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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019297-32 | EudraCT Number |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The purpose of this study is to analyse efficacy of teriparatide treatment in patients with new forms of inherited low-turnover osteoporosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| teriparatide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | Daily administration of teriparatide 20 ug s.c. for 24 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in lumbar bone mineral density (BMD) | The primary outcome measure is the change in lumbar BMD measured with dual-energy X-ray absorptiometry (DXA) during the 24 months treatment period. | 0, 12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in whole body bone mineral density (DXA) | 0,12 and 24 months | |
| Change from baseline in hip bone mineral density (DXA) | 0,12 and 24 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matti Välimäki, MD,PhD | Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopaedics and Traumatology and Division of Endocrinology, Department of Medicine and Pediatric Endocrinology, Hospital for Children and Adolescents, Helsinki University Central Hospital | Helsinki | FI-00029 HUS | Finland |
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| ID | Term |
|---|---|
| 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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| Change from baseline in histomorphometry of bone biopsy samples |
includes e.g following parameters: Bone volume (BV/TV, %); Osteoid volume (OV/BV, %); Trabecular thickness (Tb.Th, um); Osteoid surface (OS/BS, %); Osteoblast surface (Ob.S/BS, %); Eroded surface (ES/BS, %); Osteoclast surface (Oc.S/BS, %); Mineral apposition rate (MAR, um/day); Mineralizing surface (MS/BS, %) |
| 0 and 24 months |
| Change from baseline in bone microarchitecture assessed by micro computed tomography of bone biopsy samples | includes e.g following parameters: bone volume (BV, mm3); relative bone volume (BV/TV, %); connectivity density, (Conn.D., 1/mm3); trabecular number (DT-Tb.N, 1/mm); trabecular thickness (DT-Tb.Th, mm) | 0 and 24 months |
| Change from baseline in peripheral quantitative computed tomography (pQCT) measured cortical and trabecular volumetric bone mineral density of tibia and radius | 0,12 and 24 months |
| Number of vertebral fractures (spine X-ray) | 24 months |
| Change from baseline in serum procollagen type I N-terminal propeptide (PINP) | 0,3,6,12 and 24 months |
| Change from baseline in serum type I collagen C-telopeptides (CTX) | 0,3,6,12 and 24 months |
| Change from baseline in serum osteocalcin | 0,3,6,12 and 24 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |