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Eli Lilly has withdrawn support to the study of teriparatide and placebo pens. The study was not able to continue as a randomized study without the supply of placebo pens.
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Osteogenesis imperfecta (OI) is an inherited disease of the connective tissue. Symptoms are fractures, growth retardation, blue sclera, bad teeth, impaired hearing a.o. The aim of the present study is to investigate the effect of treatment of adult OI patients with bisphosphonate (zoledronic acid), parathyroid hormone (PTH) or placebo on bone mass, fracture risk and quality of life.
The investigators will therefore conduct a double blind, placebo controlled trial, taking genotype and previous antiresorptive therapy into account.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zolendronic acid, 3 yr + placebo teriparatide, 2 yr | Experimental | yearly intravenous infusion of 5mg active zoledronic acid in 3 yr |
|
| teriparatide 2 yr; active zol in 3rd yr | Experimental | daily injection of one dose active teriparatide for two years, active zoledronic acid in year 3. |
|
| No active treatment | Placebo Comparator | Observation in three years, no treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic acid | Drug | antiresorptive and calcium and vitamin D |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density (BMD) | Dual-energy X-ray absorptiometry scans are performed at the lumbar spine, hip and whole body twice yearly. The value of the lumbar BMD is the primary outcome. | Three years |
| Measure | Description | Time Frame |
|---|---|---|
| Fracture risk | Participants are asked to report fractures throughout the study. Medical examination yearly with a focus on possible new fractures. Columnar x-ray before and after the study investigate new fractures. | Three years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bente Langdahl, MD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osteoporosis clinic; department of endocrinology and metabolism | Aarhus | Aarhus C | 8000 | Denmark | ||
| Department of endocrinology |
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| ID | Term |
|---|---|
| D010013 | Osteogenesis Imperfecta |
| ID | Term |
|---|---|
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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|
| Teriparatide | Drug | anabolic and calcium and vitamin D |
|
|
| No active treatment | Other | Calcium and vitamin D |
|
| Hvidovre |
| 2650 |
| Denmark |
| Department of Endocrinology M | Odense | 6000 | Denmark |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |