A Study of the Treatment of Postmenopausal Women With Osteoporosis

Study Overview
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Brief Summary
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To compare the effect of treatment with teriparatide with that of salmon calcitonin in postmenopausal women with osteoporosis.

Official Title
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Comparison of Teriparatide and Calcitonin in the Treatment of Postmenopausal Women With Osteoporosis

Conditions
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Osteoporosis, Post-Menopausal

Intervention / Treatment
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* Drug: teriparatide 20 micrograms/day subcutaneous
* Drug: salmon calcitonin 100 IU/day subcutaneous


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>teriparatide 20 micrograms/day subcutaneous | Drug: teriparatide 20 micrograms/day subcutaneous<br> <br> * Other names: LY333334;|
| Active Comparator: B<br>salmon calcitonin 100 IU/day subcutaneous | Drug: salmon calcitonin 100 IU/day subcutaneous<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare the effect of treatment with teriparatide 20 micrograms/day subcutaneous with that of salmon calcitonin 100 IU/day subcutaneous on change in lumbar spine BMD in postmenopausal women with established osteoporosis. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare the effect of treatment with teriparatide 20 micrograms/day with that of calcitonin 100 IU/day on change in femoral neck and total hip BMD in postmenopausal women with established osteoporosis |  |  | 
| to compare the effect of treatment with teriparatide 20 micrograms/day with that of calcitonin 100 IU/day on change in biochemical bone markers (bone specific alkaline phosphatase [BSAP] and Osteocalcin) at 3 and 6 months |  |  | 
| to assess safety as determined by physical examination, vital signs, clinical laboratory data and reports of adverse events. |  |  |