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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 22 May 2017
Main ID:  EUCTR2009-012076-26-FR
Date of registration: 06/08/2009
Prospective Registration: Yes
Primary sponsor: Amgen Inc
Public 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
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
Date of first enrolment: 01/10/2009
Target sample size: 760
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012076-26
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Bulgaria Czech Republic France Greece Hungary Latvia Poland Slovakia
Slovenia
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
Men = 30 of age with non-metastatic prostate cancer

Have undergone bilateral orchiectomy or initiated ADT with GnRH agonists and is expected to continue on ADT for at least 12 months

ECOG score (0, 1, or 2)

Baseline BCVA of 20/40, (6/12 or 0.5 on the decimal scale) or better using the ETDRS charts at 4 meters in one eye with a natural, intact lens

Bone Mineral Density (BMD) requirements:
• If < 70 years: BMD T-score at the lumbar spine, total hip, or femoral neck = -2.5 and = -1.0 (“osteopenia”; at least one site required).
• If = 70 years: BMD T-score at lumbar spine and total hip and femoral neck = -2.5
• At least 2 evaluable lumbar vertebrae

Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Screening LOCS III grade of = 3.5 for P, = 4.0 for C, or = 4.5 for NO

Bone Mineral Density (BMD) T-score < -2.5 at lumbar spine and/or total hip and/or femoral neck (“osteoporosis”)

Known history of prior fragility fracture (fractures associated with no or minimal trauma severity [eg, fall from standing height])

Evidence of distant metastases

Diagnosis of any secondary non-prostate malignancy within 5 years of randomization, except for adequately treated basal cell or squamous cell skin cancer

Known HIV, HCV, or Hepatitis B Infection

Known osteonecrosis of the jaw (ONJ)

Current hyper-or hypothyroidism (stable on thyroid replacement therapy is allowed, if the TSH is within the normal range)

Paget’s disease, Cushing’s disease, hyperprolactinemia, chronic liver disease or rheumatoid arthritis

Dialysis or expected to undergo dialysis within 1 year

Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization

Major surgery, or significant traumatic injury occurring within 4 weeks before randomization

Incisional eye surgery in both eyes or cataract surgery in both eyes

Ocular disease leading to visual loss (eg, macular degeneration, glaucoma, corneal disease) that would make assessment of visual status difficult.

Planned cataract surgery or major visual disturbance expected to result in need for cataract surgery within one year

Concurrent systemic anti-neoplastic therapy or radiotherapy, other than ADT and/or anti-androgen therapy

Current administration of IV bisphosphonates (oral bisphosphonates allowable if they are stopped at study entry)

Concurrent use of anti-glaucoma medications

Concurrent chronic corticosteroid therapy or pulse corticosteroid therapy including ophthalmologic steroid use (topical, inhaled, or nasal steroids are allowed)

Incapable of being responsive to midriatic agents (minimum of approximately a 6 mm pupil required)

Prior administration of denosumab

PSA > 5 ng/mL at screening

Serum calcium or albumin-adjusted serum calcium levels < 2.0 mmol/L (8.0 mg/dL), or = 2.9 mmol/L (11.5 mg/dL)

25-hydroxyvitamin D deficiency (< 20 ng/mL)

Not willing to use 2 highly effective methods of contraception during treatment and for 10 months after the end of treatment

Subject with a pregnant partner who is not willing to use a condom during treatment and for additional 10 months after the end of treatment

Is currently enrolled in the active treatment phase of a study investigating an unapproved product or device, or has been treated within the last 30 days with an unapproved product or device. Subjects in the observational phase of clinical studies (eg, to collect survival data) are allowed

Organic or psychiatric disorder which, in the opinion of the investigator may prevent the subject from completing the study or interfere with the interpretation of the study results


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes
Health Condition(s) or Problem(s) studied
Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy (ADT) for Non-metastatic Prostate Cancer
MedDRA version: 12.0 Level: LLT Classification code 10065687 Term: Bone loss
Intervention(s)

Product Name: Denosumab
Product Code: AMG 162
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Denosumab
CAS Number: 615258-40-7
Current Sponsor code: AMG 162
Other descriptive name: Abx 1-6 CHO OPG Ligand mAb IgG2;Human Monoclonal Antibody to RANKL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)
Main Objective: To assess the effect of denosumab on cataract event development or progression by month 12 based on a change of = 1.0 in posterior subcapsular (P), = 1.0 in cortical (C), or = 0.7 in nuclear opalescence (NO) using the Lens Opacities Classification System III (LOCS III) score.
Primary end point(s): Subject incidence of cataract event development or progression by month 12, based on a change of = 1.0 in P, = 1.0 in C, or = 0.7 in NO in the LOCS III score.
Secondary Objective: To assess the effect of denosumab on cataract 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 using the LOCS III score
To assess the effect of denosumab on cataract event development or progression by month 6 based on LOCS III scores
To assess the effect of denosumab on confirmed cataract event development or progression by month 12 based on LOCS III scores
To assess the effect of denosumab on the incidence of decreased best corrected visual acuity (BCVA) from the baseline BCVA on the ETDRS (“Early Treatment Diabetic Retinopathy Study”) charts
To assess the effect of denosumab on change in refraction needed to achieve BCVA
To describe the safety of denosumab administration as measured by adverse events and safety laboratory parameters
Secondary Outcome(s)
Secondary ID(s)
20080560
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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