Clinical trial: Post-menopausal Women Osteoporosis(Phase III) (NCT01806792)

Eligibility criteria:
Inclusion Criteria:

          1. women osteoporosis

          2. patients with a diagnosis of Postmenopausal over 6 Months if they had a bone mineral
             density T-score of < -2.5 at the mean lumbar spine (L1-4), femoral neck, or total, or
             a T-score of < -1.0 with radiologic evidence of at least one vertebral fracture.
             Menopause was defined as no natural menses for at least 1 year and a serum FSH level >
             40 IU/L, with a reported hysterectomy

          3. low levels of 25(OH)D > 9 ng/mL

          4. patients who give written consent of agreement to voluntarily participate in the
             clinical study

          5. patients who can read and understand written instructions

        Exclusion Criteria:

          1. patients who had contraindications to oral bisphosphonates, such as esophageal
             strictures

          2. ALT, AST ≥ 2×UNL and Serum Creatinine ≥ 1.5×UNL

          3. low levels of 25(OH)D (less than 9 ng/mL).

          4. Previous use of oral bisphosphonates and vitamin D were allowed, but a washout period
             was needed, depending on the duration of treatment. Two-year washout periods were
             needed for bisphosphonate users and 3-6-month periods were required for vitamin D
             users of > 200 IU.

          5. drug administration after diagnosing as alcoholic or psychical disease

          6. patients whom the investigators judge as improper to participate in this clinical
             trial 7)13.patients who have experience to participate in other clinical trial within
             30 days prior to study participation
Female
No healthy subjects accepted to join the trial.



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