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| ID | Type | Description | Link |
|---|---|---|---|
| B3D-KL-GHCC |
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To compare in postmenopausal women with established osteoporosis the effect of treatment with teriparatide 20 micrograms/day subcutaneous with the effect of salmon calcitonin 100 IU/day subcutaneous on change in lumbar spine BMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | teriparatide 20 micrograms/day subcutaneous |
|
| B | Active Comparator | salmon calcitonin 100 IU/day subcutaneous |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teriparatide 20 micrograms/day subcutaneous | Drug |
|
| |
| salmon calcitonin 100 IU/day subcutaneous |
| Measure | Description | Time Frame |
|---|---|---|
| To compare in postmenopausal women with established osteoporosis the effect of treatment with teriparatide 20 micrograms/day subcutaneous with the effect of salmon calcitonin 100 IU/day subcutaneous on change in lumbar spine BMD. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare in postmenopausal women with established osteoporosis the effect of treatment with teriparatide 20 micrograms/day with the effect of calcitonin 100 IU/day on change in femoral neck and total hip BMD | ||
| Compare effect of teriparatide 20 micrograms/day with the effect of calcitonin 100 IU/day on change in biochemical bone markers (bone specific alkaline phosphatase and Osteocalcin) at 3 and 6 months after treatment with teriparatide versus calcitonin. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMY - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Seoul | South Korea |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| C028815 | salmon calcitonin |
| D007279 | Injections, Subcutaneous |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Drug |
|
| Safety as determined by physical examinations, vital signs, clinical labs and reports of adverse events |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |