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:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00172055
First received: September 13, 2005
Last updated: June 15, 2011
Last verified: June 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cancer Prostate |
Drug: Zoledronic acid |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
prostate cancer
Drug Information available for:
Zoledronic acid
U.S. FDA Resources
Further study details as provided by Novartis:
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. [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 218 |
| Study Start Date: | December 2004 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ZOL446 (zoledronic acid) | Drug: Zoledronic acid |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00172055
Please refer to this study by its ClinicalTrials.gov identifier: NCT00172055
Locations
| 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, Belgium | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmeceuticals |
More Information
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00172055 History of Changes |
| Other Study ID Numbers: | CZOL446GBE03 |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 15, 2011 |
| Health Authority: | Belgium: Federal Agency for Medicines and Health Products, FAMHP |
Keywords provided by Novartis:
|
Zoledronic acid Zometa prostate cancer osteoporosis |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Bone Resorption Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases |
Bone Diseases Musculoskeletal Diseases Hormones Zoledronic acid Diphosphonates Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on September 30, 2016