A Phase 4 interventional study of Forsteo in Fracture, Ankle, sponsored by Nottingham University Hospitals NHS Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2016-11-04.
Sponsored by Nottingham University Hospitals NHS Trust · Phase 4, Interventional, and Treatment
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.
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.
196 studies on the registry are indexed under Ankle Fractures; 44 are open to participants now.
This study's planned enrollment of 10 is below the median of 92 across 149 interventional studies indexed under Ankle Fractures.
Browse Ankle Fractures studies →Nottingham University Hospitals NHS Trust is the lead sponsor of 107 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Will be asked to self-administer Teriparatide treatment (self-injection) once a day for 12 weeks
Drug: Forsteo
No intervention, patients will be treated as per local practice but will be followed up identically to the intervention group.
20 micrograms/80 microlitres solution for injection in pre-filled pen
Also known as: Teriparatide hormone
Assessment of healing parameters of the fracture
Assessment of healing parameters of the fracture as identified on the CT scan at Trial Visits
Time frame: Week 1 - Week 13
Identify the participant's pain during the treatment period
Pain scores on weight bearing, as assessed by 10-point visual analogue pain score scale
Time frame: Week 1 - Week 13
Functional assessment of the ankle using Olerud and Molander questionnaire
measure ankle function at the end of brace/cast treatment
Time frame: Week 7 - Week 13
Plan to share: No — No plan to share IPD
No publications or documents are linked to this record.
The record gives a start of Oct 2016, a primary completion of Oct 2017 and a completion of Oct 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Teriparatide
Nottingham University Hospitals NHS Trust →