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

Phase 3

Terminated

• Conditions: Osteoporosis; Prostate Cancer
• Interventions: Dietary Supplement: cholecalciferol; Drug: calcium gluconate; Drug: zoledronic acid

• Registration Number: NCT00058188
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2003-04-07
• Study First Submitted QC: 2003-04-08
• Study First Posted: 2003-04-09
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2020-10
• Results First Submitted: 2020-10-23
• Results First Submitted QC: 2020-10-23
• Last Update Submitted: 2020-11-18
• Results First Posted: 2020-11-19
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	cholecalciferol	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	cholecalciferol	Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.
Arm I	calcium gluconate	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 I	zoledronic acid	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	calcium gluconate	Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.

Primary Outcome Measures

Name	Time	Method
Bone Density Change as Measured by Dual-energy X-ray Absorptiometry From Baseline to 13 Months	Bone scan taken at baseline and month 13	To assess bone density change as measured by dual-energy x-ray absorptiometry

Secondary Outcome Measures

Name	Time	Method
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	Lumbar spine and hip bone density taken at baseline and month 13.	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	Bone alkaline phosphatase taken at baseline, month 6 and month 13.	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)	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.	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	Serum osteocalcin and serum bone alkaline phosphatase taken at baseline, month 6 and month 13.	To assess the incidence of new or progressive bone metastatic disease

Trial Locations

Locations (3)

John H. Stroger Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Veterans Affairs Medical Center - Lakeside Chicago; 🇺🇸 Chicago, Illinois, United States