Clinical trial NCT00925600: Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Cataract
Low Bone Mineral Density
Osteopenia
Osteoporosis
Prostate Cancer
Keywords: Lens Opacification
Bone Loss
Androgen Deprivation Therapy
Non-metastatic prostate cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2009-06-22
Enrollment: 769
Sex: MALE
Minimum age (years): 30
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new or worsening lens opacifications in men with non-metastatic prostate cancer receiving denosumab for bone loss due to androgen deprivation therapy.


Eligibility criteria: Inclusion Criteria:

* Men ≥ 30 years of age with non-metastatic prostate cancer, having undergone bilateral orchiectomy or initiated androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (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

Primary outcomes:
measure: Percentage of Participants With Lens Opacification Event Development or Progression by Month 12
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Percentage of Participant With 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
timeFrame: 12 months
measure: Percentage of Participants With Lens Opacification Event Development or Progression by Month 6
timeFrame: 6 months
measure: Percentage of Participants With Confirmed Lens Opacification Event Development or Progression by Month 12
timeFrame: 12 months
measure: Percentage of Participants With a Decrease From Baseline in Best Corrected Visual Acuity (BCVA) of ≥ 10 Letters
timeFrame: Baseline and Months 3, 6, 9 and 12
measure: Change From Baseline in Refraction Needed to Achieve BCVA
timeFrame: Baseline and months 3, 6, 9, and 12
measure: Number of Participants With Adverse Events
timeFrame: 12 months
Locations:
city: Anaheim
country: United States
facility: Research Site
state: California
city: Laguna Hills
country: United States
facility: Research Site
state: California
city: Murrieta
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Luis Obispo
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Englewood
country: United States
facility: Research Site
state: Colorado
city: Middlebury
country: United States
facility: Research Site
state: Connecticut
city: New Britain
country: United States
facility: Research Site
state: Connecticut
city: Trinity
country: United States
facility: Research Site
state: Florida
city: Coeur d'Alene
country: United States
facility: Research Site
state: Idaho
city: Greenwood
country: United States
facility: Research Site
state: Indiana
city: West Des Moines
country: United States
facility: Research Site
state: Iowa
city: Kansas City
country: United States
facility: Research Site
state: Kansas
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Annapolis
country: United States
facility: Research Site
state: Maryland
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Greenbelt
country: United States
facility: Research Site
state: Maryland
city: Grand Rapids
country: United States
facility: Research Site
state: Michigan
city: Sartell
country: United States
facility: Research Site
state: Minnesota
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Missoula
country: United States
facility: Research Site
state: Montana
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Berlin
country: United States
facility: Research Site
state: New Jersey
city: Bricktown
country: United States
facility: Research Site
state: New Jersey
city: Englewood
country: United States
facility: Research Site
state: New Jersey
city: Lawrenceville
country: United States
facility: Research Site
state: New Jersey
city: Mount Laurel
country: United States
facility: Research Site
state: New Jersey
city: Albany
country: United States
facility: Research Site
state: New York
city: Garden City
country: United States
facility: Research Site
state: New York
city: Kingston
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Poughkeepsie
country: United States
facility: Research Site
state: New York
city: Syracuse
country: United States
facility: Research Site
state: New York
city: Gastonia
country: United States
facility: Research Site
state: North Carolina
city: Greenville
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Bala-Cynwyd
country: United States
facility: Research Site
state: Pennsylvania
city: Lancaster
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Research Site
state: South Carolina
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Temple
country: United States
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state: Texas
city: Richmond
country: United States
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state: Virginia
city: Salem
country: United States
facility: Research Site
state: Virginia
city: Wahroonga
country: Australia
facility: Research Site
state: New South Wales
city: Herston
country: Australia
facility: Research Site
state: Queensland
city: Bentleigh East
country: Australia
facility: Research Site
state: Victoria
city: Ringwood East
country: Australia
facility: Research Site
state: Victoria
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Kelowna
country: Canada
facility: Research Site
state: British Columbia
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Barrie
country: Canada
facility: Research Site
state: Ontario
city: Brampton
country: Canada
facility: Research Site
state: Ontario
city: Brantford
country: Canada
facility: Research Site
state: Ontario
city: Burlington
country: Canada
facility: Research Site
state: Ontario
city: Guelph
country: Canada
facility: Research Site
state: Ontario
city: Kitchener
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: North Bay
country: Canada
facility: Research Site
state: Ontario
city: North York
country: Canada
facility: Research Site
state: Ontario
city: Oakville
country: Canada
facility: Research Site
state: Ontario
city: Scarborough
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Laval
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Benesov
country: Czechia
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Hradec Kralove
country: Czechia
facility: Research Site
city: Jindrichuv Hradec
country: Czechia
facility: Research Site
city: Kromeriz
country: Czechia
facility: Research Site
city: Novy Jicin
country: Czechia
facility: Research Site
city: Olomouc
country: Czechia
facility: Research Site
city: Plzen
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Praha 6
country: Czechia
facility: Research Site
city: Usti nad Labem
country: Czechia
facility: Research Site
city: Zlin
country: Czechia
facility: Research Site
city: Lyon Cédex 3
country: France
facility: Research Site
city: Paris Cedex 5
country: France
facility: Research Site
city: Alexandroupoli
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Heraklion
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site
city: Patra
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Baja
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Ahmedabad
country: India
facility: Research Site
state: Gujarat
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Aurangabad
country: India
facility: Research Site
state: Maharashtra
city: Nashik
country: India
facility: Research Site
state: Maharashtra
city: Ludhiana
country: India
facility: Research Site
state: Punjab
city: Madurai
country: India
facility: Research Site
state: Tamil Nadu
city: Kolkata
country: India
facility: Research Site
state: West Bengal
city: Jelgava
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Distrito Federal
country: Mexico
facility: Research Site
city: Distrito Federal
country: Mexico
facility: Research Site
city: Christchurch
country: New Zealand
facility: Research Site
city: Takapuna, North Shore City
country: New Zealand
facility: Research Site
city: Tauranga
country: New Zealand
facility: Research Site
city: Whangarei
country: New Zealand
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Myslowice
country: Poland
facility: Research Site
city: Opole
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Rzeszow
country: Poland
facility: Research Site
city: Siedlce
country: Poland
facility: Research Site
city: Slupsk
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Ivanovo
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhny Novgorod
country: Russian Federation
facility: Research Site
city: Rostov-na-Donu
country: Russian Federation
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Martin
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Trencin
country: Slovakia
facility: Research Site
city: Celje
country: Slovenia
facility: Research Site
city: Ljubljana
country: Slovenia
facility: Research Site
city: Slovenj Gradec
country: Slovenia
facility: Research Site
city: Paarl
country: South Africa
facility: Research Site
state: Western Cape
city: George
country: South Africa
facility: Research Site
city: Kempton Park
country: South Africa
facility: Research Site
city: Port Elizabeth
country: South Africa
facility: Research Site
city: Tygerberg
country: South Africa
facility: Research Site
city: Chernivtsi
country: Ukraine
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Uzhgorod
country: Ukraine
facility: Research Site
city: Zaporizhzhya
country: Ukraine
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: