Clinical trial: Study of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis (NCT00532207)

Eligibility criteria:
Inclusion Criteria:

          -  Are postmenopausal women at least 55 years old and at least 2 years postmenopausal at
             the time of entry into the trial, and who have given informed consent before entering
             the study and after being informed of the risks, medications, and procedures to be
             used in the study. In addition, women below the age of 60 years with indeterminate
             menopause due to premenopausal hysterectomy must have their postmenopausal status
             confirmed with a serum FSH level > 30 IU/L.

          -  Posterior-anterior lumbar spine (L1-L4) BMD and/or femoral neck BMD measurement at
             least < 2.5 standard deviation (SD) from the mean of healthy, pre-menopausal women.

          -  Results of lumbar BMD (L1-L4) measurement must be available. The initial lumbar spine
             assessment and the determination of the patient's eligibility for entry into the
             screening phase will be made by the individual investigator. If the L-1 vertebra
             cannot be analyzed due to artifact, vertebral fracture, osteophytes, or other
             abnormalities, that vertebra should be excluded from the analysis.

          -  Normal or clinically insignificant abnormal laboratory values (as defined by the
             investigator) including serum calcium, 25 hydroxyvitamin D levels and alkaline
             phosphatase.

          -  Willing to be trained on and use a pen type injection delivery system on a daily basis
             for 12 months.

        Exclusion Criteria:

          -  Active liver disease - liver enzymes (ALT, AST) more than three times the upper normal
             range, or a bilirubin of > 2.0 mg/dl, or clinical jaundice.

          -  Abnormal thyroid function not corrected by therapy. Normal thyroid function will be
             documented by a normal TSH during screening phase

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

          -  History of malignant neoplasms within 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.

          -  Current pharmacological treatment for osteoporosis, other than calcium and Vitamin D

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