NCT02955056

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

November 2, 2016

Last Update Submit

November 3, 2016

Conditions

Fracture, Ankle

Keywords

Weber B

Outcome Measures

Primary Outcomes (1)

  • Assessment of healing parameters of the fracture

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

    Week 1 - Week 13

Secondary Outcomes (2)

  • Identify the participant's pain during the treatment period

    Week 1 - Week 13

  • Functional assessment of the ankle using Olerud and Molander questionnaire

    Week 7 - Week 13

Study Arms (2)

Teriparatide Intervention

EXPERIMENTAL

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

Drug: Forsteo

Usual care

NO INTERVENTION

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

Interventions

ForsteoDRUG

20 micrograms/80 microlitres solution for injection in pre-filled pen

Also known as: Teriparatide hormone
Teriparatide Intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Ankle Fractures

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Angus Wallace

    Nottingham University Hospitals NHS Trust

    STUDY CHAIR

Central Study Contacts

Adel Alshaikh

CONTACT

msxla@nottingham.ac.uk

Maria Koufali

CONTACT

researchsponsor@nuh.nhs.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 4, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

November 4, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

No plan to share IPD

Locations

GB(1)