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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00058188
First received: April 7, 2003
Last updated: August 4, 2014
Last verified: August 2014
  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 3

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:


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 2015
Estimated Primary Completion Date: December 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 4, 2014
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:
Prostatic Neoplasms
Osteoporosis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Zoledronic acid
Cholecalciferol
Androgens
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on September 22, 2014