Clinical trial: A Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis (NCT04757376)

Eligibility criteria:
Inclusion Criteria:

          1. Women, 50 to 80 years of age, both inclusive.

          2. Body weight between 40.0 and 99.9 kg, both inclusive, when rounded to the nearest
             tenth.

          3. Postmenopausal

          4. Bone mineral density T-score ≤ - 2.5 and ≥ - 4.0 at the lumbar spine (L1 to L4) as
             assessed by the central imaging vendor based on dual-energy X-ray absorptiometry(DXA)
             scan.

          5. Patients must have at least 3 vertebrae considered evaluable at the lumbar spine (L1
             to L4) and at least 1 hip considered evaluable by DXA scan assessed by the central
             imaging vendor. Patients with unilateral metal in hips that would be allowed for the
             other side of 1 evaluable hip are included.

          6. Patient with albumin-adjusted total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) at
             Screening.

        Exclusion Criteria:

          1. Patient with a hypersensitivity to any component of denosumab or dry natural rubber.

          2. Patient with history and/or presence of one severe or > 2 moderate vertebral fractures
             as determined by central reading of lateral spine X-ray

          3. Patient with history and/or presence of hip fracture

          4. Patient with history and/or presence of hyperparathyroidism or hypoparathyroidism,
             irrespective of current controlled or uncontrolled status

          5. Patient with current hyperthyroidism (unless well controlled on stable antithyroid
             therapy)

          6. Patient with current hypothyroidism (unless well controlled on stable thyroid
             replacement therapy)

          7. Patient with history and/or presence of bone disease and metabolic disease (except for
             osteoporosis) that may interfere with the interpretation of the results

          8. Patient with history and/or concurrent use of any osteoporosis treatment (other than
             calcium and vitamin D supplements), oral or parenteral glucocorticosteroids, any bone
             active drugs, and any investigational drug
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
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