Ankle Fractures Treated With Teriparatide
Primary Purpose
Fracture, Ankle
Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Forsteo
Sponsored by
About this trial
This is an interventional treatment trial for Fracture, Ankle focused on measuring Weber B
Eligibility 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
Sites / Locations
- Nottingham University Hospitals NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Teriparatide Intervention
Usual care
Arm Description
Will be asked to self-administer Teriparatide treatment (self-injection) once a day for 12 weeks
No intervention, patients will be treated as per local practice but will be followed up identically to the intervention group.
Outcomes
Primary Outcome Measures
Assessment of healing parameters of the fracture
Assessment of healing parameters of the fracture as identified on the CT scan at Trial Visits
Secondary Outcome Measures
Identify the participant's pain during the treatment period
Pain scores on weight bearing, as assessed by 10-point visual analogue pain score scale
Functional assessment of the ankle using Olerud and Molander questionnaire
measure ankle function at the end of brace/cast treatment
Full Information
NCT ID
NCT02955056
First Posted
November 2, 2016
Last Updated
November 3, 2016
Sponsor
Nottingham University Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02955056
Brief Title
Ankle Fractures Treated With Teriparatide
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nottingham University Hospitals NHS Trust
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture, Ankle
Keywords
Weber B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Teriparatide Intervention
Arm Type
Experimental
Arm Description
Will be asked to self-administer Teriparatide treatment (self-injection) once a day for 12 weeks
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
No intervention, patients will be treated as per local practice but will be followed up identically to the intervention group.
Intervention Type
Drug
Intervention Name(s)
Forsteo
Other Intervention Name(s)
Teriparatide hormone
Intervention Description
20 micrograms/80 microlitres solution for injection in pre-filled pen
Primary Outcome Measure Information:
Title
Assessment of healing parameters of the fracture
Description
Assessment of healing parameters of the fracture as identified on the CT scan at Trial Visits
Time Frame
Week 1 - Week 13
Secondary Outcome Measure Information:
Title
Identify the participant's pain during the treatment period
Description
Pain scores on weight bearing, as assessed by 10-point visual analogue pain score scale
Time Frame
Week 1 - Week 13
Title
Functional assessment of the ankle using Olerud and Molander questionnaire
Description
measure ankle function at the end of brace/cast treatment
Time Frame
Week 7 - Week 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adel Alshaikh
Email
msxla@nottingham.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Koufali
Email
researchsponsor@nuh.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angus Wallace
Organizational Affiliation
Nottingham University Hospitals NHS Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD
Learn more about this trial
Ankle Fractures Treated With Teriparatide
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