Clinical trial NCT00172055: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer Prostate
Keywords: Zoledronic acid
Zometa
prostate cancer
osteoporosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: at 6 months
Secondary outcomes:
measure: If and to what extent rising levels of PSA can be used as an indicator for the development of bone metastases
timeFrame: at 6 months
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
facility: Novartis Investigative Site
city: Antwerpen
country: Belgium
facility: Novartis Investigative Site
city: Brugge
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Charleroi
country: Belgium
facility: Novartis Investigative Site
city: Edegem
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Gosselies
country: Belgium
facility: Novaris Investigative Site
city: Kortrijk
country: Belgium
facility: Novartis Investigative Site
city: Leper
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Libramont
country: Belgium
facility: Novaris Investigative Site
city: Mont-Godinne
country: Belgium
facility: Novartis Investigative Site
city: Roeselare
country: Belgium
facility: Novartis Investigative Site
city: Tongeren
country: Belgium
facility: Novartis Investigative Site
city: Tournai
country: Belgium
facility: Novartis Investigative Site
city: Turnhout
country: Belgium
facility: Novartis Investigative Site
city: Wilrijk
country: Belgium
facility: Novartis Investigative Site
city: Woluwe-Saint-Lambert
country: Belgium
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: