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Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Bone Loss, Prostate Cancer

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Trial Information

Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer


- Patients will be randomized into 2 groups. At the screening visit, a bone mineral
density test will be performed to determine if the patient has osteoporosis or not.
Patients with osteoporosis will be treated with Zometa. Patients without osteoporosis
will be randomly assigned to receive either Zometa or a placebo.

- Zometa is administered intravenously over a 15 minute prior once in this one year
study.

- All patients will asked to take an over-the-counter oral calcium (500mg daily) and a
daily multi-vitamin (containing 400-500 I.U of vitamin D) during the study.

- All patients will have clinic visits every 3 months for blood tests and to report any
side effects they may be experiencing. At month 12, a bone mineral density test will
be repeated.


Inclusion Criteria:



- Adenocarcinoma of the prostate

- Current androgen deprivation therapy with expected duration of treatment greater than
or equal to 12 months

- Corrected serum calcium > 8.4mg/dl and < 10.6mg/dl

- Serum creatinine < 2.0mg/dl

Exclusion Criteria:

- History of bone metastases by bone scan

- Treatment with bisphosphonate within one year

- History of metabolic disease

- Chronic use of glucocorticoids, anticonvulsants, or suppressive doses of thyroxine
within one year

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

To compare change in bone mineral density from baseline to one year between men treated with Zometa (zoledronic acid) and men treated with placebo.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Matthew Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

03-194

NCT ID:

NCT00181584

Start Date:

September 2003

Completion Date:

Related Keywords:

  • Bone Loss
  • Prostate Cancer
  • Androgen deprivation therapy
  • bone loss
  • prostate cancer
  • Zoledronic Acid
  • Zometa
  • Bone Diseases, Metabolic
  • Prostatic Neoplasms

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617