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

NCT00058188 | Terminated Phase 3 Results DMC

• 1 other identifier: NU 02U1
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteoporosis; Prostate Cancer

Keywords

osteoporosis; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Bone Density Change as Measured by Dual-energy X-ray Absorptiometry From Baseline to 13 Months

  To assess bone density change as measured by dual-energy x-ray absorptiometry

  Bone scan taken at baseline and month 13

Secondary Outcomes (4)

• 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.

• Markers of Bone Formation and Resorption

  Bone alkaline phosphatase taken at baseline, month 6 and month 13.

• 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.

• Incidence of New or Progressive Bone Metastatic Disease

  Serum osteocalcin and serum bone alkaline phosphatase taken at baseline, month 6 and month 13.

Study Arms (2)

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; Drug: calcium gluconate; Drug: zoledronic acid

Arm II

ACTIVE COMPARATOR

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

Dietary Supplement: cholecalciferol; Drug: calcium gluconate

Interventions

cholecalciferol DIETARY_SUPPLEMENT

Given orally

Arm I; Arm II

calcium gluconate DRUG

Given orally

Arm I; Arm II

zoledronic acid DRUG

Given IV

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• Novartis: collaborator

Study Sites (3)

Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Veterans Affairs Medical Center - Lakeside Chicago

Chicago, Illinois, 60611, United States

Location

John H. Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Osteoporosis; Prostatic Neoplasms

Interventions

Cholecalciferol; Calcium Gluconate; Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Trials Office
• Organization: Northwestern University

312-695-1301

Study Officials

• Charles L. Bennett, MD, PhD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2003
• First Posted: April 9, 2003
• Study Start: March 1, 2003
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: December 8, 2020
• Results First Posted: November 19, 2020

Record last verified: 2020-10

Locations

US (3)