UnknownPhase 4

Ankle Fractures Treated With Teriparatide

United Kingdom10 participantsStarted 2016-10

Plain-language 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.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 requirin…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of healing parameters of the fracture

Timeframe: Week 1 - Week 13

Trial details

NCT IDNCT02955056

SponsorNottingham University Hospitals NHS Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10

Contact for this trial

Adel Alshaikh

msxla@nottingham.ac.uk

View on ClinicalTrials.gov More Fracture, Ankle trials

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.