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N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

Novartis

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis

Authority:

United States: Food and Drug Administration

Study ID:

CZOL446GUS63

NCT ID:

NCT00087659

Start Date:

December 2003

Completion Date:

May 2007

Related Keywords:

  • Prostate Cancer
  • ADT, BMD, US63, H014
  • Prostatic Neoplasms

Name

Location

Washington VA Medical CenterWashington, District of Columbia  20422
Atlanta Va Medical CenterDecatur, Georgia  30033
Tucson VA Medical CenterTucson, Arizona  85723
VA Medical Center - Long BeachLong Beach, California  90822
Veterans Affairs Medical CenterAugusta, Georgia  30904
West Sde VamcChicago, Illinois  60612
Hines VA Medical CenterHines, Illinois  60141
Louisville VAMCLouisville, Kentucky  40206
West Roxbury VAMCWest Roxbury, Massachusetts  02132
John D. Dingell VA Medical CenterDetroit, Michigan  48201
Department of Veterans AffairsMinneapolis, Minnesota  55417
Kansas City VAMCKansas City, Missouri  64128
Department of Veterans AffairsEast Orange, New Jersey  07018
VAWNY, BuffaloBuffalo, New York  14215
Portland/VancouverPortland, Oregon  97207
WJB Dorn Veteran Affairs Medical CenterColumbia, South Carolina  29209