Ankle Fractures Treated With Teriparatide

A Feasibility Study to Explore the Difference in Healing Time Between Teriparatide Treatment and Standard Care on Weber B Ankle Fractures in Older People

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.

Study Overview

• Status: Unknown
• Conditions: Fracture, Ankle
• Intervention / Treatment: Drug: Forsteo

Detailed Description

Ankle fractures are common in older people, they are very disabling and require either a cast or a boot for treatment and the patients need to use crutches for balance. These fractures can lead to complications including non union or delayed union in addition to risks of clotting of the leg vessels (deep vein thrombosis) where these clots can dislodge and migrate to the lungs (pulmonary embolus) resulting in breathing difficulties and/or death. Also these fractures commonly result in patients needing a temporary period of residential care. Therefore, if the healing time can be reduced, there is a potential for large benefits for the patient and reduced care costs for health and social care services.

Teriparatide hormone is one of the new medications used for treating osteoporosis(weak bones), and studies in the USA have reported that Teriparatide hormone treatment can accelerate bone fracture healing time in pelvic fractures.

Other reports also support faster healing time when Teriparatide hormone is used.

The investigators are carrying out this feasibility study with 10 participants, in order to provide the information that will prepare us for carrying out a definitive study in the future.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG7 2UH
    • Recruiting
    • Nottingham University Hospitals Nhs Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Teriparatide Intervention; Will be asked to self-administer Teriparatide treatment (self-injection) once a day for 12 weeks	Drug: Forsteo; 20 micrograms/80 microlitres solution for injection in pre-filled pen; Other Names: Teriparatide hormone
No Intervention: Usual care; No intervention, patients will be treated as per local practice but will be followed up identically to the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify the participant's pain during the treatment period	Pain scores on weight bearing, as assessed by 10-point visual analogue pain score scale	Week 1 - Week 13
Functional assessment of the ankle using Olerud and Molander questionnaire	measure ankle function at the end of brace/cast treatment	Week 7 - Week 13

Collaborators and Investigators

• Sponsor: Nottingham University Hospitals NHS Trust
• Investigators: Study Chair: Angus Wallace, Nottingham University Hospitals Nhs Trust

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: November 2, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimate): November 4, 2016

Study Record Updates

• Last Update Posted (Estimate): November 4, 2016
• Last Update Submitted That Met QC Criteria: November 3, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Weber B
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Ankle Fractures; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Teriparatide
• Other Study ID Numbers: 13OR006; 2015-005423-32 (EudraCT Number); 143755 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD