Please note that the ANZCTR website will be unavailable from 1pm until 2pm (AEST) on Wednesday 29th May for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00925600
Ethics application status
Date submitted
18/06/2009
Date registered
18/06/2009
Date last updated
19/04/2017

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
Eye 0 0 0 0
Diseases / disorders of the eye
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

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 - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Montana
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Pleven
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Plovdiv
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Sofia
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Nova Scotia
Country [30] 0 0
Canada
State/province [30] 0 0
Ontario
Country [31] 0 0
Canada
State/province [31] 0 0
Quebec
Country [32] 0 0
Czechia
State/province [32] 0 0
Benesov
Country [33] 0 0
Czechia
State/province [33] 0 0
Brno
Country [34] 0 0
Czechia
State/province [34] 0 0
Hradec Kralove
Country [35] 0 0
Czechia
State/province [35] 0 0
Jindrichuv Hradec
Country [36] 0 0
Czechia
State/province [36] 0 0
Kromeriz
Country [37] 0 0
Czechia
State/province [37] 0 0
Novy Jicin
Country [38] 0 0
Czechia
State/province [38] 0 0
Olomouc
Country [39] 0 0
Czechia
State/province [39] 0 0
Plzen
Country [40] 0 0
Czechia
State/province [40] 0 0
Praha 2
Country [41] 0 0
Czechia
State/province [41] 0 0
Praha 4
Country [42] 0 0
Czechia
State/province [42] 0 0
Praha 6
Country [43] 0 0
Czechia
State/province [43] 0 0
Usti nad Labem
Country [44] 0 0
Czechia
State/province [44] 0 0
Zlin
Country [45] 0 0
France
State/province [45] 0 0
Lyon Cédex 3
Country [46] 0 0
France
State/province [46] 0 0
Paris Cedex 5
Country [47] 0 0
Greece
State/province [47] 0 0
Alexandroupoli
Country [48] 0 0
Greece
State/province [48] 0 0
Athens
Country [49] 0 0
Greece
State/province [49] 0 0
Heraklion
Country [50] 0 0
Greece
State/province [50] 0 0
Larissa
Country [51] 0 0
Greece
State/province [51] 0 0
Patra
Country [52] 0 0
Greece
State/province [52] 0 0
Thessaloniki
Country [53] 0 0
Hungary
State/province [53] 0 0
Baja
Country [54] 0 0
Hungary
State/province [54] 0 0
Budapest
Country [55] 0 0
Hungary
State/province [55] 0 0
Gyor
Country [56] 0 0
Hungary
State/province [56] 0 0
Miskolc
Country [57] 0 0
Hungary
State/province [57] 0 0
Nyiregyhaza
Country [58] 0 0
Hungary
State/province [58] 0 0
Szeged
Country [59] 0 0
India
State/province [59] 0 0
Gujarat
Country [60] 0 0
India
State/province [60] 0 0
Karnataka
Country [61] 0 0
India
State/province [61] 0 0
Maharashtra
Country [62] 0 0
India
State/province [62] 0 0
Punjab
Country [63] 0 0
India
State/province [63] 0 0
Tamil Nadu
Country [64] 0 0
India
State/province [64] 0 0
West Bengal
Country [65] 0 0
Latvia
State/province [65] 0 0
Jelgava
Country [66] 0 0
Latvia
State/province [66] 0 0
Riga
Country [67] 0 0
Mexico
State/province [67] 0 0
Distrito Federal
Country [68] 0 0
New Zealand
State/province [68] 0 0
Christchurch
Country [69] 0 0
New Zealand
State/province [69] 0 0
Takapuna, North Shore City
Country [70] 0 0
New Zealand
State/province [70] 0 0
Tauranga
Country [71] 0 0
New Zealand
State/province [71] 0 0
Whangarei
Country [72] 0 0
Poland
State/province [72] 0 0
Gdansk
Country [73] 0 0
Poland
State/province [73] 0 0
Gdynia
Country [74] 0 0
Poland
State/province [74] 0 0
Katowice
Country [75] 0 0
Poland
State/province [75] 0 0
Myslowice
Country [76] 0 0
Poland
State/province [76] 0 0
Opole
Country [77] 0 0
Poland
State/province [77] 0 0
Poznan
Country [78] 0 0
Poland
State/province [78] 0 0
Rzeszow
Country [79] 0 0
Poland
State/province [79] 0 0
Siedlce
Country [80] 0 0
Poland
State/province [80] 0 0
Slupsk
Country [81] 0 0
Poland
State/province [81] 0 0
Szczecin
Country [82] 0 0
Poland
State/province [82] 0 0
Warszawa
Country [83] 0 0
Poland
State/province [83] 0 0
Wroclaw
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Ivanovo
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Moscow
Country [86] 0 0
Russian Federation
State/province [86] 0 0
Nizhny Novgorod
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Rostov-na-Donu
Country [88] 0 0
Slovakia
State/province [88] 0 0
Bratislava
Country [89] 0 0
Slovakia
State/province [89] 0 0
Kosice
Country [90] 0 0
Slovakia
State/province [90] 0 0
Martin
Country [91] 0 0
Slovakia
State/province [91] 0 0
Nitra
Country [92] 0 0
Slovakia
State/province [92] 0 0
Trencin
Country [93] 0 0
Slovenia
State/province [93] 0 0
Celje
Country [94] 0 0
Slovenia
State/province [94] 0 0
Ljubljana
Country [95] 0 0
Slovenia
State/province [95] 0 0
Slovenj Gradec
Country [96] 0 0
South Africa
State/province [96] 0 0
Western Cape
Country [97] 0 0
South Africa
State/province [97] 0 0
George
Country [98] 0 0
South Africa
State/province [98] 0 0
Kempton Park
Country [99] 0 0
South Africa
State/province [99] 0 0
Port Elizabeth
Country [100] 0 0
South Africa
State/province [100] 0 0
Tygerberg
Country [101] 0 0
Ukraine
State/province [101] 0 0
Chernivtsi
Country [102] 0 0
Ukraine
State/province [102] 0 0
Dnipropetrovsk
Country [103] 0 0
Ukraine
State/province [103] 0 0
Kharkiv
Country [104] 0 0
Ukraine
State/province [104] 0 0
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
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/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
Other publications