Clinical trial: Bone Marker Changes With Teriparatide/Postmenopausal Osteoporosis (NCT00532545)

Eligibility criteria:
Inclusion Criteria:

          -  Presents with severe osteoporosis based on the disease diagnostic criteria and upon
             physician assessment

          -  Postmenopausal, nonpregnant, women older than 50 years of age, with previous fracture
             history such as hip, spine, wrist, ribs, clavicle, humerus, tibia, and fibula or men
             over 50 years of age with low impact fractures (fragility).

          -  Outpatients without concomitant diseases and with life expectancy of at least 3 years,
             according to the medical criteria.

          -  Cannot be on medicines that can disturb bone metabolism.

          -  Patients should be capable of self-injection, to learn the use of Pen device and are
             in agreement with its use.

        Exclusion Criteria:

          -  Directly affiliated with the conduct of this study, or are the immediate family of
             someone directly affiliated with the conduct of this study (that is, Lilly employees,
             investigators, site personnel, or their immediate families). Immediate family is
             defined as a spouse, parent, child, or sibling, whether biological or legally adopted.

          -  Received treatment within the last 30 days with a drug (not including study drug) that
             has not received regulatory approval for any indication at the time of study entry.

          -  Previously completed or withdrawn from this study or any other study investigating
             Teriparatide.

          -  Secondary osteoporosis or any disease that affects the bone metabolism, as renal
             osteodystrophy, osteomalacia, hypoparathyroidism, and hyperparathyroidism, and
             intestinal malabsorption.

          -  Cancer history in the 5 years prior to visit 1, with exemption of basocellular
             carcinoma treated and cervix carcinoma definitively treated at least 1 year before to
             visit 1
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 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