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This study is being conducted to compare the effect of increasing nasal teriparatide dosing on percent change in Bone Mineral Density (BMD) of the lumbar spine after 24 weeks of therapy in postmenopausal women with low bone mineral density.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
| |
| 5 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | 20ug subcutaneous injection daily for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in bone mineral density of the lumbar spine from baseline to 24 weeks post treatment. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in bone mineral density from baseline to 12 weeks post treatment | 12 weeks | |
| Safety, including hypercalcemia and nasal effects | 24 weeks | |
| Change from baseline in bone markers PINP and CTX from baseline to 4, 12 and 24 weeks post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gordon Brandt, MD | Nastech Pharmaceutical Company, Inc. | Study Director |
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| Teriparatide Nasal Spray | Drug | teriparatide intranasally daily for 24 weeks |
|
| Teriparatide Nasal Spray | Drug | teriparatide intranasally daily for 24 weeks |
|
| Teriparatide Nasal Spray | Drug | teriparatide intranasally daily for 24 weeks |
|
| Teriparatide Nasal Spray | Drug | teriparatide intranasally daily for 24 weeks |
|
| 4, 12 and 24 weeks |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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