Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer
Information source: Massachusetts General Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
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
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.
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.
- 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
- 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
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 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
Locations and Contacts
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