The objective of MER-101-03 is to examine the effects of two different dosing regimens of MER-101 20mg tablets versus Zometa 4mg IV infusion once-monthly therapy. The effects will be monitored on a weekly basis by measuring various markers of bone metabolism. Patients to be enrolled will be those who have not received any previous bisphosphonate therapy. The study will be carried out on prostate cancer patients who are no longer on hormone therapy. Treatment in the study will be for a 2-month period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Oral enteric coated tablets, 20mg, weekly, 8 weeks
Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks
Oral enteric coated tablets, 20mg, once a day for 4 consecutive days during week 1, weekly for weeks 5, 6, 7, 8
Birmingham Hematology & Oncology Associates, LLC
Birmingham, Alabama, United States
Cancer Care of North Florida, P.A.
Lake City, Florida, United States
Lakeland Regional Cancer Center
Lakeland, Florida, United States
Innovative Medical Research of South Florida, Inc.
Miami, Florida, United States
Green Clinic, LLC
Ruston, Louisiana, United States
New York Urological Associates, PC
New York, New York, United States
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, United States
Cancer Outreach Associates, P.C.
Abingdon, Virginia, United States
East Tallinn Central Hospital
Tallinn, Estonia
North Estonian Regional Hospital
Tallinn, Estonia
...and 3 more locations
Effects on 4 markers of bone metabolism
Time frame: Weekly
Brief Pain Inventory
Time frame: Monthly
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.