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18 Years
Not Enrolling
Prostate Cancer

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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

- 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,

- 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

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

Type of Study:


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


Investigator Role:

Study Chair

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2003

Completion Date:

May 2007

Related Keywords:

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



Washington VA Medical Center Washington, District of Columbia  20422
Atlanta Va Medical Center Decatur, Georgia  30033
Tucson VA Medical Center Tucson, Arizona  85723
VA Medical Center - Long Beach Long Beach, California  90822
Veterans Affairs Medical Center Augusta, Georgia  30904
West Sde Vamc Chicago, Illinois  60612
Hines VA Medical Center Hines, Illinois  60141
Louisville VAMC Louisville, Kentucky  40206
West Roxbury VAMC West Roxbury, Massachusetts  02132
John D. Dingell VA Medical Center Detroit, Michigan  48201
Department of Veterans Affairs Minneapolis, Minnesota  55417
Kansas City VAMC Kansas City, Missouri  64128
Department of Veterans Affairs East Orange, New Jersey  07018
VAWNY, Buffalo Buffalo, New York  14215
Portland/Vancouver Portland, Oregon  97207
WJB Dorn Veteran Affairs Medical Center Columbia, South Carolina  29209