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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00925600
First Posted: June 22, 2009
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
Results First Submitted: April 19, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Cancer
Cataract
Low Bone Mineral Density
Osteopenia
Osteoporosis
Prostate Cancer
Interventions: Biological: Denosumab
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

This study was conducted at 125 centers in 18 countries: Australia, Bulgaria, Canada, the Czech Republic, France, Greece, Hungary, India, Latvia, Mexico, New Zealand, Poland, Russia, Slovakia, Slovenia, South Africa, Ukraine, and the United States.

The first participant enrolled on 30 November 2009 and the last participant enrolled on 04 May 2015.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomly assigned to receive denosumab or placebo in a 1:1 allocation ratio. Randomization was stratified on the basis of screening Lens Opacities Classification System (LOCS) III status (< 3.0 at all sites versus ≥ 3.0 at any site); age group (< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).

Reporting Groups
  Description
Placebo Participants randomized to receive placebo administered by subcutaneous injection on Day 1 and at Month 6.
Denosumab Participants randomized to receive denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.

Participant Flow:   Overall Study
    Placebo   Denosumab
STARTED   386   383 
Received Treatment   383 [1]   382 
COMPLETED   354   355 
NOT COMPLETED   32   28 
Withdrawal by Subject                16                14 
Death                4                3 
Lost to Follow-up                2                2 
Disease Progression                1                3 
Administrative Decision                1                1 
Noncompliance                2                0 
Ineligibility Determined                2                0 
Protocol Deviation                0                1 
Requirement for Alternative Therapy                0                1 
Other                3                1 
Adverse Event                1                2 
[1] Three participants received at least 1 dose of denosumab in error



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Placebo Participants randomized to receive placebo administered by subcutaneous injection on Day 1 and at Month 6.
Denosumab Participants randomized to receive denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
Total Total of all reporting groups

Baseline Measures
   Placebo   Denosumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 386   383   769 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.0  (7.0)   71.1  (7.2)   71.0  (7.1) 
Age, Customized 
[Units: Participants]
     
18 - 64 years   73   66   139 
65 - 74 years   189   194   383 
75 - 84 years   119   116   235 
≥ 85 years   5   7   12 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      386 100.0%      383 100.0%      769 100.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   359   346   705 
Black (or African American)   12   11   23 
Hispanic/Latino   1   9   10 
Other   7   8   15 
Asian   7   7   14 
Japanese   0   1   1 
Native Hawaiian or Other Pacific Islander   0   1   1 
Presence of Cataract(s) [1] 
[Units: Participants]
     
Yes   59   63   122 
No   327   320   647 
[1] From baseline medical history
Presence of Diabetes [1] 
[Units: Participants]
     
Yes   70   61   131 
No   316   322   638 
[1] From baseline medical history
Received Androgen-deprivation Therapy (ADT) 
[Units: Participants]
     
Yes   350   353   703 
No   36   30   66 
Orchiectomy (Surgical Castration) 
[Units: Participants]
     
Yes   58   51   109 
No   328   332   660 
Screening Lens Opacities Classification System (LOCS) III Status [1] 
[Units: Participants]
     
< 3.0 at all sites [P, C, and NO]   299   299   598 
≥ 3.0 at any of these sites   87   84   171 
[1] 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.
Participant-reported History of Cataract [1] 
[Units: Participants]
     
Yes   35   35   70 
No   351   348   699 
[1] Participant-reported history of cataracts was a study stratification factor.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Lens Opacification Event Development or Progression by Month 12   [ Time Frame: 12 months ]

2.  Other Pre-specified:   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   [ Time Frame: 12 months ]

3.  Other Pre-specified:   Percentage of Participants With Lens Opacification Event Development or Progression by Month 6   [ Time Frame: 6 months ]

4.  Other Pre-specified:   Percentage of Participants With Confirmed Lens Opacification Event Development or Progression by Month 12   [ Time Frame: 12 months ]

5.  Other Pre-specified:   Percentage of Participants With a Decrease From Baseline in Best Corrected Visual Acuity (BCVA) of ≥ 10 Letters   [ Time Frame: Baseline and Months 3, 6, 9 and 12 ]

6.  Other Pre-specified:   Change From Baseline in Refraction Needed to Achieve BCVA   [ Time Frame: Baseline and months 3, 6, 9, and 12 ]

7.  Other Pre-specified:   Number of Participants With Adverse Events   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436



Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00925600     History of Changes
Other Study ID Numbers: 20080560
2009-012076-26 ( EudraCT Number )
First Submitted: June 18, 2009
First Posted: June 22, 2009
Results First Submitted: April 19, 2017
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017