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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00925600




Registration number
NCT00925600
Ethics application status
Date submitted
18/06/2009
Date registered
22/06/2009
Date last updated
30/05/2017

Titles & IDs
Public title
Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss
Scientific 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
Secondary ID [1] 0 0
2009-012076-26
Secondary ID [2] 0 0
20080560
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Cataract 0 0
Low Bone Mineral Density 0 0
Osteopenia 0 0
Osteoporosis 0 0
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Musculoskeletal 0 0 0 0
Osteoporosis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Denosumab
Other interventions - Placebo

Placebo Comparator: Placebo - Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.

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


Other interventions: Denosumab
Prefilled syringe for subcutaneous (SC) injection administered at a dose of 60 mg

Other interventions: Placebo
Prefilled syringe for subcutaneous (SC) injection
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Lens Opacification Event Development or Progression by Month 12
Timepoint [1] 0 0
12 months

Eligibility
Key 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
Minimum age
30 Years
Maximum age
120 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/05/2016
Sample size
Target
Accrual to date
Final
769
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Research Site - Wahroonga
Recruitment hospital [2] 0 0
Research Site - Herston
Recruitment hospital [3] 0 0
Research Site - Bentleigh East
Recruitment hospital [4] 0 0
Research Site - Ringwood East
Recruitment postcode(s) [1] 0 0
2076 - Wahroonga
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [4] 0 0
3135 - Ringwood East
Recruitment outside Australia
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United States of America
State/province [1] 0 0
California
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Colorado
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Connecticut
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Florida
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Idaho
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Indiana
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Kansas
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Louisiana
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Michigan
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Missouri
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Montana
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Nebraska
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New Jersey
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New York
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Tennessee
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Texas
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Virginia
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Bulgaria
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Pleven
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Plovdiv
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Nova Scotia
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Ontario
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Quebec
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Benesov
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Brno
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Kosice
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Martin
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Nitra
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Trencin
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Celje
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Tygerberg
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Kharkiv
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Kyiv
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Uzhgorod
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Ukraine
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Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00925600
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00925600