Ankle Fractures Treated With Teriparatide

• Status: Unknown status
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nottingham University Hospitals NHS Trust
• Treatments: Teriparatide

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