Clinical trial: Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density (NCT00043186)

Eligibility criteria:
Inclusion Criteria

          -  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.

        Exclusion Criteria

          -  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)

          -  current hyper- or hypoparathyroidism

          -  albumin-adjusted serum calcium < 8.5 mg/dL (< 2.125 mol/L)

          -  osteomalacia

          -  rheumatoid arthritis

          -  Paget's disease

          -  malignancy within the 5 years before enrollment (except cervical carcinoma in situ or
             basal cell carcinoma, which were acceptable)

          -  renal disease; ie, creatinine clearance ≤ 35 mL/min

          -  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).
Female
No healthy subjects accepted to join the trial.

Subject must be at most 80 Years

Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? Entailment