The Use of Zoledronic Acid in Men on Androgen Deprivation Therapy for Prostate Cancer With Preexisting Osteoporosis

NCT00171639 | Completed Phase 3

• 1 other identifier: CZOL446EUS72
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 7

Brief Summary

This study is being conducted to evaluate the effect of an investigational drug on bone loss in men with prostate cancer who are receiving Androgen Deprivation Therapy (ADT). In order to participate, male patients 18 years and older must be veterans from participating Veterans Administration Medical Centers that are receiving ADT for prostate cancer and have established osteoporosis.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Percent change in bone mineral density of the lumbar spine (L2-L4) at 6 and 12 months.

  12 months

Secondary Outcomes (1)

• Percent change in bone mineral density of the total hip (including femoral neck, trochanteric region, and Ward's triangle) following one year of therapy.

  12 months

Interventions

zoledronic acid DRUG

Eligibility Criteria

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

You may qualify if:

• Signed informed consent
• Age \> 18 years
• Histologically confirmed diagnosis of carcinoma of the prostate
• Stage M0: Patients just starting ADT must be stage M0 \[PSA \<10 (then bone scan not needed) or negative bone scan (regardless of PSA)\]. Patients already on ADT must have been M0 at the initiation of ADT and have maintained a stable, low PSA (\< 2.0) on continuous ADT since that time.
• Patients initiating or receiving ADT with a LHRH agonist (with or without an antiandrogen) and with the intended duration of ADT of at least 12 months from the time of randomization. Patients undergoing bilateral orchiectomy or with history of this procedure are also eligible. For patients already on ADT, the therapy must be continuous, and if there is more than one missed or delayed dose (\> 1 mo delay) in any one year period, the patient is not eligible.
• Patient with a baseline BMD T-score \<-2.0 in the lumbar spine (L2-L4) and/or the total hip are eligible
• Life expectancy of at least 12 months
• Zubrod performance status of 0, 1, or 2

You may not qualify if:

• Patients who received any bisphosphonate therapy in the past 6 months
• Metabolic bone disease including Paget's disease or hyperparathyroidism or vitamin D deficiency. Patients with vitamin D deficiency or secondary hyperparathyroidism due to vitamin D deficiency may be treated and reassessed for consideration for the trial, as detailed in Appendix 9.
• Radiographic evidence of bone metastases
• Patients who have received treatment with systemic corticosteroids within the past 12 months (short term corticosteroid therapy for up to one month duration, e.g. for acute illness like asthma exacerbation, is acceptable)
• Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months
• Current treatment with estrogen or complementary medicines known to contain estrogens
• Patients with previous or concomitant malignancy within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin, and colonic polyps with non-invasive malignancy which have been removed
• Patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol, including:
• uncontrolled infections
• uncontrolled type 2 diabetes mellitus
• diseases with influence on bone metabolism, such as Paget's disease or uncontrolled thyroid or parathyroid dysfunction
• cardiovascular, renal, hepatic, pulmonary and neurologic/psychiatric diseases which would prevent prolonged follow-up
• Patients with clinical or radiological evidence of existing fracture in the lumbar spine or either hip
• Patients with history of lumbar spine surgery that directly involved the bone or resulted in implanted hardware; or rendered the lumbar spine not evaluable (Some patients with a history of laminectomy alone may qualify).
• Patients with history of unilateral fracture of hip due to trauma or unilateral hip surgery and the other hip and lumbar spine are not evaluable.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (7)

Southern AZ VA Health Care System

Tucson, Arizona, 85723, United States

Location

VA Medical Center-Long Beach

Long Beach, California, 90822, United States

Location

Washington VA Medical Center

Washington D.C., District of Columbia, 20422, United States

Location

West Side VMAC

Chicago, Illinois, 60612, United States

Location

Hines VA Medical Center

Hines, Illinois, 60141, United States

Location

Kansas City VMAC

Kansas City, Missouri, 64128, United States

Location

VAWNY Buffalo

Buffalo, New York, 14215, United States

Location

Related Publications (1)

• Campbell SC, Bhoopalam N, Moritz TE, Pandya M, Iyer P, Vanveldhuizen P, Ellis NK, Thottapurathu L, Garewal H, Warren SR, Friedman N, Reda DJ. The use of zoledronic acid in men receiving androgen deprivation therapy for prostate cancer with severe osteopenia or osteoporosis. Urology. 2010 May;75(5):1138-43. doi: 10.1016/j.urology.2009.11.083. Epub 2010 Mar 19.

  PMID: 20303574 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nirmala Bhoopalam, MD

  Hines VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: June 1, 2004
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

US (7)