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Trial · Interventional

Status unknownPhase 2Registry data

Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture

NCTNCT04473989 (opens ClinicalTrials.gov in a new tab)Other idM2020207
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 2
Enrollment
80 participants (estimated)
Sponsor
Peking University Third Hospital · Other
Design
Randomized · Double masking
Countries
Not stated
Start
1 Jun 2021 (estimated)
Primary completion
1 Dec 2023 (estimated)
Completion
1 Jun 2024 (estimated)
First posted
16 Jul 2020
Last update posted
16 Jul 2020
Conditions
Colles' Fracture

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20212022202320242025
  1. Ph 2

    Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture

    NCT04473989

    est. 1 Jun 2021 to est. 1 Jun 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • recombinant teriparatide for injectionDrug
  • PlaceboDrug

Arms2

  • Placebo comparator

    Placebo

    Injection product without active teriparatide

  • Experimental

    PTH 40ug/w

    Injection product with active teriparatide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The median time of radiographic healing

    Time frame · 0-14 weeks

    Registry description

    A score of 13 by Modified Radiographic Union Scale for Tibia fractures (mRUST) scoring system would provide a confident assessment of union

Secondary outcomes(2)

  1. Patient-Rated Wrist Evaluation

    Time frame · 0, 4, 6, 8, 10, 12, 14 and 16 weeks

    Registry 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).

  2. Grip strength

    Time frame · 6, 8, 10, 12, 14, and 16 weeks

    Registry description

    Grip strength will be assessed by a dynamometer.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2017

2 results

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.

Ebata et al. 2017The Journal of bone and joint surgery. American volumecited by 120

PMID 28244906DOI 10.2106/jbjs.16.00230PUB-28244906

Full text at the publisher2 results
Publisher pageSee results (2)

Indexing hint: Randomized controlled trial · 2010

3 results

Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures.

Aspenberg et al. 2010Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 368

PMID 19594305DOI 10.1359/jbmr.090731PUB-19594305

Full text at the publisher3 results
Publisher pageSee results (3)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedZhu 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. PMID 33795297

Eligibility

Who could join, as posted.

Sex
Female
Age
from 45 Years up to 75 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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