A Randomized, Double-Blind, Placebo-controlled Study to Evaluate AMG 162 in theTreatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy forNon-metastatic Prostate Cancer
- Conditions
- Bone loss in patients undergoing androgen-deprivation therapy (ADT) for non-metastatic prostate cancer.
- Registration Number
- EUCTR2004-000512-17-HU
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 968
- Patients = 70 years of age, with histologically confirmed prostate cancer
- Adult patients, < 70 years of age, with histologically confirmed prostate cancer and a history of osteoporotic fracture, or BMD t-score at the lumbar spine, total hip, or femoral neck < -1.0 (BMD using the male normative database)
- Have undergone bilateral orchiectomy or initiated ADT with GnRH agonists and
is expected to continue on with ADT for at least 12 months
- ECOG score 0, 1, or 2
- Before any study-specific procedure, provide written 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
- Evidence of distant metastases
- Concurrent systemic anti-neoplastic therapy, other than ADT and/or antiandrogen
therapy
- PSA > 5 ng/mL after being on ADT >1 month
- BMD t-score < -4.0 at lumbar spine, total hip, or femoral neck
- Height, weight, and girth which may preclude accurate DXA measurements
- Less than 2 evaluable lumbar vertebrae (L1-L4) for DXA measurement
- Current administration of oral bisphosphonates, or previous use as follows:
• Greater than or equal to 3 years continuously
• Greater than 3 months but less than 3 years (eligible only if patient has a 1 year washout prior to randomization)
- Current administration of IV bisphosphonates, fluoride, strontium ranelate, or gallium nitrate, within the past 5 years
- Administration of any of the following treatments within the past 6 weeks:
• PTH or PTH derivatives
• Anabolic steroids or testosterone
• Glucocorticoids (> 10 mg prednisone/day for more than 10 days)
• Selective estrogen receptor modulators (SERMS)
• Calcitonin
• Calcitriol
- Prior administration of OPG construct (i.e. AMGN-0007, Fc-OPG), or AMG 162
- Concurrent use of PC SPES
- 25-hydroxyvitamin D deficiency (< 12 ng/mL)
- Albumin-adjusted serum calcium < 2.0 mmol/L (8.0 mg/dL), or . 2.9 mmol/L (11.5 mg/dL)
- Serum creatinine > 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]
- 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
- Currently enrolled in or has not yet completed at least 4 weeks washout since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
- 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.
- iPTH> 1.5 x ULN
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the treatment effect of AMG 162 compared with placebo on lumbar<br>spine bone mineral density (BMD) in men with nonmetastatic prostate cancer undergoing ADT.;Secondary Objective: - To assess the effect of AMG 162 compared with placebo on the following:<br>o Vertebral and non-vertebral fracture incidence<br>o BMD in total hip and femoral neck<br>- To assess the safety and pharmacokinetics of AMG 162 in this population;Primary end point(s): The primary endpoint is the percentage change from baseline in lumbar spine BMD.
- Secondary Outcome Measures
Name Time Method