Clinical trial: Denosumab Adherence Preference Satisfaction Study (NCT00518531)

Eligibility criteria:
Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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).
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.


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

Does the patient match the trial criteria? 1