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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

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer; Cataract; Low Bone Mineral Density; Osteopenia; Osteoporosis; Prostate Cancer

Intervention: Denosumab (Biological); Placebo (Biological)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: 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.

Eligibility

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

Research Site, Pleven 5800, Bulgaria

Research Site, Plovdiv 4004, Bulgaria

Research Site, Sofia 1784, Bulgaria

Research Site, Benesov 256 01, Czech Republic

Research Site, Brno 612 00, Czech Republic

Research Site, Hradec Kralove 500 05, Czech Republic

Research Site, Jindrichuv Hradec 377 01, Czech Republic

Research Site, Kromeriz 767 55, Czech Republic

Research Site, Novy Jicin 741 01, Czech Republic

Research Site, Olomouc 775 20, Czech Republic

Research Site, Plzen 305 99, Czech Republic

Research Site, Praha 2 120 00, Czech Republic

Research Site, Praha 4 140 00, Czech Republic

Research Site, Praha 6 160 00, Czech Republic

Research Site, Usti nad Labem 401 13, Czech Republic

Research Site, Zlin 760 01, Czech Republic

Research Site, Lyon Cédex 3 69437, France

Research Site, Paris Cedex 5 75248, France

Research Site, Alexandroupoli 68100, Greece

Research Site, Athens 11527, Greece

Research Site, Athens 11522, Greece

Research Site, Athens 11526, Greece

Research Site, Heraklion 71110, Greece

Research Site, Larissa 41110, Greece

Research Site, Patra 26504, Greece

Research Site, Thessaloniki 56429, Greece

Research Site, Thessaloniki 54622, Greece

Research Site, Baja 6500, Hungary

Research Site, Budapest 1036, Hungary

Research Site, Budapest 1082, Hungary

Research Site, Budapest 1204, Hungary

Research Site, Gyor 9023, Hungary

Research Site, Miskolc 3526, Hungary

Research Site, Nyiregyhaza 4400, Hungary

Research Site, Szeged 6722, Hungary

Research Site, Jelgava 3001, Latvia

Research Site, Riga 1002, Latvia

Research Site, Riga 1079, Latvia

Research Site, Distrito Federal 01120, Mexico

Research Site, Distrito Federal 11950, Mexico

Research Site, Christchurch 8013, New Zealand

Research Site, Takapuna, North Shore City 0622, New Zealand

Research Site, Tauranga 3112, New Zealand

Research Site, Whangarei 0112, New Zealand

Research Site, Gdansk 80-952, Poland

Research Site, Gdansk 80-180, Poland

Research Site, Gdynia 81-366, Poland

Research Site, Gdynia 81-423, Poland

Research Site, Katowice 40-857, Poland

Research Site, Myslowice 41-400, Poland

Research Site, Opole 45-086, Poland

Research Site, Poznan 61-866, Poland

Research Site, Rzeszow 35-021, Poland

Research Site, Siedlce 08-110, Poland

Research Site, Slupsk 76-200, Poland

Research Site, Szczecin 70-111, Poland

Research Site, Warszawa 00-631, Poland

Research Site, Warszawa 02-005, Poland

Research Site, Warszawa 02-781, Poland

Research Site, Wroclaw 50-044, Poland

Research Site, Ivanovo 153013, Russian Federation

Research Site, Moscow 105425, Russian Federation

Research Site, Moscow 115478, Russian Federation

Research Site, Moscow 125284, Russian Federation

Research Site, Nizhny Novgorod 603126, Russian Federation

Research Site, Rostov-na-Donu 344022, Russian Federation

Research Site, Bratislava 851 05, Slovakia

Research Site, Kosice 040 01, Slovakia

Research Site, Kosice 040 11, Slovakia

Research Site, Kosice 040 23, Slovakia

Research Site, Martin 036 59, Slovakia

Research Site, Nitra 949 01, Slovakia

Research Site, Trencin 911 01, Slovakia

Research Site, Celje 3000, Slovenia

Research Site, Ljubljana 1525, Slovenia

Research Site, Slovenj Gradec 2380, Slovenia

Research Site, George 6530, South Africa

Research Site, Kempton Park 1619, South Africa

Research Site, Port Elizabeth 6001, South Africa

Research Site, Tygerberg 7505, South Africa

Research Site, Chernivtsi 58002, Ukraine

Research Site, Dnipropetrovsk 49005, Ukraine

Research Site, Kharkiv 61037, Ukraine

Research Site, Kyiv 02125, Ukraine

Research Site, Uzhgorod 88000, Ukraine

Research Site, Zaporizhzhya 69600, Ukraine

Research Site, Kelowna, British Columbia V1W 4V5, Canada

Research Site, Vancouver, British Columbia V5Z 1M9, Canada

Research Site, Victoria, British Columbia V8T 5G1, Canada

Research Site, Victoria, British Columbia V8V 3N1, Canada

Research Site, Anaheim, California 92801, United States

Research Site, Laguna Hills, California 92653, United States

Research Site, Murrieta, California 92562, United States

