Clareo Health | Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
0–80
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
women not more than 80 years of age on date of randomization
≥ 1 year postmenopausal on date of randomization
ambulatory
if ≤ 60 years of age, or had or would require a bilateral oophorectomy, serum follicle stimulating hormone (FSH) \> 50 mU/mL or serum estradiol \< 20 pg/mL
low BMD (BMD T-score ≤ -1.8 at any 1 of the following sites: lumbar spine, femoral neck, or total hip; BMD T-scores must not have been \< -4.0 at the lumbar spine or - 3.5 at the femoral neck or total hip)
before any study-specific procedure, including the screening dual X-ray absorptiometry (DXA) scan, gave informed consent for participation in the study.
You may not be if
fluoride treatment for osteoporosis within the 2 years before the enrollment date
bisphosphonate use within the 12 months before the enrollment date
administration of the following medications within the 6 months before the enrollment date
* tibolone
* Parathyroid hormone (PTH) (or any derivative)
* systemic glucocorticosteroids (\> 5 mg oral prednisone equivalent per day for \> 10 days)
* inhaled corticosteroids (\> 2000 μg per day for \> 10 days)
* anabolic steroids or testosterone
administration of the following medications within the 3 months before the enrollment date
* systemic hormone replacement therapy
* selective estrogen receptor modulators
* calcitonin
* calcitriol
current hyper- or hypothyroidism (allowed if stable on thyroid replacement therapy and thyroid-stimulating hormone was within the normal range)
any bone disease, other than osteoporosis, which could interfere with the interpretation of the findings (eg, osteogenesis imperfecta or osteopetrosis)
malabsorption syndrome
weight, height, or girth that could preclude accurate DXA measurements
\< 2 lumbar vertebrae (L1 through L4) evaluable by DXA
recent long bone fracture (within 6 months)
osteoporotic-related fracture (ie, crush or wedge vertebral fracture or hip fracture) known or suspected to have occurred within 2 years of randomization
\> 1 single, grade 1 vertebral fracture
currently enrolled in or had participated within the previous 30 days in other investigational device or drug trial(s) (For some trials, this may have been allowed after discussion and written approval from Amgen.)
known sensitivity to mammalian-derived drug preparations (eg, Herceptin®)
any organic or psychiatric disorder, serum chemistry, or hematology that, in the opinion of the investigator, could have prevented the subject from completing the study or have interfered with the interpretation of the study results
self-reported alcohol or drug abuse within the previous 12 months
any disorder that compromised the ability to give truly informed consent for participation in the study
previous administration of denosumab
known sensitivity or contraindication to alendronate
known sensitivity or contraindication to tetracycline derivatives (subjects in the biopsy substudy only).
