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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Treatment: Other - Denosumab
Treatment: Other - 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.


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

Treatment: Other: Placebo
Prefilled syringe for subcutaneous (SC) injection
Intervention code [1] 0 0
Treatment: Other
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
Other
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
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
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United States of America
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Louisiana
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United States of America
State/province [10] 0 0
Maryland
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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Montana
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United States of America
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Nebraska
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United States of America
State/province [16] 0 0
New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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Bulgaria
State/province [25] 0 0
Pleven
Country [26] 0 0
Bulgaria
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Plovdiv
Country [27] 0 0
Bulgaria
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Sofia
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Benesov
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Jindrichuv Hradec
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Czechia
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Kromeriz
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Czechia
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Novy Jicin
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Czechia
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Olomouc
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Czechia
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Plzen
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Czechia
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Praha 2
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Czechia
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Praha 4
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Czechia
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Praha 6
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Czechia
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Usti nad Labem
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Czechia
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Zlin
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France
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Lyon Cédex 3
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France
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Paris Cedex 5
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Greece
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Alexandroupoli
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Greece
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Athens
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Greece
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Heraklion
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Greece
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Larissa
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Greece
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Patra
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Greece
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Thessaloniki
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Hungary
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Baja
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Hungary
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Budapest
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Hungary
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Gyor
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Hungary
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Miskolc
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Hungary
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Nyiregyhaza
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Hungary
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Szeged
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India
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Gujarat
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Karnataka
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Tamil Nadu
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Riga
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Distrito Federal
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New Zealand
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Christchurch
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New Zealand
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Takapuna, North Shore City
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New Zealand
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Tauranga
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New Zealand
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Whangarei
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Poland
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Gdansk
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Gdynia
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Katowice
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Myslowice
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Opole
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Poznan
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Rzeszow
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Siedlce
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Slupsk
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Szczecin
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Warszawa
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Poland
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Wroclaw
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Russian Federation
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Ivanovo
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Russian Federation
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Moscow
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Rostov-na-Donu
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Slovakia
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Martin
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Slovakia
State/province [91] 0 0
Nitra
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Slovakia
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Trencin
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Slovenia
State/province [93] 0 0
Celje
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Slovenia
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Ljubljana
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Slovenia
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Slovenj Gradec
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South Africa
State/province [96] 0 0
Western Cape
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South Africa
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George
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South Africa
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Kempton Park
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South Africa
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Port Elizabeth
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South Africa
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Tygerberg
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Ukraine
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Chernivtsi
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
Country [105] 0 0
Ukraine
State/province [105] 0 0
Uzhgorod
Country [106] 0 0
Ukraine
State/province [106] 0 0
Zaporizhzhya

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00925600