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Trial · Interventional

Status unknownPhase 4Registry data

Ankle Fractures Treated With Teriparatide

NCTNCT02955056 (opens ClinicalTrials.gov in a new tab)Other id13OR006Other id2015-005423-32Other id143755Other id2015
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
10 participants (estimated)
Sponsor
Nottingham University Hospitals NHS Trust · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United Kingdom

Start
Oct 2016
Primary completion
Oct 2017 (estimated)
Completion
Oct 2017 (estimated)
First posted
4 Nov 2016 (estimated)
Last update posted
4 Nov 2016 (estimated)
Conditions
Fracture, Ankle

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 4

    Ankle Fractures Treated With Teriparatide

    NCT02955056

    Oct 2016 to est. Oct 2017

Registry summary

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

This is a single site feasibility trial to test whether daily administration of Teriparatide, in participants with Weber type B ankle fractures that are being conservatively managed, is superior to the standard care treatment with regard to the rate of healing.

Interventions

  • ForsteoDrug

Arms2

  • Experimental

    Teriparatide Intervention

    Will be asked to self-administer Teriparatide treatment (self-injection) once a day for 12 weeks

  • No intervention

    Usual care

    No intervention, patients will be treated as per local practice but will be followed up identically to the intervention group.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Assessment of healing parameters of the fracture

    Time frame · Week 1 - Week 13

    Registry description

    Assessment of healing parameters of the fracture as identified on the CT scan at Trial Visits

Secondary outcomes(2)

  1. Identify the participant's pain during the treatment period

    Time frame · Week 1 - Week 13

    Registry description

    Pain scores on weight bearing, as assessed by 10-point visual analogue pain score scale

  2. Functional assessment of the ankle using Olerud and Molander questionnaire

    Time frame · Week 7 - Week 13

    Registry description

    measure ankle function at the end of brace/cast treatment

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study. * Male or Female (women of non-child bearing potential only\*), aged 50 years or above * Ankle fracture Weber type B suitable for conservative treatment in a synthetic cast * The fracture should be less than 10 days old * Blood test results within the normal range as defined by Nottingham University Hospitals NHS Trust (FBC, ESR, LFT, RFT, PTH, Bone profile (Calcium, albumin, total protein and alkaline phosphatase) and thyroid function) * Able and willing to comply with all study requirements Exclusion Criteria: * Current smokers (both tobacco and electronic cigarettes) * Chronic renal disease * Insulin dependent diabetes mellitus * History of hypercalcemia * End stage liver disease (liver cirrhosis) * Patient with any current or past history of cancer * Use of bisphosphonates, Zolendronic acid or fluorides within the last 6 months * Any bone conditions other than osteoporosis * Unable to get out of a chair or bed and walk without the help of another person pre ankle fracture (walking aids are acceptable) * Contraindication to Teriparatide hormone: * Hypersensitivity * High risk of Osteosarcoma, (Paget's disease, chondromas, exposure to radiation, unexplained alkaline phosphatase, etc.) * Female participants of child-bearing potential, who are pregnant, lactating or planning pregnancy during course of study * Scheduled elective surgery or other procedures requiring general anaesthesia during the study * Terminally ill * Planned blood donor donation during the study * Participated in another research study involving an investigational product in the past 12 weeks * Prior external beam of radiation or implant of radiation therapy to the skeleton. * Any blood diseases leading to a bleeding tendency * On Heparin, Warfarin or any Anticoagulants

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