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

Sponsor:	Northwestern University
Collaborator:	Novartis
Information provided by (Responsible Party):	Northwestern University
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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care
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: Bone Density Calcium Cancer Osteoporosis Prostate Cancer X-Rays

Drug Information available for: Cholecalciferol Zoledronic acid Calcium gluconate Gluconic acid D-Gluconic acid, monosodium salt Manganese gluconate

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 [ Time Frame: Lumbar spine and hip bone density taken at baseline and month 13. ] [ Designated as safety issue: No ]
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 [ Time Frame: Bone alkaline phosphatase taken at baseline, month 6 and month 13. ] [ Designated as safety issue: No ]
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) [ 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. ] [ Designated as safety issue: No ]
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 [ Time Frame: Serum osteocalcin and serum bone alkaline phosphatase taken at baseline, month 6 and month 13. ] [ Designated as safety issue: No ]
To assess the incidence of new or progressive bone metastatic disease

Estimated Enrollment:	70
Study Start Date:	March 2003
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Dietary Supplement: cholecalciferol Given orally Drug: calcium gluconate Given orally Drug: zoledronic acid Given IV
Active Comparator: Arm II 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
Northwestern University
Chicago, Illinois, United States, 60611-3013
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States, 60611
John H. Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612

Sponsors and Collaborators

Northwestern University

Novartis

Investigators

Study Chair:

Charles L. Bennett, MD, PhD

Robert H. Lurie Cancer Center

More Information

No publications provided

Responsible Party:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00058188 History of Changes
Other Study ID Numbers:	NU 02U1
Study First Received:	April 7, 2003
Last Updated:	August 24, 2011
Health Authority:	United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Northwestern University:

osteoporosis
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:

Osteoporosis
Prostatic Neoplasms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

Androgens
Cholecalciferol
Zoledronic acid
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on February 12, 2012