Clinical trial: Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis (NCT01732770)

Eligibility criteria:
Inclusion Criteria:

          -  Ambulatory postmenopausal women.

          -  Age 55 years or older

          -  Subject has provided informed consent prior to any study specific procedures

          -  Received oral bisphosphonate therapy for osteoporosis at least 2 years prior to
             screening visit

          -  Screening BMD (g/cm²) values at the lumbar spine, total hip or femoral neck values of
             equal to or less than those listed in the protocol.

          -  At least 2 lumbar vertebrae and one hip must be evaluable by dual energy x-ray
             absorptiometry (DXA) at the screening visit

        Exclusion Criteria:

          -  Received other osteoporosis treatment or bone active treatment

          -  Evidence of history of any of the following:

               -  hyperthyroidism (stable on antithyroid therapy is allowed)

               -  hypothyroidism (stable on thyroid replacement therapy is allowed)

               -  hypo- or hyperparathyroidism

               -  hypo- or hypercalcemia based on the central laboratory reference ranges

               -  Recent tooth extraction (within 6 months of screening visit)

               -  Paget disease of bone (subject report or chart review)

               -  other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis
                  imperfecta) (chart review)

          -  Abnormalities of the following per central laboratory reference ranges:

               -  vitamin D deficiency (25[OH] vitamin D level < 20 ng/mL), repletion will be
                  allowed and subjects may be re-screened

               -  hypercalcemia

               -  elevated transaminases ≥ 2.0 x upper limits of normal (ULN)

          -  History of any solid organ or bone marrow transplant

          -  Malignancy (except nonmelanoma skin cancers, cervical or breast ductal carcinoma in
             situ) within the last 5 years

          -  Known intolerance to calcium or vitamin D supplements

          -  Self-reported alcohol or drug abuse within 12 months prior to screening

          -  Currently receiving treatment in another investigational device or drug study, or less
             than 30 days since ending treatment on another investigational device or drug study(s)

          -  History or evidence of any other clinically significant disorder, condition or disease
             that in the opinion of the Investigator or Amgen physician, if consulted, would pose a
             risk to subject safety or interfere with the study evaluation, procedures or
             completion
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 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