Clinical trial: A Study of the Treatment of Postmenopausal Women With Osteoporosis (NCT00543023)

Eligibility criteria:
Inclusion Criteria:

          -  Ambulatory, postmenopausal women aged 55-85 years (at least 3 years have elapsed after
             menopausal) are included at the time of entry into the trial. They have to be free of
             severe or chronically disabling conditions other than osteoporosis.

          -  The patient should have a documented (X-ray) prevalent osteoporotic vertebral fracture
             or non-vertebral fragility fracture (excluding major trauma). Vertebral deformities
             will be evaluated on lateral views of the thoracic and lumbar spine. T-12 will be
             visible on both views so that all vertebrae from T-4 to L-4 can be identified. The
             radiographs will be performed according to a standardized protocol.

          -  L-1 through L-4 vertebrae must be without artifacts, multiple vertebral fractures;
             therefore at least 3 vertebrae should be without fractures, osteophytes, or other
             abnormalities that would interfere with the analysis of the posterior-anterior lumbar
             spine BMD measurement. The reading of the BMD, T-score should be in the range of - 2.0
             and - 4.0 at least for one of the 2 sites measured (spine or hip).

        The initial lumbar spine and femoral neck BMD assessment and the determination of the
        patient's eligibility for entry into the screening phase will be made by the central
        quality assurance for BMD. The central quality assurance center will determine the
        patient's eligibility for enrollment into the treatment phase. If the L-1 vertebra cannot
        be analyzed due to artifacts, vertebral fracture, osteophytes, or other abnormalities, that
        vertebra should be excluded from the analysis.

          -  Women without language barriers, cooperative and expected to return for all follow-up
             procedures and who have given informed consent before entering the study and after
             being informed of the risks, medications, and procedures to be used in the study.

          -  Normal or clinically insignificant abnormal laboratory values including serum calcium,
             PTH (1-84) levels and alkaline phosphatase.

        Exclusion Criteria:

          -  History of sprue, inflammatory bowel disease, or malabsorption syndrome in the 1 year
             prior to Visit 2.

          -  History of nephrolithiasis or urolithiasis in the 2 years prior to Visit 2. Patients
             with any history of nephro- or urolithiasis must have an appropriate radiology study
             within 6 months prior to Visit 2. This radiology study, such as an intravenous
             pyelogram or a supine radiograph of the kidney-ureter-bladder, must document the
             absence of active disease.

          -  History of other malignant neoplasms in the 5 years prior to screening, with the
             exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin
             that has been definitively treated. Patients with carcinoma in situ of the uterine
             cervix treated definitively more than 1 year prior to entry into the study may enter
             the study.

          -  Patients who have an increased baseline risk of osteosarcoma: Paget's disease of the
             bone or unexplained elevations of alkaline phosphatase; patients who have received
             radiation therapy involving the skeleton.

          -  History of diseases which affect bone metabolism other than postmenopausal
             osteoporosis such as Paget's disease, renal osteodystrophy, osteomalacia, any
             secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, or
             hyperthyroidism.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 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

Does the patient match the trial criteria? 1