Ankle Fractures Treated With Teriparatide
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|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
|Condition or disease||Intervention/treatment||Phase|
|Fracture, Ankle||Drug: Forsteo||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Teriparatide Intervention
Will be asked to self-administer Teriparatide treatment (self-injection) once a day for 12 weeks
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.
- 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
- 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
- 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
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
|Contact: Adel Alshaikhemail@example.com|
|Contact: Maria Koufalifirstname.lastname@example.org|
|Nottingham University Hospitals NHS Trust||Recruiting|
|Nottingham, United Kingdom, NG7 2UH|
|Study Chair:||Angus Wallace||Nottingham University Hospitals NHS Trust|