Research Site, San Diego, California 92103, United States

Research Site, San Diego, California 92120, United States

Research Site, San Diego, California 92123, United States

Research Site, San Luis Obispo, California 93405, United States

Research Site, Denver, Colorado 80204, United States

Research Site, Denver, Colorado 80211, United States

Research Site, Englewood, Colorado 80113, United States

Research Site, Middlebury, Connecticut 06762, United States

Research Site, New Britain, Connecticut 06052, United States

Research Site, Trinity, Florida 34655, United States

Research Site, Ahmedabad, Gujarat 380 009, India

Research Site, Coeur d'Alene, Idaho 83814, United States

Research Site, Greenwood, Indiana 46143, United States

Research Site, West Des Moines, Iowa 50266, United States

Research Site, Kansas City, Kansas 66160, United States

Research Site, Bangalore, Karnataka 560 027, India

Research Site, Shreveport, Louisiana 71106, United States

Research Site, Aurangabad, Maharashtra 431 005, India

Research Site, Nashik, Maharashtra 422 004, India

Research Site, Annapolis, Maryland 21401, United States

Research Site, Baltimore, Maryland 21201, United States

Research Site, Greenbelt, Maryland 20770, United States

Research Site, Grand Rapids, Michigan 49546, United States

Research Site, Sartell, Minnesota 56377, United States

Research Site, St Louis, Missouri 63110, United States

Research Site, Missoula, Montana 59808, United States

Research Site, Omaha, Nebraska 68105-1850, United States

Research Site, Omaha, Nebraska 68130, United States

Research Site, Berlin, New Jersey 08009, United States

Research Site, Brick, New Jersey 08724, United States

Research Site, Englewood, New Jersey 07631, United States

Research Site, Lawrenceville, New Jersey 08648, United States

Research Site, Mount Laurel, New Jersey 08054, United States

Research Site, Wahroonga, New South Wales 2076, Australia

Research Site, Albany, New York 12208, United States

Research Site, Garden City, New York 11530, United States

Research Site, Kingston, New York 12401, United States

Research Site, New York, New York 10021, United States

Research Site, Poughkeepsie, New York 12601, United States

Research Site, Syracuse, New York 13210, United States

Research Site, Gastonia, North Carolina 28054, United States

Research Site, Greenville, North Carolina 27834, United States

Research Site, Halifax, Nova Scotia B3H 2Y9, Canada

Research Site, Cincinnati, Ohio 45212, United States

Research Site, Barrie, Ontario L4M 7G1, Canada

Research Site, Brampton, Ontario L6T 4S5, Canada

Research Site, Brantford, Ontario N3S 6T6, Canada

Research Site, Burlington, Ontario L7N 3V2, Canada

Research Site, Guelph, Ontario N1H 5J1, Canada

Research Site, Kitchener, Ontario N2N 2B9, Canada

Research Site, London, Ontario N6A 4G5, Canada

Research Site, Newmarket, Ontario L3X 1W1, Canada

Research Site, North Bay, Ontario P1B 7K8, Canada

Research Site, North York, Ontario M3B 3S6, Canada

Research Site, Oakville, Ontario L6H 3P1, Canada

Research Site, Scarborough, Ontario M1P 2T7, Canada

Research Site, Toronto, Ontario M4N 3M5, Canada

Research Site, Toronto, Ontario M5G 2M9, Canada

Research Site, Toronto, Ontario M6A 3B5, Canada

Research Site, Bala Cynwyd, Pennsylvania 19004, United States

Research Site, Lancaster, Pennsylvania 17604, United States

Research Site, Philadelphia, Pennsylvania 19107, United States

Research Site, Ludhiana, Punjab 141 008, India

Research Site, Laval, Quebec H7G 2E6, Canada

Research Site, Montreal, Quebec H2L 4M1, Canada

Research Site, Herston, Queensland 4029, Australia

Research Site, Myrtle Beach, South Carolina 29572, United States

Research Site, Madurai, Tamil Nadu 625 107, India

Research Site, Knoxville, Tennessee 37920, United States

Research Site, Austin, Texas 78759, United States

Research Site, Dallas, Texas 75231, United States

Research Site, San Antonio, Texas 78229, United States

Research Site, Temple, Texas 76508, United States

Research Site, Bentleigh East, Victoria 3165, Australia

Research Site, Ringwood East, Victoria 3135, Australia

Research Site, Richmond, Virginia 23235, United States

Research Site, Salem, Virginia 24153, United States

Research Site, Kolkata, West Bengal 700 027, India

Research Site, Paarl, Western Cape 7646, South Africa

Additional Information

AmgenTrials clinical trials website

Starting date: November 2009
Last updated: June 25, 2015

Page last updated: August 23, 2015

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