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The Effect of Zoledronic Acid Compared to Placebo on Bone Mineral Density in Patients Undergoing Androgen Deprivation Therapy

Phase 4
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

The Effect of Zoledronic Acid Compared to Placebo on Bone Mineral Density in Patients Undergoing Androgen Deprivation Therapy

Inclusion Criteria

- Histologically confirmed diagnosis of carcinoma of the prostate

- No distant metastases (stage TNMO) (ie. prostate cancer without metastases)

- Patients within one year at the day of randomization from initiation of androgen
deprivation therapy with a LHRH agonist (with or without an antiandrogen) and with
the intended duration of androgen deprivation therapy of at least 12 months.
Patients may also enter if they have received an orchiectomy (or"ke-ek'te-me) within
two weeks of visit 1

- Patients who received any prior bisphosphonate therapy in the past 12 months will be

- Patients who are currently receiving diethylstilbesterol (DES) or PC-SPES (treatment
for osteoporosis) will be excluded

- Patients who have received prior treatment with systemic corticosteroids within the
past 12 months will be excluded (short term corticosteroid therapy, e.g. to
prevent/treat chemotherapy-induced nausea/vomiting or for acute illness like asthma
exacerbation, is acceptable)

- Other eligibility criteria may apply

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Percent change in bone mineral density of the lumbar spine (L2-L4) at one year.


United States: Food and Drug Administration

Study ID:




Start Date:

April 2003

Completion Date:

April 2005

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Bone Loss
  • Osteoporosis
  • Bone Mineral Density
  • Androgen Deprivation Therapy
  • Prostatic Neoplasms



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