- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04473989
Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture
July 12, 2020 updated by: Peking University Third Hospital
The Effect of Weekly Injection of Teriparatide on the Healing of Distal Radius Fracture in a Double-blind, Randomized Controlled Clinical Trial
The purpose of this study is to examine the effect of weekly dosing strategy on fracture healing.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Junxiong Zhu, M.D.
- Phone Number: +86 18801238160
- Email: zhujunxiong@bjmu.edu.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Postmenopausal women aged 45-75 (at least 2 years after menopause)
- With primary osteoporosis
- Patients with Colles fractures with a fracture time of no more than 7 days
- conservative treatment after fracture (closed reduction and immobilization)
- no multiple fractures
- Informed well and agree to participate in this clinical trial
Exclusion Criteria:
- 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.
- 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
- The fracture site has a history of trauma or surgery, affecting the function of the wrist or forearm
- Those who are allergic to PTH or any excipients
- Currently receiving anti-osteoporosis treatment or receiving other anti-osteoporosis treatment during the trial
- Contraindication of teriparatide including hyperparathyroidism, severe renal insufficiency, hypercalcemia, etc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
Injection product without active teriparatide
|
weekly subcutaneous administration of 40 ug
Other Names:
|
EXPERIMENTAL: PTH 40ug/w
Injection product with active teriparatide
|
weekly subcutaneous administration of 40 ug
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The median time of radiographic healing
Time Frame: 0-14 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-Rated Wrist Evaluation
Time Frame: 0, 4, 6, 8, 10, 12, 14 and 16 weeks
|
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
Time Frame: 6, 8, 10, 12, 14, and 16 weeks
|
Grip strength will be assessed by a dynamometer.
|
6, 8, 10, 12, 14, and 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
June 1, 2021
Primary Completion (ANTICIPATED)
December 1, 2023
Study Completion (ANTICIPATED)
June 1, 2024
Study Registration Dates
First Submitted
July 12, 2020
First Submitted That Met QC Criteria
July 12, 2020
First Posted (ACTUAL)
July 16, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 16, 2020
Last Update Submitted That Met QC Criteria
July 12, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2020207
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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