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This study is to evaluate the efficacy and safety of denosumab 60 milligrams (mg) for 12 month treatment in Chinese postmenopausal women with osteoporosis at increased risk of fracture.
Full description
The aim of this Phase III, randomized, double-blind, placebo-controlled, parallel-group study is to evaluate the efficacy and safety of denosumab (DMAb) in Chinese postmenopausal women with osteoporosis at increased risk of fracture. The study design consists of two phases: Screening and 12-month Double-Blind treatment phase. Following the Screening phase, all eligible subjects will be randomized to receive Double-Blind DMAb (60 mg) or Placebo study medication in a 3:1 ratio. DMAb 60 mg and placebo will be administered as a single subcutaneous (SC) injection at the beginning of the Double-Blind phase and at 6 months following the initial dose. All subjects will receive daily supplementation of oral elemental calcium (at least 600 mg) and vitamin D (at least 400 International Units [IU]). The primary objective is to determine the effects of DMAb compared to placebo with respect to mean percent change in BMD at the lumbar spine, as measured by dual-energy x-ray absorptiometry (DXA), from Baseline to Month 12. Secondary objectives include the evaluation between the DMAb and placebo treatment groups: change in BMD: at the lumbar spine (Month 6), total hip (Months 6 and 12), femoral neck (Months 6 and 12) and trochanter (Months 6 and 12); and serum biomarkers of bone formation and resorption (Months 6 and 12). Clinical safety of denosumab will also be assessed in this population.
Enrollment
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Inclusion criteria
history of fracture parental history of hip fracture increased bone turnover rate at screening (s-CTX >1.0 SD above the mean in healthy premenopausal women) low body weight (BMI≤19kg/m2) elderly (age≥70y) current smoker
Exclusion criteria
Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings.
Paget's disease Cushing's disease Hyperprolactinemia
If TSH level is below normal range, subject is not eligible for the study. If TSH level is elevated (>5.5 μIU/mL and ≤10.0 μIU/mL), serum T4 should be measured.
If serum T4 is within normal range, subject is eligible. If serum T4 is outside of normal range, subject is not eligible for the study. If TSH level is > 10.0 μIU/mL, subject is not eligible.
Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5years.
Cirrhosis of the liver Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). Chronic stable hepatitis B and C are acceptable if the subject otherwise meets study entry criteria (e.g., presence of hepatitis B surface antigen or positive Hepatitis C test result within 3 months of Screening).
Any disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures.
Any physical or psychiatric disorder which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results.
Known to have tested positive for human immunodeficiency virus (HIV).
Concomitant Medications:
If used for ≥3 years cumulatively, subject is ineligible.
If used for >3-months but <3 years cumulatively:
If the last dose was <1 year before enrolment, subject is ineligible. If the last dose was ≥1 year before enrolment, subject is eligible. If used ≤3 months, cumulatively, subject is eligible.
Parathyroid hormone (PTH) or PTH derivatives, e.g., teriparatide. Anabolic steroids or testosterone. Glucocorticosteroids (>5 mg prednisone equivalent per day for more than 10 days).
Systemic hormone replacement therapy. Selective estrogen receptor modulators (SERMs), e.g., raloxifene Tibolone. Calcitonin. Calcitriol or vitamin D derivatives. Other bone active drugs including anti-convulsives (except benzodiazepines) and heparin.
Chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists.
Serum aspartate aminotransferase (AST) ≥2.0 x upper limits of normal (ULN). Serum alanine aminotransferase (ALT) ≥2.0 x ULN. Alkaline phosphatase and bilirubin ≥1.5 x ULN (isolated bilirubin ≥1.5 ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%.
Less than two lumbar vertebrae evaluable for DXA measurements. Height, weight, or girth which may preclude accurate DXA measurements.
Primary purpose
Allocation
Interventional model
Masking
486 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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