Cancer Prostate Clinical Trial
Official title:
Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy
Verified date | March 2017 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 218 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All stages of prostate cancer without bone metastases - No evidence of severe osteoporosis - ECOG performance status 0, 1 or 2 Exclusion Criteria: - Surgery / fracture at the lumbosacral spine, bilateral hip implants - Evidence of metabolic bone diseases, - Treatment with bisphosphonates or calcitonin within the previous year or chronic systemic corticosteroid treatment - Abnormal kidney or liver function - Other cancers within the last 5 years Other protocol-defined exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
Belgium | Novartis Investigative Site | Anderlecht | |
Belgium | Novartis Investigative Site | Antwerpen | |
Belgium | Novartis Investigative Site | Brugge | |
Belgium | Novartis Investigative Site | Bruxelles | |
Belgium | Novartis Investigative Site | Charleroi | |
Belgium | Novartis Investigative Site | Edegem | |
Belgium | Novartis Investigative Site | Gent | |
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 |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Secondary | 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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