Clinical trial: A Study of Arzoxifene to Treat Korean Women With Osteoporosis (NCT00767299)

Eligibility criteria:
Inclusion Criteria:

          -  Present with osteoporosis based on total hip, femoral neck or lumbar spine BMD T-score
             of less than or equal to -2.5 but must never have had any osteoporotic fragility
             fracture.

          -  Are ambulatory and are 60 to 85 years of age, inclusive. Aside from diagnosed
             osteoporosis (Inclusion Criterion [1]), all women must be free of severe or
             chronically disabling conditions, have a life expectancy of at least 5 years in the
             opinion of the investigator, be expected to remain ambulatory throughout the entire
             study, and be expected to return for follow-up visits.

          -  Had their last natural menstrual period at least 2 years before beginning the study.

          -  Are able to comprehend the requirements and procedures for the study and to provide
             informed consent before entering the study.

          -  Have at least two lumbar vertebrae (L1 to L4) that are evaluable via dual energy X-ray
             absorptiometry (DXA) and lateral thoracic and lumbar spine x-ray films that can be
             adequately evaluated for existing vertebral fractures at screening.

          -  Have centrally read total hip, femoral neck or lumbar spine T-score less than or equal
             to -2.5

        Exclusion Criteria:

          -  Have known current metabolic bone disorders other than low bone mass, such as
             hyperparathyroidism, renal osteodystrophy, or osteomalacia.

          -  Have known, suspected, or history of carcinoma of the breast or estrogen-dependent
             neoplasia (e.g., endometrial or uterine carcinoma), except for hysterectomized
             patients with a history of carcinoma in situ of the uterus. For other cancers, be
             disease free and in remission from all other cancers for 5 or more years, except for
             excised superficial lesions, such as basal cell carcinoma or squamous cell carcinoma
             of the skin.

          -  Have demonstrated or suspected allergy to raloxifene or arzoxifene

          -  Have unexplained or abnormal vaginal bleeding within 6 months prior to Visit 1 or
             between Visit 1 and Visit 2.

          -  Are experiencing clinically severe postmenopausal symptoms that may require
             estrogen-replacement therapy.

          -  Have a history of or suggestion on ultrasound or pelvic examination of a pre-existing
             gynecologic abnormality that would require further gynecologic treatment (e.g.,
             ovarian cysts, large fibroids, undiagnosed adnexal masses) or of baseline endometrial
             thickness of >5 mm.

          -  Have Papanicolaou's tests showing malignant or premalignant findings.

          -  Have active or any past history of thromboembolic events

          -  Have active or any past history of atrial fibrillation.

          -  Have a history of cerebrovascular accident or documented transient ischemic attack at
             any time in the past.

          -  Have acute or chronic liver disease defined as alanine aminotransaminase (ALT) >100
             U/L, gamma-glutamyl transferase (GGT) >400 U/L, or late stage cirrhosis without
             transaminase elevations.

          -  Have impaired kidney function (serum creatinine >177 micromol/L or >2.0 mg/dL).

          -  Have vitamin D deficiency prior to enrollment (Visit 2; 25-hydroxyvitamin D less
             than10 ng/mL or less than 24.9 nmol/L).

          -  Have any known, severe, or untreated malabsorption syndromes.

          -  Have endocrine disorders requiring pharmacologic therapy except for type II diabetes
             and hypothyroidism. Patients on a stable dose of thyroid replacement therapy during
             the 6 months preceding randomization (Visit 2) who are clinically euthyroid in the
             opinion of the investigator may enroll in the trial.

          -  Consume an excess of alcohol or abuse drugs

          -  Represent an unacceptable medical or psychiatric risk for treatment with an
             investigational drug

          -  Have active or any history of seizure disorder.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 85 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? Contradiction