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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00172055
• Other study ID #: CZOL446GBE03
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: March 2, 2017
• Start date: December 2004
• Est. completion date: July 2009

Study information

• Verified date: March 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Bone Resorption
• Cancer Prostate
• Prostatic Neoplasms

Intervention

Drug:
• Zoledronic acid

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Belgium, 

Outcome

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

External Links

•   Results for CZOL446GBE03 from the Novartis Clinical Trials website.