A Randomized, Double-Blind, Placebo-controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000512-17-FI

Enrollment

1468

Registered

2004-07-16

Start date

2004-10-01

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone loss in pateints undergoing androgen-deprivation therapy (ADT) for non-metastatic prostate cancer. MedDRA version: 8.1 Level: LLT Classification code 10049470 Term: Bone density decreased

Interventions

Product Name: Denosumab Product Code: AMG 162 Pharmaceutical Form: Solution for injection CAS Number: 615258 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 Rout

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Patients = 70 years of age, with histologically confirmed prostate cancer or - Adult patients, =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Evidence of distant metastases - Concurrent systemic anti-neoplastic therapy, other than ADT and/or antiandrogen therapy - Diagnosis of any secondary non- prostate malignancy within 5 years of randomization, except for adequately treated basal cell or squamous cell skin - PSA > 5 ng/mL after being on ADT >1 month - BMD t-score 10 mg prednisone/day for more than 10 days) • Selective estrogen receptor modulators (SERMS) • Calcitonin • Calcitriol - Concurrent chronic corticosteroid therapy or pulse corticosteroid therapy (topical, inhaled, or nasal steroids are allowed) - Prior administration of OPG construct (i.e. AMGN-0007, Fc-OPG), or AMG 162 - Concurrent use of PC SPES - 25-hydroxyvitamin D deficiency ( 177 µmol/L (>2.0 mg/dL) - Hepatic insufficiency [AST > 2.5 x upper limit of normal (ULN), ALT > 2.5 x ULN, or total bilirubin > 1.5 x ULN] - iPTH > 1.5 x ULN - ANC < 1.5 x 109/L; platelets < 100 x 109/L; or hemoglobin < 6.2 mmol/L (10.0 g/dL) - Evidence of any of the following conditions per subject self report or chart review: a) Current hyper- or hypothyroidism (stable on thyroid replacement therapy is allowed, if the TSH is within the normal range) b) Paget’s disease, Cushing’s disease, hyperprolactinemia, or chronic liver disease c) Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization d) Major surgery, or significant traumatic injury occurring within 4 weeks before randomization e) Known HIV, HCV, or chronic Hepatitis B infection - 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 - Any kind of disorder that compromises his ability to give written informed consent and/or to comply with study procedures - 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 - Self-reported drug or alcohol abuse within the previous 24 weeks before study enrollment - Known sensitivity to any of the products to be administered during this study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the treatment effect of AMG 162 compared with placebo on lumbar spine bone mineral density (BMD) at month 24 in men with nonmetastatic prostate cancer undergoing ADT.;Primary end point(s): The primary endpoint is the percentage change from baseline in lumbar spine BMD to month 24.;Secondary Objective: - To assess the effect of AMG 162 compared with placebo on the following: – Percent change of femoral neck BMD, and total hip BMD from baseline to month 24 – Percent change of lumbar spine BMD, femoral neck BMD and total hip BMD from baseline to month 36 – Subject incidence of any fracture and subject incidence of new vertebral fracture over the 36-month evaluation period – Time to first clinical fracture over the 36-month evaluation period – Subject incidence of any fracture over the 24- month evaluation period - To assess the safety and pharmacokinetics of AMG 162 in this population. Safety will be followed for up to 2 years after the end of the 36-month treatment phase (as described in Section 7.18).	—

Measure

Time frame

Main Objective: To determine the treatment effect of AMG 162 compared with placebo on lumbar spine bone mineral density (BMD) at month 24 in men with nonmetastatic prostate cancer undergoing ADT.;Primary end point(s): The primary endpoint is the percentage change from baseline in lumbar spine BMD to month 24.;Secondary Objective: - To assess the effect of AMG 162 compared with placebo on the following: – Percent change of femoral neck BMD, and total hip BMD from baseline to month 24 – Percent change of lumbar spine BMD, femoral neck BMD and total hip BMD from baseline to month 36 – Subject incidence of any fracture and subject incidence of new vertebral fracture over the 36-month evaluation period – Time to first clinical fracture over the 36-month evaluation period – Subject incidence of any fracture over the 24- month evaluation period - To assess the safety and pharmacokinetics of AMG 162 in this population. Safety will be followed for up to 2 years after the end of the 36-month treatment phase (as described in Section 7.18).

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Countries

Czech Republic, Finland, Hungary

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026