Clinical trial: A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis (NCT03432533)

Eligibility criteria:
Inclusion Criteria:

          -  Subject has provided informed consent/assent prior to initiation of any studyspecific
             activities/procedures, or subject's legally acceptable representative has provided
             informed consent prior to any study-specific activities/procedures being initiated
             when the subject has any kind of condition that, in the opinion of the Investigator,
             may compromise the ability of the subject to give written informed consent.

          -  Postmenopausal female (postmenopausal status is defined as no vaginal bleeding or
             spotting for 12 consecutive months prior to screening)

             -≥ 55 to ≤ 90 years of age at the time of informed consent

          -  Ambulatory

          -  BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck, as assessed by
             the central imaging vendor at the time of screening, based on DXA scans -Subject has
             at least 2 vertebrae in the L1-L4 region evaluable by DXA, as assessed by the
             principal investigator or designee

          -  Subject has at least 1 hip evaluable by DXA, as assessed by the principal investigator
             or designee

          -  Subject has history of fragility (ie, osteoporosis-related fracture) or subject meets
             at least 2 of the following clinical risk factors for fracture

               -  ≥ 70 years of age at the time of informed consent

               -  BMD T-score ≤ -3.00 at the lumbar spine, total hip, or femoral neck, as assessed
                  by the central imaging vendor at the time of screening, based on DXA scans

               -  current smoker

               -  consumption of ≥ 3 glasses of alcohol a day

               -  parental history of fragility (ie, osteoporosis-related) fracture

               -  body weight ≤ 125 pounds/56 kilogram

          -  Ability to follow and understand instructions and the ability to self-inject, per
             investigator judgement

        Exclusion Criteria:

          -  History of osteonecrosis of the jaw and/or atypical femoral fracture

          -  History of metabolic or bone disease (except osteoporosis) that may interfere with the
             interpretation of the results, such as sclerosteosis, Paget's disease, rheumatoid
             arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing
             spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome

          -  Subject with reported history of hearing loss associated with cranial nerve VIII
             compression due to excessive bone growth (eg, as seen in conditions such as Paget's
             disease, sclerosteosis and osteopetrosis)

          -  Vitamin D insufficiency [defined as serum 25 (OH) vitamin D levels < 20 ng/mL], as
             determined by the central laboratory. Vitamin D repletion will be permitted a nd
             subjects may be rescreened

          -  Current hyperthyroidism (unless well controlled on stable antithyroid therapy) by
             subject report or by chart review, per principal investigator evaluation

          -  Current clinical hypothyroidism (unless well controlled on stable thyroid replacement
             therapy) by subject report or by chart review, per principal investigator evaluation
             normal range, per subject medical history. Uncontrolled hyperparathyroidism is defined
             as: parathyroid hormone (PTH) outside the normal range in subjects with concurrent
             hypercalcemia; or PTH values > 20% above the upper limit of normal (ULN) in
             normocalcemic subjects.

          -  Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the
             normal range, as assessed by the central laboratory. Serum calcium levels may be
             retested once in case of an elevated serum calcium level within 1.1x the ULN as
             assessed by the central laboratory
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 90 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