Ankle Fractures Treated With Teriparatide

Fracture, Ankle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02955056
• Other study ID #: 13OR006
• Secondary ID: 2015-005423-3214
• Status: Recruiting
• Phase: Phase 4
• First received: November 2, 2016
• Last updated: November 3, 2016
• Start date: October 2016
• Est. completion date: October 2017

Study information

• Verified date: November 2016
• Source: Nottingham University Hospitals NHS Trust
• Contact: Adel Alshaikh
• Email: msxla[@]nottingham.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Fractures
• Fracture, Ankle
• Fractures, Bone

Intervention

Drug:
• Forsteo
20 micrograms/80 microlitres solution for injection in pre-filled pen

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Functional assessment of the ankle using Olerud and Molander questionnaire	measure ankle function at the end of brace/cast treatment	Week 7 - Week 13	No