Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture
NCT ID: NCT04473989
Last Updated: 2020-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2021-06-01
2024-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Injection product without active teriparatide
Placebo
weekly subcutaneous administration of 40 ug
PTH 40ug/w
Injection product with active teriparatide
recombinant teriparatide for injection
weekly subcutaneous administration of 40 ug
Interventions
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recombinant teriparatide for injection
weekly subcutaneous administration of 40 ug
Placebo
weekly subcutaneous administration of 40 ug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. With primary osteoporosis
3. Patients with Colles fractures with a fracture time of no more than 7 days
4. conservative treatment after fracture (closed reduction and immobilization)
5. no multiple fractures
6. Informed well and agree to participate in this clinical trial
Exclusion Criteria
2. In addition to primary osteoporosis, any disease affecting bone metabolism or treatment response, including serum PTH\>65pg/ml, 25-hydroxyvitamin D\<20ng/ml, alkaline phosphatase\>135U/L, history of bone tumor, Paget disease, history of radiotherapy
3. The fracture site has a history of trauma or surgery, affecting the function of the wrist or forearm
4. Those who are allergic to PTH or any excipients
5. Currently receiving anti-osteoporosis treatment or receiving other anti-osteoporosis treatment during the trial
6. Contraindication of teriparatide including hyperparathyroidism, severe renal insufficiency, hypercalcemia, etc.
45 Years
75 Years
FEMALE
Yes
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Principal Investigators
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Chunli Song, M.D.; Ph. D.
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Central Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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M2020207
Identifier Type: -
Identifier Source: org_study_id
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