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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015933-64 | EudraCT Number |
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This study is designed to provide information about the bone-anabolic response of PTH134 when administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide, the active ingredient in PTH134.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTH134 | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Forsteo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTH134 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Measure: Effects of treatment on bone biomarkers. Measure levels of PINP, CTX-1, and serum calcium levels, serum phosphate, P1CP, bone-specific alkaline phosphatase, osteocalcin. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in serum calcium levels after 12 weeks of treatment | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Aalborg | Denmark | ||||
| Novartis Investigative Site |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | 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 |
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|
| Forsteo | Drug |
|
| Ballerup Municipality |
| Denmark |
| Novartis Investigative Site | Berlin | Germany |
| Novartis Investigative Site | Munich | Germany |
| D009750 |
| Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |