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The purpose of this study is to examine the effect of weekly dosing strategy on fracture healing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Injection product without active teriparatide |
|
| PTH 40ug/w | Experimental | Injection product with active teriparatide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant teriparatide for injection | Drug | weekly subcutaneous administration of 40 ug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The median time of radiographic healing | A score of 13 by Modified Radiographic Union Scale for Tibia fractures (mRUST) scoring system would provide a confident assessment of union | 0-14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Rated Wrist Evaluation | A 15-item questionnaire(PRWE) that rates wrist-related pain and disability in functional activities. The scores range from 0 (no disability) to 100 (severest disability). | 0, 4, 6, 8, 10, 12, 14 and 16 weeks |
| Grip strength |
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Inclusion Criteria:
Exclusion Criteria:
Postmenopausal women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junxiong Zhu, M.D. | Contact | +86 18801238160 | zhujunxiong@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chunli Song, M.D.; Ph. D. | Peking University Third Hospital | Principal Investigator |
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| 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. | |
| 28244906 |
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| ID | Term |
|---|---|
| D003100 | Colles' Fracture |
| ID | Term |
|---|---|
| D000072039 | Fracture Dislocation |
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Placebo | Drug | weekly subcutaneous administration of 40 ug |
|
|
Grip strength will be assessed by a dynamometer. |
| 6, 8, 10, 12, 14, and 16 weeks |
| Background |
| Ebata S, Takahashi J, Hasegawa T, Mukaiyama K, Isogai Y, Ohba T, Shibata Y, Ojima T, Yamagata Z, Matsuyama Y, Haro H. Role of Weekly Teriparatide Administration in Osseous Union Enhancement within Six Months After Posterior or Transforaminal Lumbar Interbody Fusion for Osteoporosis-Associated Lumbar Degenerative Disorders: A Multicenter, Prospective Randomized Study. J Bone Joint Surg Am. 2017 Mar 1;99(5):365-372. doi: 10.2106/JBJS.16.00230. |
| 28960481 | Background | Zhang W, Zhu J, Ma T, Liu C, Hai B, Du G, Wang H, Li N, Leng H, Xu Y, Song C. Comparison of the effects of once-weekly and once-daily rhPTH (1-34) injections on promoting fracture healing in rodents. J Orthop Res. 2018 Apr;36(4):1145-1152. doi: 10.1002/jor.23750. Epub 2017 Nov 20. |
| 33795297 | Derived | Zhu J, Zhang C, Jia J, Yuan W, Zhang M, Leng H, Song C. Effect of weekly teriparatide injections on osteoporotic fracture healing: protocol for a double-blind, randomised controlled trial. BMJ Open. 2021 Apr 1;11(4):e043137. doi: 10.1136/bmjopen-2020-043137. |
| D014947 |
| Wounds and Injuries |
| D011885 | Radius Fractures |
| D050723 | Fractures, Bone |