Clinical trial: 2-Year Therapy With Teriparatide vs 1-yr Therapy Followed by 1-Year of Raloxifene or Calcium/Vit D in Severe Postmenopausal Osteoporosis (NCT00191425)

Eligibility criteria:
Inclusion Criteria:

          -  Ambulatory women greater or equal to 55 years, at least 2 years postmenopausal.

          -  Lumbar spine or total hip or femoral neck bone mineral density measurement must be at
             least 2.5 standard deviations (SD) below the average bone mass for young women
             (T-score -2.5 or less).

          -  Presence of at least one known and documented preexisting clinical fragility fracture,
             in the past 3 years.

        Patients may be included in substudy 2 if they meet any one of the following additional
        criteria - Patients who have sustained at least one new fragility fracture (vertebral or
        nonvertebral), despite prescription of antiresorptive therapy* during the 12 months prior
        to the last new fracture or patients who, after a minimum of two years after initiating
        antiresorptive therapy*, either have a lumbar spine, femoral neck, or total hip BMD of at
        least - 3SD below the average bone mass for young women (T-score -3 or less), or who show a
        decrease of at least 3.5% in BMD at any one of these sites.

        *Antiresorptive therapy includes all bisphosphonates, raloxifene, ERT/HRT, calcitonin, and
        vitamin D metabolites.

        Exclusion Criteria:

        For substudy 1 patients only:

          -  current or history of vaginal bleeding or spotting of unknown cause in the 1 year
             prior to study start

          -  currently suspected or history of venous thrombotic events (VTE), including lower
             extremity thrombosis, and other major venous thromboses, or high risk of developing
             VTE as assessment by the investigator.

        Treatment with

          -  Vitamin D >50,000 IU/week or with any dose of calcitriol or vitamin D analogs or
             agonists in the 6 months prior to visit 2

          -  Fluorides in the 12 months prior to visit 2.

          -  Systemic corticosteroids (other than for replacement therapy) in the 1 month prior to
             visit 2.(Ophthalmic, otic topical, orally inhaled, nasally inhaled, or intra-articular
             corticosteroid therapy may be used without these restrictions.)
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