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
- Registration Number
- NCT00172055
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 218
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ZOL446 (zoledronic acid) Zoledronic acid -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method If and to what extent rising levels of PSA can be used as an indicator for the development of bone metastases at 6 months
Trial Locations
- Locations (2)
Novaris Investigative Site
🇧🇪Libramont, Belgium
Novartis Investigative Site
🇧🇪Woluwe-Saint-Lambert, Belgium