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

Condition(s) targeted: Bone Loss; Prostate Cancer

Intervention: Zoledronic acid (Drug); Placebo (Other)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Matthew Smith, MD, Principal Investigator, Affiliation: Massachusetts General Hospital

The primary objective of this study is to determine whether zoledronic acid (Zometa) given once annually increases bone mineral density in men receiving hormone therapy for prostate cancer.

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

Study design: Prevention, Randomized, Single Blind (Subject), Placebo Control, Factorial Assignment, Safety/Efficacy Study

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

Secondary outcome:

To compare changes in biochemical markers of bone turnover between men treated with zoledronic acid and men treated with placebo

to assess the safety and tolerability of zoledronic acid.

Detailed description:

- 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Starting date: September 2003
Last updated: December 28, 2007