Clinical trial: Comparison Study of PTHrP and PTH to Treat Osteoporosis (NCT00853723)

Eligibility criteria:
Inclusion Criteria:

          -  45 - 75 year old Caucasian, Hispanic or Asian women

          -  one year post-menopausal if older than 50 years

          -  three years post-menopausal if between the ages of 45 - 50 years

          -  body mass index less than or equal to 30

          -  T-scores on screening Dual X-Ray Absorbiometry (DXA) scan between - 2.0 to - 4.5 of
             lumbar spine or hip

          -  have at lease two spinal vertebrae evaluable by DXA analysis

        Exclusion Criteria:

          -  bisphosphonate therapy within the last two years

          -  estrogen replacement hormones or SERMS within last one year

          -  no more than one week of PTHrP, PTH, or an analog of PTH within the last year

          -  an atraumatic bone fracture within the last 6 months

          -  significant or active diseases of any organ system

          -  history of malignancy

          -  anemia with a hematocrit less than 34%

          -  significant drug or alcohol abuse

          -  having received any investigational drug within the last 90 days

          -  taking any medication that may interfere with skeletal metabolism, such as
             phenobarbital, dilantin, glucocorticoids, and hydrochlorathiazide

          -  abnormal screening labs including serum Ca greater than 10.5 g/dl, 25 hydroxy vitamin
             D less than 20 ng/ml or PTH greater than 65 pg/ml

          -  African-Americans for this particular study - although future studies are planned
Female
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
Subject must be at most 75 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? Entailment