A Prostate Cancer Study in Men Undergoing Androgen Deprivation Therapy

Prostate Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00087659
• Other study ID #: CZOL446GUS63
• Secondary ID: US63, US72 H014
• Status: Completed
• Phase: N/A
• First received: July 12, 2004
• Last updated: November 20, 2009
• Start date: December 2003
• Est. completion date: May 2007

Study information

• Verified date: November 2009
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to compare the effect of an investigational drug versus placebo on bone loss in men with prostate cancer who are receiving Androgen Deprivation Therapy (ADT). The study drug or placebo will be administered every three months of four treatments in one year.

In order to participate, male patients 18 years and older must be consecutive veterans from participating Veterans Administration Medical Centers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent

• Age > 18 years

• Histologically confirmed diagnosis of carcinoma of the prostate

• No distant metastases at the start of ADT and continuously low PSA (<2.0) on continuous ADT (stage Tany Nany MO).

• 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 at the time of randomization. Patients undergoing bilateral orchiectomy or with history of this procedure are also eligible.

• Patient with a baseline BMD T-score at or above -2.0 standard deviations in the lumbar spine (L2-L4) and the total hip are eligible

• Life expectancy of at least 12 months

• Zubrod performance status of 0, 1, or 2

Exclusion Criteria:

• Patients who received any prior bisphosphonate therapy in the past 6 months

• Metabolic bone disease including Paget's disease or hyperparathyroidism

• Radiographic evidence of bone metastases

• Patients who have received prior treatment with systemic corticosteroids within the past 12 months (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting or 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 clinical or radiological evidence of existing fracture in the lumbar spine and/or total hip

• Patients with a history of fracture with low-intensity or no associated trauma

• Patients with any prior treatment for osteoporosis

• 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

• History of surgery at the lumbosacral spine, with or without implantable devices, bilateral hip replacement or bilateral hip surgery with implantation of an appliance

• Patients treated with systemic investigational drugs(s) and /or device(s) within the past 30 days

• Patients with abnormal renal function as evidenced by either a serum creatinine greater than 3 mg/dL or by a calculated creatinine clearance of 60 ml/minute or less

• Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L)

• Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• zoledronic acid

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center	Augusta	Georgia
United States	VAWNY, Buffalo	Buffalo	New York
United States	West Sde Vamc	Chicago	Illinois
United States	WJB Dorn Veteran Affairs Medical Center	Columbia	South Carolina
United States	Atlanta VA Medical Center	Decatur	Georgia
United States	John D. Dingell VA Medical Center	Detroit	Michigan
United States	Department of Veterans Affairs	East Orange	New Jersey
United States	Hines VA Medical Center	Hines	Illinois
United States	Kansas City VAMC	Kansas City	Missouri
United States	VA Medical Center - Long Beach	Long Beach	California
United States	Louisville VAMC	Louisville	Kentucky
United States	Department of Veterans Affairs	Minneapolis	Minnesota
United States	Portland/Vancouver	Portland	Oregon
United States	Tucson VA Medical Center	Tucson	Arizona
United States	Washington VA Medical Center	Washington	District of Columbia
United States	West Roxbury VAMC	West Roxbury	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in bone mineral density of the lumbar spine (L2-L4) at 6 and 12 months.
Secondary	Percent change in bone mineral density of the total hip (including femoral neck, trachanteric region, and Ward's triangle) following one year of therapy.