Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture

Colles' Fracture Clinical Trial

Official title:

The Effect of Weekly Injection of Teriparatide on the Healing of Distal Radius Fracture in a Double-blind, Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04473989
• Other study ID #: M2020207
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2020
• Source: Peking University Third Hospital
• Contact: Junxiong Zhu, M.D.
• Phone: +86 18801238160
• Email: zhujunxiong[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colles' Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Drug:
• recombinant teriparatide for injection
weekly subcutaneous administration of 40 ug
• Placebo
weekly subcutaneous administration of 40 ug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

References & Publications (3)

Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, García-Hernández 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Grip strength	Grip strength will be assessed by a dynamometer.	6, 8, 10, 12, 14, and 16 weeks