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The objective of the study is to investigate whether blood markers can be used to predict the development of bone metastases and to assess the efficacy and safety of zoledronic acid in cancer treatment induced bone loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZOL446 (zoledronic acid) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic acid | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| If and to what extent rising levels of the bone resorption marker CTX can be used as an indicator for the development of bone metastases, diagnosed via bone scintigraphy. | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| If and to what extent rising levels of PSA can be used as an indicator for the development of bone metastases | at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmeceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Anderlecht | Belgium | ||||
| Novartis Investigative Site |
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| Antwerp |
| Belgium |
| Novartis Investigative Site | Bruges | Belgium |
| Novartis Investigative Site | Brussels | Belgium |
| Novartis Investigative Site | Charleroi | Belgium |
| Novartis Investigative Site | Edegem | Belgium |
| Novartis Investigative Site | Ghent | Belgium |
| Novaris Investigative Site | Gosselies | Belgium |
| Novartis Investigative Site | Kortrijk | Belgium |
| Novartis Investigative Site | Leper | Belgium |
| Novartis Investigative Site | Leuven | Belgium |
| Novaris Investigative Site | Libramont | Belgium |
| Novartis Investigative Site | Mont-Godinne | Belgium |
| Novartis Investigative Site | Roeselare | Belgium |
| Novartis Investigative Site | Tongeren | Belgium |
| Novartis Investigative Site | Tournai | Belgium |
| Novartis Investigative Site | Turnhout | Belgium |
| Novartis Investigative Site | Wilrijk | Belgium |
| Novartis Investigative Site | Woluwe-Saint-Lambert | Belgium |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D010024 | Osteoporosis |
| 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 |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic 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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