Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
55–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Ambulatory postmenopausal women.
Age 55 years or older
Subject has provided informed consent prior to any study specific procedures
Received oral bisphosphonate therapy for osteoporosis at least 2 years prior to screening visit
Screening BMD (g/cm²) values at the lumbar spine, total hip or femoral neck values of equal to or less than those listed in the protocol.
At least 2 lumbar vertebrae and one hip must be evaluable by dual energy x-ray absorptiometry (DXA) at the screening visit
You may not be if
Received other osteoporosis treatment or bone active treatment
Evidence of history of any of the following:
* hyperthyroidism (stable on antithyroid therapy is allowed)
* hypothyroidism (stable on thyroid replacement therapy is allowed)
* hypo- or hyperparathyroidism
* hypo- or hypercalcemia based on the central laboratory reference ranges
* Recent tooth extraction (within 6 months of screening visit)
* Paget disease of bone (subject report or chart review)
* other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta) (chart review)
Abnormalities of the following per central laboratory reference ranges:
* vitamin D deficiency (25\[OH\] vitamin D level \< 20 ng/mL), repletion will be allowed and subjects may be re-screened
* hypercalcemia
* elevated transaminases ≥ 2.0 x upper limits of normal (ULN)
History of any solid organ or bone marrow transplant
Malignancy (except nonmelanoma skin cancers, cervical or breast ductal carcinoma in situ) within the last 5 years
Known intolerance to calcium or vitamin D supplements
Self-reported alcohol or drug abuse within 12 months prior to screening
Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s)
History or evidence of any other clinically significant disorder, condition or disease that in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
