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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00172055

Collaborator

(none)

218

Enrollment

Locations

Arm

Duration (Months)

11.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Prostate	Drug: Zoledronic acid	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

218 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 2004

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ZOL446 (zoledronic acid)	Drug: Zoledronic acid

Arm

Intervention/Treatment

Experimental: ZOL446 (zoledronic acid)

Drug: Zoledronic acid

Outcome Measures

Primary Outcome Measures

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

If and to what extent rising levels of PSA can be used as an indicator for the development of bone metastases [at 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Novartis Investigative Site	Anderlecht	Belgium
2	Novartis Investigative Site	Antwerpen	Belgium
3	Novartis Investigative Site	Brugge	Belgium
4	Novartis Investigative Site	Bruxelles	Belgium
5	Novartis Investigative Site	Charleroi	Belgium
6	Novartis Investigative Site	Edegem	Belgium
7	Novartis Investigative Site	Gent	Belgium
8	Novaris Investigative Site	Gosselies	Belgium
9	Novartis Investigative Site	Kortrijk	Belgium
10	Novartis Investigative Site	Leper	Belgium
11	Novartis Investigative Site	Leuven	Belgium
12	Novaris Investigative Site	Libramont	Belgium
13	Novartis Investigative Site	Mont-Godinne	Belgium
14	Novartis Investigative Site	Roeselare	Belgium
15	Novartis Investigative Site	Tongeren	Belgium
16	Novartis Investigative Site	Tournai	Belgium
17	Novartis Investigative Site	Turnhout	Belgium
18	Novartis Investigative Site	Wilrijk	Belgium
19	Novartis Investigative Site	Woluwe-Saint-Lambert	Belgium