A Study to Evaluate New or Worsening Lens Opacifications in Subjects With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss Due to Androgen-Deprivation Therapy
This study is currently recruiting participants.
Verified May 2013 by Amgen
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00925600
First received: June 18, 2009
Last updated: May 14, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new or worsening lens opacifications in subjects with non-metastatic prostate cancer receiving denosumab for bone loss due to androgen deprivation therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Cataract Low Bone Mineral Density Osteopenia Osteoporosis Prostate Cancer |
Biological: Denosumab Biological: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | A Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifications in Subjects With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss Due to Androgen-Deprivation Therapy |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Subject incidence of cataract event development or progression by month 12 exceeding a predefined level at any of 3 key lens locations using LOCS III score. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Subject incidence of cataract event development or progression by month 6 exceeding a predefined level at any of 3 key lens locations using LOCS III score. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
- Adverse event incidence and changes in safety analytes. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 760 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm A
Denosumab 60 mg subcutaneously on Day 1 and Month 6
|
Biological: Denosumab
Denosumab 60 mg is administered subcutaneously on Day 1 and Month 6.
|
|
Placebo Comparator: Arm B
Placebo subcutaneously on Day 1 and Month 6.
|
Biological: Placebo
Placebo administered subcutaneously on Day 1 and Month 6.
|
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men >=30 years of age with non-metastatic prostate cancer
- Have undergone bilateral orchiectomy or initiated ADT with GnRH agonists and is expected to continue on ADT for at least 12 months
- ECOG score (0,1 or 2)
- Baseline BCVA of 20/40, (6/12 or 0.5 on the decimal scale) or better using the ETDRS charts at 4 meters in one eye with a natural, intact lens
- Bone Mineral Density (BMD) requirements:
If <70 years: BMD T-score at the lumbar spine, total hip, or femoral neck >= -2.5 and <=-1.0 (osteopenia) If >= 70 years of age: BMD T-score at lumbar spine and total hip and femoral neck >= -2.5 At least 2 evaluable lumbar vertebrae
Exclusion Criteria:
- Screening LOCS III grade of >=3.5 for posterior subcapsular cataract, >= 4.0 for cortical cataract, or >= 4.5 for nuclear opalescence
- Bone Mineral Density (BMD) T-score< -2.5 at lumbar spine and/or total hip and/or femoral neck ("osteoporosis")
- evidence of distant metastases
- Known osteonecrosis of the jaw (ONJ)
- Unstable system disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization
- Incisional eye surgery in both eyes or cataract surgery in both eyes
- Current administration of IV bisphosphonates
- PSA > 5ng/mL at screening.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925600
Show 160 Study Locations
Contacts
| Contact: Amgen Call Center | 866-572-6436 |
Show 160 Study LocationsSponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00925600 History of Changes |
| Other Study ID Numbers: | 20080560 |
| Study First Received: | June 18, 2009 |
| Last Updated: | May 14, 2013 |
| Health Authority: | Czech Republic: Statni ustav pro kontrolu leciv EU: CHMP Euorpean Union: Ethics Committee European Union: European Medicines Agency France and Sweden: European Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: CCPPRB Central Ethics Committee France: CCTIRS: Advisory Committee on Medical research Data Processing Australia: Cabrini Human Research Ethics Committee Australia: Cancer Institute NSW Clinical Research Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: Eastern Health Research and Ethics Committee Australia: HREC Ballarat Health Services Australia: Human Research Ethics Committee Australia: Mater Health Service Human Research Ethics Committee France: Central EC, called Comite de Protection des Personnes France: CNIL: National Computers and Privacy Commission France: Ministry of Health France:CNOM: National Council of the French Medical Association Greece: National Ethics Committee Greece: National Organization for Medicines Hungary: Central Ethics Committee Hungary: National Institute of Pharmacy Australia: Royal Adelaide Hospital Research Ethics Committee Australia: Therapeutic Goods Administration Bulgaria: Bulgarian Drug Agency Bulgaria: Ministry of Health Canada: Health Canada Canada: Health Products and Food Branch Canada: Institutional Review Board Czech Republic: State Institute for Drug Control Latvia: State Agency of Medicines Mexico: COFEPRIS Mexico: Ministry of Health Mexico: SSA (Secretaria de Salud Publica) Poland: Drug Institut Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health Slovakia: Ministry of Health Slovakia: State Institiute for Drug Control Russia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health) Slovenia: Agency for Medicinal Products and Medicinal Devices of the Republic of Slovenia (ARSZMP) Slovenia: National Medical Ethics Committee (Komisija Republike Slovenije Za Medicinsko Etiko) South Africa: Department of Health United States: Food and Drug Administration United States: Institutional Review Board United States: IntegReview Ethical Review Board United States: MD Anderson Surveillance Committee FWA-363 United States: Quorom Institutional Review Board United States: Western Institutional Review Board Slovakia: Štátny ústav pre kontrolu lieciv |
Keywords provided by Amgen:
|
Lens Opacification Bone Loss Androgen Deprivation Therapy Non-metastatic prostate cancer |
Additional relevant MeSH terms:
|
Bone Diseases, Metabolic Osteoporosis Prostatic Neoplasms Cataract Bone Diseases Musculoskeletal Diseases Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Prostatic Diseases Lens Diseases Eye Diseases Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013