Clinical trial: Teriparatide for Fracture Repair in Humans (NCT02091492)

Eligibility criteria:
Inclusion Criteria:

          -  recent proximal 2-segment humerus fracture (0-8 days post fracture)

          -  no surgical treatment at fractured site

          -  signed informed consent

          -  postmenopausal female and male patients aged 60 - 85 years

          -  established osteoporosis as defined by BMD measured with DXA-technology (dual energy
             X-ray absorptiometry) with a T-score ≤ -2.0 spine or hip

        Exclusion Criteria:

          -  Hypersensitivity to the active substance or to any of the excipients.

          -  Pre-existing hypercalcemia

          -  Severe renal impairment (eGFR< 35ml/min)

          -  Metabolic bone diseases (including hyperparathyroidism and Paget's disease of the
             bone) other than primary osteoporosis or glucorticoid-induced osteoporosis.

          -  Unexplained elevations of alkaline phosphatase

          -  Prior external beam or implant radiation therapy to the skeleton

          -  Patients with skeletal malignancies or bone metastases should be excluded from
             treatment with teriparatide.

          -  any prior antiresorptive therapy (oral/intravenous bisphosphonates, RANKL-antibody,
             SERMs)

          -  any prior strontium ranelate therapy

          -  any prior TPTD of PTH 1-84 therapy

          -  malignancies ≤ 5 years except basalioma

          -  hypo-/hypercalcemia

          -  baseline 25-OH vitamin D3 level ≤10 ng/ml

          -  prosthesis at fractured and contralateral humerus
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 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? Contradiction