Ankle Fractures Treated With Teriparatide

NHS Trust

Status and phase

Unknown

Phase 4

Conditions

Fracture, Ankle

Treatments

Drug: Forsteo

Study type

Interventional

Funder types

Other

Identifiers

NCT02955056

143755 (Other Identifier)

13OR006

2015-005423-32 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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