Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
45–80
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Postmenopausal women (postmenopausal is defined as no vaginal bleeding or spotting for at least 12 months)
Low bone mineral density (BMD) as determined by screening BMD T-scores of the lumbar spine (L1 to L4), or total evaluable vertebrae (if fewer than L1 to L4), or total hip ≤ -1.0
Receiving a 50 mg dose of etanercept once weekly ≥ 6 months prior to screening and expected to continue etanercept treatment at this dose and frequency through end of study (EOS)
If currently taking methotrexate (MTX), receiving a stable dose (7.5 to 20 mg/week) of MTX ≥ 8 weeks prior to screening
Willing and able to take ≥ 1,000 mg elemental calcium and ≥ 400 IU vitamin D daily upon enrollment
You may not be if
Type 1 diabetes; OR poorly controlled Type 2 diabetes (hemoglobin A1c (HbA1c) \> 8.0% at screening; HbA1c ≤ 8.0% within 6 months of screening is acceptable if supporting laboratory documentation is available)
History of heart failure, coronary artery bypass graft, or cardiac arrhythmia; OR history of acute coronary syndrome
Comorbid autoimmune disease, demyelinating disease, or hematologic abnormalities
History of joint replacement in hand and/or wrist; OR history of fused joint in hand and/or wrist
Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw; OR active dental or jaw condition that requires oral surgery, or non-healed dental/oral surgery; OR planned invasive dental procedure(s) during the course of the study
