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Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture

Primary Purpose

Colles' Fracture

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
recombinant teriparatide for injection
Placebo
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colles' Fracture

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    PTH 40ug/w

    Arm Description

    Injection product without active teriparatide

    Injection product with active teriparatide

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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).
    Grip strength
    Grip strength will be assessed by a dynamometer.

    Full Information

    First Posted
    July 12, 2020
    Last Updated
    July 12, 2020
    Sponsor
    Peking University Third Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04473989
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2021 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University Third Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colles' Fracture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Injection product without active teriparatide
    Arm Title
    PTH 40ug/w
    Arm Type
    Experimental
    Arm Description
    Injection product with active teriparatide
    Intervention Type
    Drug
    Intervention Name(s)
    recombinant teriparatide for injection
    Other Intervention Name(s)
    Xinfutai
    Intervention Description
    weekly subcutaneous administration of 40 ug
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Xinfutai placebo
    Intervention Description
    weekly subcutaneous administration of 40 ug
    Primary Outcome Measure Information:
    Title
    The median time of radiographic healing
    Description
    A score of 13 by Modified Radiographic Union Scale for Tibia fractures (mRUST) scoring system would provide a confident assessment of union
    Time Frame
    0-14 weeks
    Secondary Outcome Measure Information:
    Title
    Patient-Rated Wrist Evaluation
    Description
    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).
    Time Frame
    0, 4, 6, 8, 10, 12, 14 and 16 weeks
    Title
    Grip strength
    Description
    Grip strength will be assessed by a dynamometer.
    Time Frame
    6, 8, 10, 12, 14, and 16 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Postmenopausal women
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Junxiong Zhu, M.D.
    Phone
    +86 18801238160
    Email
    zhujunxiong@bjmu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chunli Song, M.D.; Ph. D.
    Organizational Affiliation
    Peking University Third Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19594305
    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.
    Results Reference
    background
    PubMed Identifier
    28244906
    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.
    Results Reference
    background
    PubMed Identifier
    28960481
    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.
    Results Reference
    background
    PubMed Identifier
    33795297
    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.
    Results Reference
    derived

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    Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture

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