Clinical trial NCT04473989: Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture
Official title: The Effect of Weekly Injection of Teriparatide on the Healing of Distal Radius Fracture in a Double-blind, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colles' Fracture
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 80
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effect of weekly dosing strategy on fracture healing.


Eligibility criteria: Inclusion Criteria:

1. Postmenopausal women aged 45-75 (at least 2 years after menopause)
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:

1. Combine other physical diseases, including diabetes, severe hypertension, autoimmune diseases, heart, liver and kidney diseases, malignant tumors, mental illnesses, and other diseases that doctors believe may affect the healing process.
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.

Primary outcomes:
measure: The median time of radiographic healing
timeFrame: 0-14 weeks
Secondary outcomes:
measure: Patient-Rated Wrist Evaluation
timeFrame: 0, 4, 6, 8, 10, 12, 14 and 16 weeks
measure: Grip strength
timeFrame: 6, 8, 10, 12, 14, and 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Chunli Song, M.D.; Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.