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| ID | Type | Description | Link |
|---|---|---|---|
| B3D-IT-B014 | Other Identifier | Eli Lilly and Company |
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This observational study will evaluate the incidence of new vertebral and non vertebral fragility fractures in patients with severe osteoporosis treated with anabolic drugs. This study will also evaluate BMD, compliance to treatment, back pain and the health-related quality of life.
The participants should be treated with anabolic therapy for osteoporosis (Teriparatide or PTH 1-84) for 18 months and should be followed up for subsequent 6 months. The treatment is expected to improve bone mineral density, back pain and reduce the risk of new fractures due to osteoporosis. The outcomes will be evaluated by bone densitometry at the lumbar spine and femoral neck, by standard radiographs, by measurements of bone formation marker (P1NP) and by questionnaires on back pain and quality of life. Postmenopausal women and men over 21 years old may be included if they have:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with severe osteoporosis | Postmenopausal women and men aged > 21 years old affected by severe osteoporosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | 20 mcg daily subcutaneous for 18 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of any osteoporotic fractures in the first 24 months from the initiation of anabolic medication. | From 0 to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment compliance | From 0 to 24 months | |
| Reason of discontinuation | From 0 to 24 months | |
| BMD changes (lumbar and femoral BMD) |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM 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 study, 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. | Valeggio sul Mincio | Verona | 36067 |
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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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| From 0 to 24 months |
| Changes in bone turnover marker measured by P1NP | From 0 to 24 months |
| Quality of Life (measured by EQ-5D of EuroQol Group) | From 0 to 24 months |
| Back Pain measured by visual analogue scale and back pain questionnaire | From 0 to 24 months |
| Assessment of motor performance and chair rising test | From 0 to 24 months |
| Italy |
| D009750 |
| Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |