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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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Hypothesis:
The investigators want to study whether parathyroid hormone improves healing of humerus after a fracture. The investigators will assess healing of the humerus with Constant score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Parathyroid hormone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1-84 parathyroid hormone | Drug | 100 micrograms of 1-84 parathyroid hormone daily for 8 weeks, subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in constant score | Constant score summarizes the function of the arm using a questionnaire (activities of daily living - ADL) and functional testing of the arm. | 5, 8, 11, 23, and 104 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Oxford Shoulder Score | Oxford shoulder score is a questionnaire that assesses the function of the arm through the evaluation of the participant. | 5, 8, 11, 23, and 104 weeks. |
| Changes in bone formation evaluated by X-ray. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars Hyldstrup, MDSc | Contact | hyld@dadlnet.dk | ||
| Ulrich C Bang, M.D. | Contact | ulrichbangbang@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre Hospital | Recruiting | Hvidovre | 2650 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19594305 | Background | Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, Garcia-Hernandez PA, Recknor CP, Einhorn TA, Dalsky GP, Mitlak BH, Fierlinger A, Lakshmanan MC. Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010 Feb;25(2):404-14. doi: 10.1359/jbmr.090731. | |
| 21915572 |
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| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| ID | Term |
|---|---|
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
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| Placebo | Drug | Saline injection daily for 8 weeks. |
|
| 5, 8, 11, 23, and 104 weeks. |
| Changes in biochemical bone markers | sodium, potassium, creatinine, liver enzymes, vitamin D, parathyroid hormone, alkaline phosphatase, hemoglobin, magnesium, calcium, zinc. | 0, 5, 25 weeks |
| Changes in regulatory T lymphocytes | Regulatory CD3+CD4+CD25+Foxp3+ T lymphocytes. | 0, 8, 24 weeks |
| Background |
| Peichl P, Holzer LA, Maier R, Holzer G. Parathyroid hormone 1-84 accelerates fracture-healing in pubic bones of elderly osteoporotic women. J Bone Joint Surg Am. 2011 Sep 7;93(17):1583-7. doi: 10.2106/JBJS.J.01379. |
| D000602 | Amino Acids, Peptides, and Proteins |