Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss
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
2 other identifiers
interventional
769
17 countries
169
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 cancer
Started Nov 2009
Longer than P75 for phase_3 cancer
169 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2009
CompletedFirst Posted
Study publicly available on registry
June 22, 2009
CompletedStudy Start
First participant enrolled
November 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2016
CompletedResults Posted
Study results publicly available
May 30, 2017
CompletedMay 30, 2017
April 1, 2017
6.5 years
June 18, 2009
April 19, 2017
April 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Lens Opacification Event Development or Progression by Month 12
The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity. Lens opacification event development or progression by month 12 was based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score from baseline.
12 months
Other Outcomes (6)
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
12 months
Percentage of Participants With Lens Opacification Event Development or Progression by Month 6
6 months
Percentage of Participants With Confirmed Lens Opacification Event Development or Progression by Month 12
12 months
- +3 more other outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
Denosumab
EXPERIMENTALParticipants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (172)
Research Site
Anaheim, California, 92801, United States
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Laguna Hills, California, 92653, United States
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Murrieta, California, 92562, United States
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San Diego, California, 92103, United States
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San Diego, California, 92120, United States
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San Diego, California, 92123, United States
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San Luis Obispo, California, 93405, United States
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Denver, Colorado, 80204, United States
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Denver, Colorado, 80211, United States
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Englewood, Colorado, 80113, United States
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Middlebury, Connecticut, 06762, United States
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New Britain, Connecticut, 06052, United States
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Trinity, Florida, 34655, United States
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Coeur d'Alene, Idaho, 83814, United States
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Greenwood, Indiana, 46143, United States
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West Des Moines, Iowa, 50266, United States
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Kansas City, Kansas, 66160, United States
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Shreveport, Louisiana, 71106, United States
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Annapolis, Maryland, 21401, United States
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Baltimore, Maryland, 21201, United States
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Greenbelt, Maryland, 20770, United States
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Grand Rapids, Michigan, 49546, United States
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Sartell, Minnesota, 56377, United States
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St Louis, Missouri, 63110, United States
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Missoula, Montana, 59808, United States
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Omaha, Nebraska, 68105-1850, United States
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Omaha, Nebraska, 68130, United States
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Berlin, New Jersey, 08009, United States
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Brick, New Jersey, 08724, United States
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Englewood, New Jersey, 07631, United States
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Lawrenceville, New Jersey, 08648, United States
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Mount Laurel, New Jersey, 08054, United States
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Albany, New York, 12208, United States
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Garden City, New York, 11530, United States
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Kingston, New York, 12401, United States
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New York, New York, 10021, United States
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Poughkeepsie, New York, 12601, United States
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Syracuse, New York, 13210, United States
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Gastonia, North Carolina, 28054, United States
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Greenville, North Carolina, 27834, United States
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Cincinnati, Ohio, 45212, United States
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Bala-Cynwyd, Pennsylvania, 19004, United States
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Lancaster, Pennsylvania, 17604, United States
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Philadelphia, Pennsylvania, 19107, United States
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Myrtle Beach, South Carolina, 29572, United States
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Knoxville, Tennessee, 37920, United States
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Austin, Texas, 78759, United States
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Dallas, Texas, 75231, United States
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San Antonio, Texas, 78229, United States
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Temple, Texas, 76508, United States
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Richmond, Virginia, 23235, United States
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Salem, Virginia, 24153, United States
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Wahroonga, New South Wales, 2076, Australia
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Herston, Queensland, 4029, Australia
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Bentleigh East, Victoria, 3165, Australia
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Ringwood East, Victoria, 3135, Australia
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Pleven, 5800, Bulgaria
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Plovdiv, 4004, Bulgaria
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Sofia, 1784, Bulgaria
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Kelowna, British Columbia, V1W 4V5, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Victoria, British Columbia, V8T 5G1, Canada
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Victoria, British Columbia, V8V 3N1, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Barrie, Ontario, L4M 7G1, Canada
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Brampton, Ontario, L6T 4S5, Canada
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Brantford, Ontario, N3S 6T6, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Guelph, Ontario, N1H 5J1, Canada
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Kitchener, Ontario, N2N 2B9, Canada
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London, Ontario, N6A 4G5, Canada
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Newmarket, Ontario, L3X 1W1, Canada
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North Bay, Ontario, P1B 7K8, Canada
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North York, Ontario, M3B 3S6, Canada
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Oakville, Ontario, L6H 3P1, Canada
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Scarborough Village, Ontario, M1P 2T7, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Toronto, Ontario, M6A 3B5, Canada
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Laval, Quebec, H7G 2E6, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Benešov, 256 01, Czechia
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Brno, 612 00, Czechia
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Hradec Králové, 500 05, Czechia
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Jindřichův Hradec, 377 01, Czechia
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Kroměříž, 767 55, Czechia
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Nový Jičín, 741 01, Czechia
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Olomouc, 775 20, Czechia
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Pilsen, 305 99, Czechia
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Prague, 120 00, Czechia
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Prague, 140 00, Czechia
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Prague, 160 00, Czechia
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Ústí nad Labem, 401 13, Czechia
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Zlín, 760 01, Czechia
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Lyon Cédex 3, 69437, France
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Paris, 75248, France
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Alexandroupoli, 68100, Greece
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Athens, 11522, Greece
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Athens, 11526, Greece
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Athens, 11527, Greece
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Heraklion, 71110, Greece
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Larissa, 41110, Greece
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Pátrai, 26504, Greece
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Thessaloniki, 54622, Greece
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Thessaloniki, 56429, Greece
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Baja, 6500, Hungary
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Budapest, 1036, Hungary
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Budapest, 1082, Hungary
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Budapest, 1204, Hungary
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Győr, 9023, Hungary
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Miskolc, 3526, Hungary
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Nyíregyháza, 4400, Hungary
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Szeged, 6722, Hungary
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Ahmedabad, Gujarat, 380 009, India
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Bangalore, Karnataka, 560 027, India
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Aurangabad, Maharashtra, 431 005, India
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Nashik, Maharashtra, 422 004, India
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Ludhiana, Punjab, 141 008, India
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Madurai, Tamil Nadu, 625 107, India
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Kolkata, West Bengal, 700 027, India
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Jelgava, 3001, Latvia
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Riga, 1002, Latvia
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Riga, 1079, Latvia
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Distrito Federal, 01120, Mexico
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Distrito Federal, 11950, Mexico
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Christchurch, 8013, New Zealand
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Takapuna, North Shore City, 0622, New Zealand
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Tauranga, 3112, New Zealand
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Whangarei, 0112, New Zealand
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Gdansk, 80-180, Poland
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Gdansk, 80-952, Poland
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Gdynia, 81-366, Poland
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Gdynia, 81-423, Poland
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Katowice, 40-857, Poland
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Mysłowice, 41-400, Poland
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Opole, 45-086, Poland
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Poznan, 61-866, Poland
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Rzeszów, 35-021, Poland
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Siedlce, 08-110, Poland
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Szczecin, 70-111, Poland
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Słupsk, 76-200, Poland
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Warsaw, 00-631, Poland
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Warsaw, 02-005, Poland
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Warsaw, 02-781, Poland
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Wroclaw, 50-044, Poland
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Ivanovo, 153013, Russia
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Moscow, 105425, Russia
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Moscow, 115478, Russia
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Moscow, 125284, Russia
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Nizhny Novgorod, 603126, Russia
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Rostov-on-Don, 344022, Russia
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Bratislava, 851 05, Slovakia
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Košice, 040 01, Slovakia
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Košice, 040 11, Slovakia
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Košice, 040 23, Slovakia
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Martin, 036 59, Slovakia
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Nitra, 949 01, Slovakia
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Trenčín, 911 01, Slovakia
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Celje, 3000, Slovenia
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Ljubljana, 1525, Slovenia
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Slovenj Gradec, 2380, Slovenia
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Paarl, Western Cape, 7646, South Africa
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George, 6530, South Africa
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Kempton Park, 1619, South Africa
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Port Elizabeth, 6001, South Africa
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Tygerberg, 7505, South Africa
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Chernivtsi, 58002, Ukraine
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Dnipropetrovsk, 49005, Ukraine
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Kharkiv, 61037, Ukraine
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Kyiv, 02125, Ukraine
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Uzhhorod, 88000, Ukraine
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Zaporizhzhya, 69600, Ukraine
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2009
First Posted
June 22, 2009
Study Start
November 30, 2009
Primary Completion
May 12, 2016
Study Completion
May 12, 2016
Last Updated
May 30, 2017
Results First Posted
May 30, 2017
Record last verified: 2017-04