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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00172055
First received: September 13, 2005
Last updated: June 15, 2011
Last verified: June 2011

September 13, 2005
June 15, 2011
December 2004
July 2009   (final data collection date for primary outcome measure)
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. [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00172055 on ClinicalTrials.gov Archive Site
If and to what extent rising levels of PSA can be used as an indicator for the development of bone metastases [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer Prostate
Drug: Zoledronic acid
Experimental: ZOL446 (zoledronic acid)
Intervention: Drug: Zoledronic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
218
Not Provided
July 2009   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00172055
CZOL446GBE03
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
Novartis
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP