Treatment of postmenopausal osteoporosis
Conditions
Interventions
Product Name: AMG 162 solution for injection
Pharmaceutical Form: Solution for injection
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
Rou
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Postmenopausal women, between 60 and 90 years old - BMD T-score =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - BMD T-score 3 months, but = 3 years, at least a one year period since last dose is necessary for eligibility; If used = 3 months at any time in the past, subject is eligible. - Administration of intravenous bisphosphonate, fluoride or strontium for osteoporosis within the last 5 years - Administration of any of the following treatments within the last 6 weeks: a) PTH or PTH derivatives, eg, teriparatide b) Anabolic steroids or testosterone c) Glucocorticosteroids (> 5 mg prednisone equivalent per day for more than 10 days) d) Systemic hormone replacement therapy e) Selective estrogen receptor modulators (SERMs), eg, raloxifene f) Tibolone g) Calcitonin h) Calcitriol - Evidence of any of the following per patient report, chart review, DXA, or X-ray review: a) Hyper or hypothyroidism; patients on stable thyroid treatment with a normal TSH will be allowed b) Current hyper- or hypoparathyroidism c) Current hypocalcemia (albumin adjusted serum calcium below 2.13 mmol/L [8.5 mg/dL]) d) Vitamin D deficiency [(25) hydroxy Vitamin D level < 12 ng/mL) e) Rheumatoid arthritis f) Paget’s disease g) Malignancy (except basal cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years h) Any bone disease, eg, osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings i) Malabsorption syndrome j) Height, weight and girth which may preclude accurate DXA measurements k) Advanced scoliosis or extensive lumbar fusion which would preclude vertebral fracture assessment l) Any severe or more than 2 moderate vertebral fractures on spinal X-rays (see section 7.9) m) Less than 2 lumbar vertebrae (L1-L4) evaluable for DXA - Known sensitivity to mammalian cell derived drug products - Any organic or psychiatric disorder, or laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results - Evidence of alcohol or substance-abuse within the last 12 months that the investigator believes would interfere with understanding or completing the study - Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures - For biopsy sub study subjects only: known or suspected sensitivity or contraindication to tetracycline derivatives - Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine whether denosumab (formerly known as AMG 162 treatment can reduce the number of postmenopausal osteoporotic women (BMD T-score below -2.5) with inew vertebral fractures as compared with control (placebo plus vitamin D and calcium). The primary safety objective is to characterize the safety and tolerability profile of denosumab in this population based on the adverse event incidence, changes in laboratory profiles, and immunogenicity to denosumab.;Secondary Objective: Secondary objectives will be to assess the effect of denosumab on time to first non-vertebral fracture and time to first hip fracture. ;Primary end point(s): Efficacy - Subject incidences of new vertebral fractures (Yes/No) during the entire 36 month treatment period. Safety - Adverse event incidence by system organ class and preferred term - Changes in safety laboratory analytes (serum chemistry, hematology) at each visit - Numebr of subjects with anti-AMG 162 antibodies (Yes/No) | — |
Countries
Czech Republic, Denmark, Finland, Hungary, Italy, Latvia, Lithuania, Norway, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed