Double-blind Study of Denosumab Compared With Zoledronic Acid in the Treatment of Bone Metastases in Men With Hormone-refractory Prostate Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Amgen.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00321620
First received: May 2, 2006
Last updated: November 24, 2010
Last verified: November 2010
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Purpose
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Bone Metastases |
Drug: zoledronic acid Biological: denosumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Time to the first on-study SRE (non-inferiority) [ Time Frame: Onset of event for 745 subjects ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to the first on-study SRE (superiority) [ Time Frame: Onset of event for 745 subjects ] [ Designated as safety issue: No ]
- Time to the first-and-subsequent on-study SRE (superiority, using multiple event analysis) [ Time Frame: Onset of first and subsequent event ] [ Designated as safety issue: No ]
- Subject incidence of treatment-emergent adverse events [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
- Changes in laboratory values [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
- Incidence of anti-denosumab antibody (binding and neutralizing) formation [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
| Enrollment: | 1904 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | March 2012 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: denosumab placebo with active zoledronic acid |
Drug: zoledronic acid
4mg zoledronic acid IV over minimum 15 minutes Q4W
Other Name: Zometa
|
| Active Comparator: denosumab with zoledronic acid placebo |
Biological: denosumab
120 mg SC Q4W
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men >/= 18 years of age with histologically confirmed prostate cancer
- Radiographic evidence of at least one bone metastasis
- Failure of at least one hormonal therapy as evidenced by a rising PSA
- Serum testosterone level of <50 ng/dL
- ECOG PS 0, 1, or 2
- Adequate organ function
Exclusion Criteria:
- Current or prior IV bisphosphonate administration
- Current or prior oral bisphosphonates for bone mets
- Life expectancy of less than 6 months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321620
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| Zilina, Slovakia | |
| South Africa | |
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| Durban, Kwazulu-Natal, South Africa | |
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| Cape Town, South Africa | |
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| Johannesburg, South Africa | |
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| Pretoria, South Africa | |
| Spain | |
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| A Coruña, Galicia, Spain | |
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| Pamplona, Navarra, Spain | |
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| Barcelona, Spain | |
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| Madrid, Spain | |
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| Salamanca, Spain | |
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| Valencia, Spain | |
| Sweden | |
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| Malmö, Sweden | |
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| Uppsala, Sweden | |
| Switzerland | |
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| Aarau, Switzerland | |
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| Bern, Switzerland | |
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| Geneva 14, Switzerland | |
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| Zurich, Switzerland | |
| Turkey | |
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| Ankara, Turkey | |
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| Istanbul, Turkey | |
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| Izmir, Turkey | |
| Ukraine | |
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| Chernivtsi, Ukraine | |
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| Ivano-Frankivsk, Ukraine | |
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| Kharkiv, Ukraine | |
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| Kherson, Ukraine | |
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| Lugansk, Ukraine | |
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| Uzhgorod, Ukraine | |
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| Zaporizhzya, Ukraine | |
| United Kingdom | |
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| Bath, United Kingdom | |
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| Birmingham, United Kingdom | |
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| Cambridge, United Kingdom | |
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| Chichester, United Kingdom | |
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| Leeds, United Kingdom | |
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| London, United Kingdom | |
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| Northwood, United Kingdom | |
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| Nottingham, United Kingdom | |
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| Sheffield, United Kingdom | |
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| York, United Kingdom | |
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided by Amgen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00321620 History of Changes |
| Other Study ID Numbers: | 20050103 |
| Study First Received: | May 2, 2006 |
| Last Updated: | November 24, 2010 |
| Health Authority: | Latvia: State Agency of Medicines Lithuania: Ministry of Health Mexico: Ministry of Health Netherlands: Medicines Evaluation Board Norway: Norwegian Medicines Agency Panama: Ministry of Health, Peru: Ministry of Health Poland: Drug Institut Portugal: National Institute of Pharmacy and Medicines Romania: Ministry of Health and the Family Russia: Ministry of Health Slovakia: Ministry of Health South Africa: Department of Health Spain: Spanish Drug Agency Sweden: Medical Products Agency Switzerland: Agency for Therapeutic Products Turkey: Ministry of Health Ukraine: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration Argentina: Ministry of Health Australia: Therapeutic Goods Administration Austria: Secretariat of Health Belgium: Pharmaceutical Inspectorate Brazil: Ministry of Health Bulgaria: Ministry of Health Canada: Health Products and Food Branch Chile: Health Ministry Czech Republic: State Institute for Drug Control Denmark: Ministry of Health Estonia: State Agency of Medicines France: Ministry of Health Germancy: Federal Institute for Drugs and Medical Devices Greece: National Organization for Medicines Guatemala: Ministry of Health Hungary: Ministry of Health, Social and Family Affairs Israel: Ministry of Health Italy: Ministry of Health |
Keywords provided by Amgen:
|
Bone metastases Hormone-refractory prostate cancer Skeletal |
Fractures Compressions Bisphosphonates |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms, Second Primary Prostatic Neoplasms Bone Neoplasms Bone Marrow Diseases Neoplastic Processes Neoplasms Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male |
Prostatic Diseases Bone Diseases Musculoskeletal Diseases Hematologic Diseases Hormones Zoledronic acid Diphosphonates Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 21, 2013