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 based on medical history
\> or = 55 years of age at the start of screening
Screening bone mineral density (BMD) values (g/cm²), at the lumbar spine OR femoral neck OR total hip that occur within the specified ranges based on the particular scanner that is used. At least 2 lumbar vertebrae must be evaluable by Dual X-ray Absorptiometry (DXA), or at least one hip must be evaluable by DXA
Provide written informed consent before any study specific procedure is performed.
You may not be if
Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Hyper- or hypothyroidism; however, stable subjects, in the investigator's opinion, on thyroid hormone replacement therapy are allowed
Current hyper- or hypoparathyroidism
Current hypo- or hyper calcemia based on the central laboratory reference ranges for albumin-adjusted serum calcium
Rheumatoid arthritis, Paget's disease, Cushing's disease, hyperprolactinemia, or cirrhosis of the liver
Any metabolic bone disease, e.g. osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings
Any symptomatic vertebral fracture within 3 months prior to screening
Previous participation in clinical trials with denosumab
Vitamin D deficiency \[25(OH) vitamin D level \< 20 ng/mL (\<49.9 nmol/L)\]
Contraindicated to alendronate therapy; contraindications for alendronate therapy include:
1. Abnormalities of the esophagus, which delay esophageal emptying such as stricture or achalasia.
2. Inability to stand or sit upright for at least 30 minutes.
3. Hypersensitivity to alendronate (ALN) or other constituents of ALN tablets.
Any known prior bisphosphonate use
Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trail (s), or subject is receiving other investigational agent(s).
