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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005423-32 | EudraCT Number | ||
| 143755 | Other Identifier | IRAS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teriparatide Intervention | Experimental | Will be asked to self-administer Teriparatide treatment (self-injection) once a day for 12 weeks |
|
| Usual care | No Intervention | No intervention, patients will be treated as per local practice but will be followed up identically to the intervention group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forsteo | Drug | 20 micrograms/80 microlitres solution for injection in pre-filled pen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of healing parameters of the fracture | Assessment of healing parameters of the fracture as identified on the CT scan at Trial Visits | Week 1 - Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Identify the participant's pain during the treatment period | Pain scores on weight bearing, as assessed by 10-point visual analogue pain score scale | Week 1 - Week 13 |
| Functional assessment of the ankle using Olerud and Molander questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adel Alshaikh | Contact | msxla@nottingham.ac.uk | ||
| Maria Koufali | Contact | researchsponsor@nuh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Angus Wallace | Nottingham University Hospitals NHS Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham University Hospitals NHS Trust | Recruiting | Nottingham | NG7 2UH | United Kingdom |
No plan to share IPD
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| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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measure ankle function at the end of brace/cast treatment
| Week 7 - Week 13 |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |