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
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| ClinicalTrials.gov Identifier: NCT00172055 |
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Recruitment Status
:
Completed
First Posted
: September 15, 2005
Last Update Posted
: March 6, 2017
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 218 participants |
| 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 : | December 2004 |
| Actual Primary Completion Date : | July 2009 |
| Actual Study Completion Date : | July 2009 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Prostate cancer
Drug Information available for:
Zoledronic acid
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
| Experimental: ZOL446 (zoledronic acid) | Drug: Zoledronic acid |
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 ]
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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Additional Information:
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00172055 History of Changes |
| Other Study ID Numbers: |
CZOL446GBE03 |
| First Posted: | September 15, 2005 Key Record Dates |
| Last Update Posted: | March 6, 2017 |
| Last Verified: | March 2017 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
|
Zoledronic acid Zometa prostate cancer osteoporosis |
Additional relevant MeSH terms:
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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 |