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

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:

  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.

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
Drug: Placebo
weekly subcutaneous administration of 40 ug
Other Names:
  • Xinfutai placebo
EXPERIMENTAL: PTH 40ug/w
Injection product with active teriparatide
Drug: recombinant teriparatide for injection
weekly subcutaneous administration of 40 ug
Other Names:
  • Xinfutai

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

Peking University Third Hospital

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

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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