Clinical trial: Combined Administration of Teripapartide and Antiresorptive Agents in Postmenopausal Osteoporosis (NCT01535027)

Eligibility criteria:
Inclusion Criteria:

          -  Ambulatory postmenopausal women at least 55 years of age

          -  Patients with "unsatisfactory clinical response to previous antiresorptive therapy"
             according to the national reimbursement criteria of Austria (either new clinical or
             radiographic fragility fracture on ≥ 2 years and/or accelerated bone loss of ≥
             3.5%/year on antiresorptive treatment; discontinuation of oral antiresorptive
             treatment due to side-effects and substantial risk for osteoporotic fracture defined
             by a T-Score ≤ -2.5 or ≥ 2 clinical risk factors according to the FRAX™-algorithm)and
             consequently started with teriparatide treatment

          -  Patients treated with teriparatide (20 ug/day) currently and since 9 months for
             postmenopausal osteoporosis

          -  Lumbar spine, femoral neck, and total hip evaluable by dual energy x ray
             absorptiometry (DXA)

          -  Normal or clinically non-significant abnormal laboratory values (as defined by the
             investigator)

          -  Without language barrier, cooperative, expected to return for all follow-up
             procedures, and who give informed consent before entering the study and after being
             informed of the medications and procedures to be used in this study

        Exclusion Criteria:

          -  History of bone metabolic diseases, Paget's disease, renal osteodystrophy,
             osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected),
             and intestinal malabsorption

          -  History of malignant neoplasms in the prior 5 years, with the exception of superficial
             basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively
             treated. If malignant neoplasm was ever diagnosed, patient must presently be free of
             disease

          -  History of nephrolithiasis or urolithiasis in the prior 2 years. Patients with any
             documented history of nephro- or uro-lithiasis must have had an appropriate imaging
             procedure within the prior 6 months, such as, an intravenous pyleogram (IVP), supine
             radiograph of the kidney ureter bladder, or renal ultrasound, which must document the
             absence of stones

          -  Abnormal thyroid function at any time in the prior 6 months. Patients with chronic
             hypothyreosis and adequate substitution therapy are permitted

          -  Active liver disease (liver enzymes more than three times the upper limit of normal)
             or clinical jaundice

          -  Significantly impaired renal function. This is defined as serum creatinine >1.8 mg/dL

          -  Treatment with bone active agent other than teriparatide in the prior 9 months
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 88 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? 0