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Ankle Fractures Treated With Teriparatide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02955056
Recruitment Status : Unknown
Verified November 2016 by Nottingham University Hospitals NHS Trust.
Recruitment status was:  Recruiting
First Posted : November 4, 2016
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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 Name: 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.



Primary Outcome Measures :
  1. Assessment of healing parameters of the fracture [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Week 7 - Week 13 ]
    measure ankle function at the end of brace/cast treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02955056


Contacts
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Contact: Adel Alshaikh msxla@nottingham.ac.uk
Contact: Maria Koufali researchsponsor@nuh.nhs.uk

Locations
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United Kingdom
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
Investigators
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Study Chair: Angus Wallace Nottingham University Hospitals NHS Trust

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Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02955056    
Other Study ID Numbers: 13OR006
2015-005423-32 ( EudraCT Number )
143755 ( Other Identifier: IRAS )
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD
Keywords provided by Nottingham University Hospitals NHS Trust:
Weber B
Additional relevant MeSH terms:
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Fractures, Bone
Ankle Fractures
Wounds and Injuries
Teriparatide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents