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An Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Mineral Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis

Phase 4
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

An Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Mineral Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis

Inclusion Criteria

Inclusion criteria:

- Signed informed consent

- Age > 18 years

- Histologically confirmed diagnosis of carcinoma of the prostate

- Objective evidence of metastatic disease to the bone as evidenced by bone scan or
radiograph at any point since their diagnosis of prostate cancer

- Currently receiving, or will begin receiving, hormonal therapy with an LHRH agonist
or other hormonal treatments for either < 6 months or > 6 months

- ECOG performance status of 0, 1, or 2

Exclusion criteria:

- Patients who are hormone sensitive without metastatic disease to the bone

- Patients who are hormone refractory typically defined as two or three consecutive
increases in PSA measured at least one month apart while on hormone therapy

- Patients who are not treated with LHRH agonist or other hormonal treatments

- Patients who are currently receiving diethylstilbestrol (DES) or PC-SPES

- Patients with another nonmalignant disease which would confound the evaluation of
primary endpoints or prevent the patient complying with the protocol.

- Patients with abnormal renal function as evidenced by either a serum creatinine
greater than 2 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

Type of Study:


Study Design:

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

Outcome Measure:

Changes in bone mineral density of the lumbar spine (L2-L4) at 12 months

Principal Investigator

Scott L. Pescatore, PharmD.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2002

Completion Date:

January 2004

Related Keywords:

  • Prostate Cancer
  • Hormone-sensitive Prostate Cancer
  • Prostate Cancer
  • Bone Metastasis
  • Neoplasm Metastasis
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases



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