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

Mass General Brigham

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Bone Loss

Treatments

Drug: Zoledronic acid

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00181584

03-194

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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