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 - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00925600

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 III

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:

MedlinePlus related topics: Cancer Cataract Osteoporosis Prostate Cancer

Drug Information available for: Denosumab

U.S. FDA Resources

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:	February 2014
Estimated Primary Completion Date:	December 2012 (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 adminstered subcutaneously on Day 1 and Month 6.
Placebo Comparator: Arm B Placebo subcutaneously on Day 1 and Month 6.	Biological: Placebo Placebo adminstered 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

Contacts

Contact: Amgen Call Center

866-572-6436

Show 130 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00925600 History of Changes
Other Study ID Numbers:	20080560
Study First Received:	June 18, 2009
Last Updated:	January 18, 2012
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 - French Health Products Safety Agency; 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 February 09, 2012