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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Experimental | MER-101 20mg Tablets Regimen 1 |
|
| C | Experimental | MER-101 20mg Tablets Regimen 2 |
|
| A | Active Comparator | Zometa Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic Acid 20mg Tablets | Drug | Oral enteric coated tablets, 20mg, weekly, 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effects on 4 markers of bone metabolism | Weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory | Monthly |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas W Leonard, PhD | Merrion Pharmaceuticals, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Hematology & Oncology Associates, LLC | Birmingham | Alabama | 35223 | United States | ||
| Cancer Care of North Florida, P.A. |
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| Zoledronic Acid | Drug | Zoledronic Acid infusion, 4mg, every 4 weeks for 8 weeks |
|
|
| Zoledronic Acid 20mg Tablets | Drug | Oral enteric coated tablets, 20mg, once a day for 4 consecutive days during week 1, weekly for weeks 5, 6, 7, 8 |
|
|
| Lake City |
| Florida |
| 32055 |
| United States |
| Lakeland Regional Cancer Center | Lakeland | Florida | 33805 | United States |
| Innovative Medical Research of South Florida, Inc. | Miami | Florida | 33179 | United States |
| Green Clinic, LLC | Ruston | Louisiana | 71270 | United States |
| New York Urological Associates, PC | New York | New York | 10022 | United States |
| Charleston Hematology Oncology Associates, PA | Charleston | South Carolina | 29403 | United States |
| Cancer Outreach Associates, P.C. | Abingdon | Virginia | 24211 | United States |
| East Tallinn Central Hospital | Tallinn | Estonia |
| North Estonian Regional Hospital | Tallinn | Estonia |
| Tartu University Hospital | Tartu | Estonia |
| O. Hublarovs Private Practice | Daugavpils | Latvia |
| P. Stradina Clinical University Hospital | Riga | Latvia |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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