A Study of the Treatment of Postmenopausal Women With Osteoporosis
A Study of the Treatment of Postmenopausal Women With Osteoporosis
To compare the effect of treatment with teriparatide with that of salmon calcitonin in
 postmenopausal women with osteoporosis.
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.