Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Placebo; Denosumab
Intervention description: Administered by subcutaneous injection; Administered by subcutaneous injection
Intervention MeSH terms: Denosumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Healthy volunteers: No
Keywords: Postmenopausal; Denosumab

Summary:

      The primary objective was to evaluate the safety and tolerability of denosumab (AMG 162)
      after a single subcutaneous administration in Japanese postmenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ambulatory women between the ages of 40 and 64 years, inclusive

          -  postmenopausal, defined as amenorrheic for at least 24 months

          -  clinically acceptable physical exam

          -  clinical laboratory tests (complete blood count [CBC], blood chemistries, urinalysis)
             within normal limits or clinically acceptable to the investigator/sponsor at the time
             of screening with the exception of aspartate transaminase (AST) and alkaline
             phosphatase (ALT), which must be < 1.25 times the upper limit of normal, or
             gamma-glutamyl transpeptidase (GGT), which must be < 1.5 times the upper limit of
             normal

          -  normal or clinically acceptable electrocardiogram (ECG) (12-lead reporting ventricular
             rate and PR, QRS, QT, and QTc intervals)

          -  body mass index between 17 and 27

          -  willing to sign an approved informed consent form before any study-specific
             assessments and oral consultations are performed

        Exclusion Criteria:

          -  administration of medications within 6 months before investigational product
             administration that are known to effect bone metabolism, including but not limited to
             the following: calcitonin, parathyroid hormone (or any derivative), supplemental
             vitamin D (> 1000 IU/day), glucocorticosteroids (inhaled or topical corticosteroids
             administered more than 2 weeks before the date of informed consent were allowed),
             anabolic steroids, calcitriol and available analogues, diuretics

          -  administration of the following medications within 12 months before study drug
             administration: bisphosphonates, fluoride for osteoporosis

          -  diagnosed with any condition that affects bone metabolism

          -  greatly differing levels of physical activity compared with the 6 months before
             investigational product administration or constant levels of intense physical
             activities

          -  routine alcohol intake of ≥ 2 drinks/day, on average, within 6 months of
             investigational product administration

          -  known sensitivity to any drugs

          -  positive test results for hepatitis B surface antigen, hepatitis C virus, human
             immunodeficiency virus antigen/antibody, syphilis

          -  receiving or received any investigational drug (or was currently using an
             investigational device) within 4 months before receiving investigational product

          -  donated any amount of blood within 16 weeks, or over 400 mL (Note: not 400 mL but 200
             mL, for the subjects who were to be enrolled into cohorts 4 or 5) within 1 year of the
             start day of screening

          -  subject had previously entered this study

          -  any other condition that might have reduced the chance of obtaining data (eg, known
             poor compliance) required by the protocol or that might have compromised the ability
             to give truly informed consent