Clinical trial: Back Pain in Patients With Severe Osteoporosis (NCT00761332)

Eligibility criteria:
Inclusion Criteria:

          -  Men and postmenopausal women who have a previous vertebral osteoporotic fracture that
             was sustained at least 6 weeks prior to joining the study.

          -  Patients who are free of severe or chronically disabling conditions other than
             osteoporosis.

          -  Patients who are not currently receiving and have not previously received
             teriparatide.

          -  Patients who agree to participate, return to follow-up visits, and who have signed
             informed consent to participate in the study.

          -  Patients, who in the opinion of the prescribing physician, are eligible to receive the
             intended treatment and comply with all the recommendations stated in the relevant
             product information.

        Exclusion Criteria:

          -  Are investigator site personnel directly affiliated with the study and/or their
             immediate families. Immediate family is defined as a spouse, parent, child, or
             sibling, whether biological or legally adopted.

          -  Are Lilly employees (that is, employees, temporary contract workers, or designees
             responsible for conducting the study). Immediate family of Lilly employees may
             participate in Lilly-sponsored clinical trials, but are not permitted to participate
             at a Lilly facility.

          -  Patients who have any contraindications according to the relevant product information
             in the country in which they are being treated.

          -  Patients who are simultaneously participating in a different study that includes a
             treatment intervention and/or an investigational drug.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 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