Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
55–75
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Ambulatory Indian postmenopausal women with osteoporosis
greater than 5 years postmenopausal
aged 55 to 75 years old
absolute bone mineral density value consistent with a T-score less than -2.5 and greater than - 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 or equal to -4.0 are at very high risk for fracture and will be excluded.
You may not be if
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 interferes with interpretation of study results
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)
