Clinical trial: Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis (NCT00343252)

Eligibility criteria:
Inclusion Criteria:

          -  Postmenopausal women 45 years or older. No period for at least two years.

          -  History of back pain that started at least 2 months prior to the initial visit (likely
             due to spinal bone fracture determined by investigator).

          -  Minimum of one moderate spinal bone fracture.

          -  Beginning pain level of at least four on an eleven point scale.

          -  Bone Mineral Density (BMD) must meet criteria

          -  Able to read, understand, and administer self-questionnaires.

          -  Be willing and able to use a pen-injector to deliver the medication.

        Exclusion Criteria:

          -  Are at increased risk for osteosarcoma.

          -  Have an active or suspected diseases that affects bone metabolism other than
             osteoporosis.

          -  Participants that already know that they will require procedures to repair their
             spinal bone fractures.

          -  Abnormal values of certain lab tests.

          -  Anything that would make it difficult to determine if the back pain was due to the
             fracture.

          -  Poor medical or psychiatric condition.

          -  Alcohol or drug abuse within a year of the study start.

          -  Certain malignant neoplasms in the 5 years prior to enrollment.

          -  Active liver disease or clinical jaundice.

          -  Significantly impaired renal function.

          -  History of nephrolithiasis or urolithiasis within 2 years prior to enrollment.

          -  Known contraindication or intolerance to risedronate and/or teriparatide therapy.

          -  Treatment with oral strontium or certain therapeutic doses of fluoride.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 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? Contradiction