Clinical trial: Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women (NCT00927186)

Eligibility criteria:
Inclusion Criteria:

          -  Ambulatory, postmenopausal women with osteoporosis (no vaginal bleeding for at least 2
             years prior to trial entry)

          -  Free of severe or chronically disabling conditions other than osteoporosis that will
             impair ability to complete the trial

          -  Bone mineral density (BMD) T-score of at least -2.5 at the femoral neck, total hip, or
             lumbar spine (L1-L4, with at least 2 evaluable vertebrae), with or without atraumatic
             fracture or,

          -  Bone mineral density (BMD) T-score of at least -1.5 at the femoral neck, or total hip,
             or lumbar spine (L1-L4, with at least 2 evaluable vertebrae), and either 1 or more
             atraumatic vertebral fracture(s) or an atraumatic nonvertebral fracture in the opinion
             of the investigator. Nonvertebral fracture sites allowed are wrist, hip, pelvis, ribs,
             humerus, clavicle, leg (femur, tibia, and fibula, excluding the ankle).

          -  Serum calcium, parathyroid hormone (PTH), alkaline phosphatase must be within normal
             reference range

        Exclusion Criteria:

          -  Have an increased risk of osteosarcoma (bone tumor); this includes Paget's disease of
             bone, a previous bone tumor, or radiation involving the skeleton

          -  Are allergic or cannot tolerate teriparatide or zoledronic acid or any of their
             ingredients or components

          -  Are allergic to tetracycline

          -  Have a history of exposure to tetracycline therapy in the 3 months prior to trial
             entry

          -  Have participated in a prior PTH clinical trial or received prior treatment with
             teriparatide, PTH, or other related medications

          -  Have a vitamin D level below 10 nanogram/milliliter (ng/mL)

          -  Have a condition that could possibly put one at risk for an adverse event due to the
             bone biopsy procedure (e.g. bleeding disorder)

          -  Have undergone two previous iliac crest bone biopsies (one in each iliac crest)

          -  Have taken any intravenous (IV) osteoporosis medication

          -  Have taken other oral osteoporosis medications and have not been off of them for a
             specific period of time before trial entry

          -  Have a history of certain cancers in the 5 years prior to trial entry

          -  Have active liver disease

          -  Have significantly impaired kidney function

          -  Currently have active or suspected diseases that affect the bones, other than
             osteoporosis

          -  Have active or recent history of significant gastrointestinal (stomach or intestinal)
             disorders

          -  Have been treated with certain glucocorticoids for more than 30 days in the past 1
             year prior to trial entry
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 89 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