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| ID | Type | Description | Link |
|---|---|---|---|
| B3D-TW-GHCB |
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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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teriparatide 20 micrograms/day subcutaneous | Drug |
|
| |
| 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 the effect of teriparatide 20 micrograms/day with calcitonin 100 IU/day on change in biochemical bone markers (bone specific alkaline phosphatase[BSAP] and Osteocalcin) at 3 and 6 months after treatment with teriparatide versus calcitonin |
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Inclusion Criteria:
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.
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/GMT - 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) Mon-Fri from 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Changhua | Taiwan |
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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 |
| D002116 | 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 |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) Mon-Fri from 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Niao Sung Hsiang | Taiwan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) Mon-Fri from 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Taipei | Taiwan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) Mon-Fri from 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Taoyuan | Taiwan |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013963 | Thyroid Hormones |
| D009479 | Neuropeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |