Postmenopausal osteoporosis /osteopenia
Conditions
Interventions
Product Name: Denosumab
Product Code: AMG 162
Pharmaceutical Form: Solution for injection
CAS Number: 615258-40-7
Current Sponsor code:
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Ambulatory postmenopausal women based on medical history. -BMD values (g/cm2), assessed at the local site that correspond to T-score = -2.0 at the lumbar spine OR total hip as follows: a) For the lumbar spine, the BMD values (g/cm2) must be =0.940 (GE lunar) or =0.827 (Hologic) b) For the total hip, the BMD values (g/cm2) must be =0.756 (GE lunar) or =0.698 (Hologic) -Provide the appropriate written informed consent before any study-specific procedure. 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
Exclusion criteria: -Any disorder that compromises the ability of the subject to give written informed consent and /or to comply with study procedures -Evidence of any of the following: a) Hyper- or hypothyroidism b) Current hyper- or hypoparathyroidism c) Elevated transaminases d) Significantly impaired renal function as determined by serum creatinine = 2.0 mg/dL e) Current hypo- or hypercalcemia based on the central laboratory reference ranges f) Active gastric or duodenal ulcer; history of significant gastrointestinal bleed requiring hospitalization or transfusion, or dyspepsia or gastroesophageal reflux disease that is uncontrolled by medication g) Rheumatoid Arthritis, Paget’s disease, Cushing’s disease, hyperprolactinemia, or cirrhosis of the liver h) Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen i) Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years j) Any metabolic bone disease, eg, osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings k) Malabsorption syndrome or any gastrointestinal disorders that are associated with malabsorption -Received any solid organ or bone marrow transplant. -Vitamin D deficiency (25(OH) vitamin D level < 12 ng/mL). -Any 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. -Contraindicated or poorly tolerant of ALN therapy. -Known sensitivity to mammalian cell derived drug products. -Known intolerance to calcium supplements. -Administration of intravenous bisphosphonate, or fluoride (except for dental treatment) or strontium ranelate. -Oral bisphosphonate treatment: • = 3 months cumulatively in the past 2 years, OR • = 1 month in the past year, OR • Any use during the 3-month period prior to randomization -PTH or PTH derivatives (eg, teriparatide) within the last year. -Administration of any of the following treatments within 3 months of randomization: a) Any SERM (eg, raloxifene) b) Tibolone c) Anabolic steroids or testosterone d) Glucocorticosteroids (= 5 mg prednisone equivalent per day for more than 10 days) e) Systemic (oral, transdermal, topical) hormone replacement therapy (local vaginal estrogen preparation will be allowed) f) Calcitonin g) Calcitriol or vitamin D derivatives h) Other bone active drugs including anti-convulsives (except benzodiazepines) and heparin i) Chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists -Height, weight or girth which may preclude accurate DXA measurements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of denosumab compared to treatment with alendronate sodium (ALN) on percent change from baseline in bone mineral density (BMD) at the total hip as measured by dual energy X-ray absorptiometry (DXA) at 12 months in postmenopausal women.; Secondary Objective: To evaluate the effects of denosumab compared to treatment with ALN on: • Percent change from baseline in BMD at the distal 1/3 radius, hip trochanter, femoral neck, and lumbar spine as measured by DXA at 12 months. • Safety and tolerability as measured by evaluating adverse events, laboratory parameters, and vital signs over 12 months. ;Primary end point(s): The primary efficacy endpoint is the percent change from baseline in total hip BMD at 12 months. | — |
Countries
Belgium, Denmark, Germany, Spain, United Kingdom
Outcome results
None listed