Ankle Fractures Treated With Teriparatide

• Sponsor: Nottingham University Hospitals NHS Trust (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02955056
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fracture, Ankle	Drug: Forsteo	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Oct 1, 2016
• Anticipated Primary Completion Date: Oct 1, 2017
• Anticipated Study Completion Date: Oct 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Assessment of healing parameters of the fracture [Week 1 - Week 13]

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

Secondary Outcome Measures

1. Identify the participant's pain during the treatment period [Week 1 - Week 13]

   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 [Week 7 - Week 13]

   measure ankle function at the end of brace/cast treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nottingham University Hospitals NHS Trust	Nottingham		United Kingdom	NG7 2UH

Sponsors and Collaborators

• Nottingham University Hospitals NHS Trust

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nottingham University Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT02955056
• Other Study ID Numbers: 13OR006; 2015-005423-32; 143755
• First Posted: Nov 4, 2016
• Last Update Posted: Nov 4, 2016
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Nottingham University Hospitals NHS Trust: Weber B
• Additional relevant MeSH terms: Fractures, Bone; Ankle Fractures; Teriparatide

Study Results

No Results Posted as of Nov 4, 2016