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. (see Contacts and Locations)
Verified July 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00925600
First received: June 18, 2009
Last updated: July 30, 2014
Last verified: July 2014
  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 lens opacification event development or progression by month 12, based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Lens opacification event development or progression


Other Outcome Measures:
  • Subject incidence of lens opacification event development or progression by month 12, based on a change of ≥ 1.5 in P, ≥ 1.5 in C, or ≥ 1.5 in NO in the LOCS III score. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Lens opacification event development or progression

  • Subject incidence of lens opacification event development or progression by month 6, based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Lens opacification event development or progression.

  • Subject incidence of a decrease from baseline BCVA as measured by a change of ≥ 10 letters on the ETDRS at 4 meters, at months, 3, 6, 9, and 12. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Incidence of decreased best corrected visual acuity (BCVA)

  • Change in refraction needed to achieve BCVA at 3, 6, 9, and 12 as measured by change in sphere [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Change in refraction needed to achieve BCVA

  • Adverse event incidence, serious adverse event incidence, changes in safety laboratory analytes (ie, serum chemistry). [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Safety as measured by adverse events and safety laboratory parameters

  • Subject incidence of confirmed lens opacification event development or progression by month 12, based on a change of ≥1.0 in P, ≥1.0 in C, or ≥0.7 in NO in the LOCSIII score. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Confirmed lens opacification event development or progression. A confirmed lens opacification event development or progression is defined as 2 directly subsequent events per protocol assessments at the same location (P,C,NO) using LOCIII as above.


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, having undergone bilateral orchiectomy or initiated ADT with GnRH agonists and is expected to continue on ADT for at least 12 months
  • Adequate visual accuracy allowing eye testing
  • Bone Mineral Density (BMD) requirements: Osteopenia if under 70 years of age; Osteopenia or normal BMD if over 70 years of age
  • Signed informed consent

Exclusion Criteria:

  • Previous surgery for cataracts in both eyes, current diagnosis of cataracts, cataracts surgery foreseen in the near future, or ocular disease leading to visual loss
  • Diagnosis of osteoporosis
  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: NCT00925600

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 171 Study Locations
Sponsors 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: July 30, 2014
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
Ukraine: Ministry of Health

Keywords provided by Amgen:
Lens Opacification
Bone Loss
Androgen Deprivation Therapy
Non-metastatic prostate cancer

Additional relevant MeSH terms:
Prostatic Diseases
Osteoporosis
Prostatic Neoplasms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014