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Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss

Primary Purpose

Cancer, Cataract, Low Bone Mineral Density

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Denosumab
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Lens Opacification, Bone Loss, Androgen Deprivation Therapy, Non-metastatic prostate cancer

Eligibility Criteria

30 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Denosumab

Arm Description

Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.

Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 18, 2009
Last Updated
April 19, 2017
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT00925600
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 30, 2009 (Actual)
Primary Completion Date
May 12, 2016 (Actual)
Study Completion Date
May 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Cataract, Low Bone Mineral Density, Osteopenia, Osteoporosis, Prostate Cancer
Keywords
Lens Opacification, Bone Loss, Androgen Deprivation Therapy, Non-metastatic prostate cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
769 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
Arm Title
Denosumab
Arm Type
Experimental
Arm Description
Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
Intervention Type
Biological
Intervention Name(s)
Denosumab
Other Intervention Name(s)
Prolia®
Intervention Description
Prefilled syringe for subcutaneous (SC) injection administered at a dose of 60 mg
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Prefilled syringe for subcutaneous (SC) injection
Primary Outcome Measure Information:
Title
Percentage of Participants With Lens Opacification Event Development or Progression by Month 12
Description
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.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
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
Description
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 ≥ 1.5 in P, ≥ 1.5 in C, or ≥ 1.5 in NO in the LOCS III score from baseline.
Time Frame
12 months
Title
Percentage of Participants With Lens Opacification Event Development or Progression by Month 6
Description
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 6 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.
Time Frame
6 months
Title
Percentage of Participants With Confirmed Lens Opacification Event Development or Progression by Month 12
Description
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. A confirmed lens opacification event development or progression was defined as 2 directly subsequent events per protocol assessments at the same location (P, C, NO) using LOCS III as above.
Time Frame
12 months
Title
Percentage of Participants With a Decrease From Baseline in Best Corrected Visual Acuity (BCVA) of ≥ 10 Letters
Description
The best corrected visual acuity (BCVA) is the best vision one can achieve with correction (such as eye glasses) as measured on an eye chart. BCVA was assessed by a trained ophthalmologist using the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at 4 meters. The modified University of Crete ETDRS chart was used in Ukraine, Greece, Russia and Bulgaria, which do not use the Roman alphabet. The 2000 series revised ETDRS chart was used to assess the change in all other countries. The letter score was calculated based on the number of letters that were correctly identified; higher letter scores correspond to better visual acuity.
Time Frame
Baseline and Months 3, 6, 9 and 12
Title
Change From Baseline in Refraction Needed to Achieve BCVA
Description
Refraction error was measured using a phoropter. The change from baseline in spherical refraction error needed to achieve BCVA is reported.
Time Frame
Baseline and months 3, 6, 9, and 12
Title
Number of Participants With Adverse Events
Description
Adverse events (AEs) were assessed for severity by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) severity grading scale, version 3.0, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 =Life-threatening AE and Grade 5 = Death due to AE. Treatment-related AEs (TRAEs) include only events for which the investigator indicated there was a reasonable possibility they may have been caused by the study drug.
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Research Site
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Research Site
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Research Site
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Research Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Research Site
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
Research Site
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
Research Site
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Research Site
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Research Site
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
Country
United States
Facility Name
Research Site
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
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United States
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Research Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Research Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
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Research Site
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Research Site
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
Research Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
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United States
Facility Name
Research Site
City
Sartell
State/Province
Minnesota
ZIP/Postal Code
56377
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Research Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105-1850
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Research Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Research Site
City
Bricktown
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
Research Site
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Research Site
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Research Site
City
Mount Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Facility Name
Research Site
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Research Site
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Research Site
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Research Site
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Research Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Research Site
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Research Site
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Research Site
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Research Site
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Research Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Research Site
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Research Site
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
Research Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Research Site
City
Bentleigh East
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Research Site
City
Ringwood East
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
Facility Name
Research Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Research Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1W 4V5
