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This study is being conducted to evaluate the effect treatment has on serum P1NP levels, a biomarker of bone formation in postmenopausal women with low bone mass.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Nasal Spray | Experimental |
| |
| Mid Dose Nasal Spray | Experimental |
| |
| High Dose Nasal Spray | Experimental |
| |
| Forteo | Active Comparator | 20ug subcutaneous injection daily |
|
| Placebo Nasal Spray | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZT-034 Low Dose Nasal Spray | Drug | Nasal Spray |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum P1NP from baseline to end of treatment. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose) | baseline and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian MacDonald | Azelon Pharmaceuticals | Study Director |
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| ZT-034 Mid Dose Nasal Spray |
| Drug |
Nasal Spray |
|
| ZT-034 High Dose Nasal Spray | Drug | Nasal Spray |
|
| Teriparatide | Drug | 20 mcg subcutaneous daily |
|
|
| Placebo | Drug | Nasal Spray |
|
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059085 | Nasal Sprays |
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| 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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