Cholecalciferol Zoledronic acid Calcium gluconate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Bone density change as measured by dual-energy x-ray absorptiometry from baseline to13 months [ Designated as safety issue: No ]

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 [ Designated as safety issue: No ]
Markers of bone formation and resorption [ Designated as safety issue: No ]
Incidence of skeletal events (pathologic and non-pathologic bone fractures, spinal cord compression, surgery to bone, and radiotherapy to bone) [ Designated as safety issue: No ]
Incidence of new or progressive bone metastatic disease [ Designated as safety issue: No ]
Survival rate [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	January 2003
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Dietary Supplement: cholecalciferol Given orally Drug: calcium gluconate Given orally Drug: zoledronic acid Given IV
Arm II: Active Comparator Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.	Dietary Supplement: cholecalciferol Given orally Drug: calcium gluconate Given orally

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058188

Locations

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Robert H. Lurie Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Charles L. Bennett, MD, PhD

Robert H. Lurie Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Robert H. Lurie Comprehensive Cancer Center at Northwestern University ( Charles L. Bennett )
Study ID Numbers:	CDR0000287020, NU-02U1
Study First Received:	April 7, 2003
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00058188 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

osteoporosis
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:

Cholecalciferol
Zoledronic acid
Genital Neoplasms, Male
Prostatic Diseases
Osteoporosis
Bone Density Conservation Agents
Trace Elements
Bone Diseases, Metabolic
Urogenital Neoplasms
Genital Diseases, Male

Bone Diseases
Calcium, Dietary
Diphosphonates
Musculoskeletal Diseases
Vitamin D3
Vitamins
Calciferol
Micronutrients
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Cholecalciferol
Zoledronic acid
Genital Neoplasms, Male
Prostatic Diseases
Growth Substances
Physiological Effects of Drugs
Osteoporosis
Bone Density Conservation Agents
Bone Diseases, Metabolic
Urogenital Neoplasms

Genital Diseases, Male
Bone Diseases
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Musculoskeletal Diseases
Vitamins
Micronutrients
Prostatic Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009