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Research Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G1
Country
Canada
Facility Name
Research Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3N1
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Research Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Research Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 4S5
Country
Canada
Facility Name
Research Site
City
Brantford
State/Province
Ontario
ZIP/Postal Code
N3S 6T6
Country
Canada
Facility Name
Research Site
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7N 3V2
Country
Canada
Facility Name
Research Site
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1H 5J1
Country
Canada
Facility Name
Research Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N 2B9
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Research Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3X 1W1
Country
Canada
Facility Name
Research Site
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 7K8
Country
Canada
Facility Name
Research Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M3B 3S6
Country
Canada
Facility Name
Research Site
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada
Facility Name
Research Site
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1P 2T7
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 3B5
Country
Canada
Facility Name
Research Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7G 2E6
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Research Site
City
Benesov
ZIP/Postal Code
256 01
Country
Czechia
Facility Name
Research Site
City
Brno
ZIP/Postal Code
612 00
Country
Czechia
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Research Site
City
Jindrichuv Hradec
ZIP/Postal Code
377 01
Country
Czechia
Facility Name
Research Site
City
Kromeriz
ZIP/Postal Code
767 55
Country
Czechia
Facility Name
Research Site
City
Novy Jicin
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Research Site
City
Plzen
ZIP/Postal Code
305 99
Country
Czechia
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Research Site
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Research Site
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Research Site
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Research Site
City
Lyon Cédex 3
ZIP/Postal Code
69437
Country
France
Facility Name
Research Site
City
Paris Cedex 5
ZIP/Postal Code
75248
Country
France
Facility Name
Research Site
City
Alexandroupoli
ZIP/Postal Code
68100
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11522
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11526
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Research Site
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
Research Site
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Research Site
City
Patra
ZIP/Postal Code
26504
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
54622
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Research Site
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Research Site
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Research Site
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Research Site
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
6722
Country
Hungary
Facility Name
Research Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380 009
Country
India
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 027
Country
India
Facility Name
Research Site
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431 005
Country
India
Facility Name
Research Site
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422 004
Country
India
Facility Name
Research Site
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141 008
Country
India
Facility Name
Research Site
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625 107
Country
India
Facility Name
Research Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700 027
Country
India
Facility Name
Research Site
City
Jelgava
ZIP/Postal Code
3001
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1079
Country
Latvia
Facility Name
Research Site
City
Distrito Federal
ZIP/Postal Code
01120
Country
Mexico
Facility Name
Research Site
City
Distrito Federal
ZIP/Postal Code
11950
Country
Mexico
Facility Name
Research Site
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
Facility Name
Research Site
City
Takapuna, North Shore City
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Research Site
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Research Site
City
Whangarei
ZIP/Postal Code
0112
Country
New Zealand
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-180
Country
Poland
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Research Site
City
Gdynia
ZIP/Postal Code
81-366
Country
Poland
Facility Name
Research Site
City
Gdynia
ZIP/Postal Code
81-423
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-857
Country
Poland
Facility Name
Research Site
City
Myslowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Research Site
City
Opole
ZIP/Postal Code
45-086
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
Research Site
City
Rzeszow
ZIP/Postal Code
35-021
Country
Poland
Facility Name
Research Site
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Facility Name
Research Site
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Research Site
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
00-631
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-005
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-044
Country
Poland
Facility Name
Research Site
City
Ivanovo
ZIP/Postal Code
153013
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
105425
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Research Site
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Research Site
City
Rostov-na-Donu
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Research Site
City
Bratislava
ZIP/Postal Code
851 05
Country
Slovakia
Facility Name
Research Site
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
Research Site
City
Kosice
ZIP/Postal Code
040 11
Country
Slovakia
Facility Name
Research Site
City
Kosice
ZIP/Postal Code
040 23
Country
Slovakia
Facility Name
Research Site
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
Research Site
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Research Site
City
Trencin
ZIP/Postal Code
911 01
Country
Slovakia
Facility Name
Research Site
City
Celje
ZIP/Postal Code
3000
Country
Slovenia
Facility Name
Research Site
City
Ljubljana
ZIP/Postal Code
1525
Country
Slovenia
Facility Name
Research Site
City
Slovenj Gradec
ZIP/Postal Code
2380
Country
Slovenia
Facility Name
Research Site
City
Paarl
State/Province
Western Cape
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Research Site
City
George
ZIP/Postal Code
6530
Country
South Africa
Facility Name
Research Site
City
Kempton Park
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Research Site
City
Port Elizabeth
ZIP/Postal Code
6001
Country
South Africa
Facility Name
Research Site
City
Tygerberg
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Research Site
City
Chernivtsi
ZIP/Postal Code
58002
Country
Ukraine
Facility Name
Research Site
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
02125
Country
Ukraine
Facility Name
Research Site
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Research Site
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss

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