A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: denosumab; placebo; open-label denosumab
Intervention description: double-blind phase: 60mg subcutaneous injection, single dose; double-blind phase: placebo subcutaneous injection, single dose; open-label phase: 60mg subcutaneous injection, single dose
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 135.0
Sex: Female
Minimum age: 60 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: denosumab; Republic of Korea; dual energy x-ray absorptiometry

Summary:

      The purpose of this study is to determine if denosumab is effective in increasing bone
      mineral density at the lumbar spine in Korean postmenopausal women with osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory Korean postmenopausal women with osteoporosis

          -  greater than 5 years postmenopausal

          -  aged 60 to 90 years old

          -  absolute bone mineral density value consistent with a T-score less than -2.5 and
             greater than or equal to - 4.0 at the either the lumbar spine or total hip, as
             measured by dual energy x-ray absorptiometry. Subjects with a T-score less than -4.0
             are at very high risk for fracture and will be excluded.

        Exclusion Criteria:

          -  previous or current metabolic bone disease, Paget's or Cushing's disease, or
             hyperprolactinemia

          -  current hypo- or hyperparathyroidism or hypo- or hyperthyroidism unless on stable
             thyroid replacement therapy and TSH level meets criteria

          -  rheumatoid arthritis

          -  cirrhosis of the liver or unstable liver disease or ALT or AST greater than or equal
             to 2.0 times the upper limit of normal, or alkaline phosphatase and bilirubin greater
             than or equal to 1.5 times the upper limit of normal

          -  medications used to treat osteoporosis, defined for type and duration of use, and
             including IV and oral bisphosphonates

          -  medications that affect bone metabolism including parathyroid hormone or derivatives;
             anabolic steroids or testosterone; glucocorticosteroids; systemic hormone replacement
             therapy; selective estrogen receptor modulators; tibolone, calcitonin, and calcitriol
             or vitamin D derivatives; other bone active drugs including anticonvulsives (but not
             benzodiazepines) and heparin; chronic systemic ketoconazole, androgens, ACTH,
             cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, and
             gonadotropin-releasing hormone agonists

          -  malignancy within 5 years except certain resected types

          -  malabsorption syndrome or gastrointestinal disorders associated with malabsorption

          -  abnormal calcium level

          -  vitamin D deficiency

          -  any laboratory abnormality that will prevent the subject from completing the study or
             interfere with interpretation of study results

          -  severe renal impairment or on dialysis

          -  impaired immune system or subject is taking immunosuppressants

          -  oral or dental conditions including current or past history of osteomyelitis or
             osteonecrosis of the jaw; active dental or jaw condition with requires oral surgery;
             planned invasive dental procedure; un-healed dental or oral surgery

          -  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 that will prevent the subject from completing the
             study or interferes with study results

          -  known to have tested positive for HIV

          -  less than two lumbar vertebrae evaluable for DXA measurements

          -  height, weight, or girth that may preclude accurate DXA measurements

          -  drug or alcohol abuse within 12 months that interferes with understanding or
             completing the study

          -  known sensitivity to mammalian cell-derived drug products

          -  use of an investigational drug or device within 30 days of enrollment or currently
             receiving other investigational agent(s)