Fracture, AnklePhase 4NCT02955056
Ankle Fractures Treated With Teriparatide
A Phase 4 study testing Forsteo in people with Fracture, Ankle, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Fracture, Ankle
- What is being tested?
- Forsteo
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2016to Oct 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Adel Alshaikh contact
Maria Koufali contact
United Kingdom1 site, 1 recruiting
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
About this study
Official title: A Feasibility Study to Explore the Difference in Healing Time Between Teriparatide Treatment and Standard Care on Weber B Ankle Fractures in Older People
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.
Read the detailed 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.
- Conditions
- Fracture, Ankle
- Being tested
- Forsteo
- Keywords
- Weber B
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ForsteoDrug
Also called Teriparatide hormone
20 micrograms/80 microlitres solution for injection in pre-filled pen
| Study group | Role | What they receive |
|---|---|---|
| Teriparatide Intervention | Experimental | Will be asked to self-administer Teriparatide treatment (self-injection) once a day for 12 weeks Receives: Drug: Forsteo |
| Usual care | No intervention | No intervention, patients will be treated as per local practice but will be followed up identically to the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of healing parameters of the fracture
Assessment of healing parameters of the fracture as identified on the CT scan at Trial Visits
Measured: Week 1 - Week 13
Secondary outcomes (2)
Identify the participant's pain during the treatment period
Pain scores on weight bearing, as assessed by 10-point visual analogue pain score scale
Measured: Week 1 - Week 13
Functional assessment of the ankle using Olerud and Molander questionnaire
measure ankle function at the end of brace/cast treatment
Measured: Week 7 - Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture, AnkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angus Wallace, Study chair, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955056
- Sponsor's protocol ID
- 13OR006
- Other IDs
- 2015-005423-32, 143755, 2015
- Status last verified
- Nov 2016
- First submitted
- 2 Nov 2016
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Explore the Difference in Healing Time Between Teriparatide Treatment and Standard Care on Weber B Ankle Fractures in Older People
- ClinicalTrials.gov ID
- NCT02955056
- Acronym / sponsor ID
- 13OR006
- Conditions
- Fracture, Ankle
- Keywords
- Weber B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teriparatide Intervention | Experimental | Drug: ForsteoWill 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (20 listed)
- Current smokers (both tobacco and electronic cigarettes)
- Chronic renal disease
- Insulin dependent diabetes mellitus
- History of hypercalcemia
- End stage liver disease (liver cirrhosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ForsteoAlso: Teriparatide hormone20 micrograms/80 microlitres solution for injection in pre-filled pen | Drug | Teriparatide Intervention |
Primary outcome
Assessment of healing parameters of the fracture
Time frame: Week 1 - Week 13
Assessment of healing parameters of the fracture as identified on the CT scan at Trial Visits
2 secondary outcomes
Identify the participant's pain during the treatment period
Time frame: Week 1 - Week 13
Functional assessment of the ankle using Olerud and Molander questionnaire
Time frame: Week 7 - Week 13
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Individual participant dataSharing planned: No. No plan to share IPD
Related trials for Fracture, Ankle
Recruiting
Investigating Auto Adjusting Dynamic AFO
Lower Limb; Fusion, Congenital, Lower Limb Fracture
Recruiting
Lateral Ankle Treatment
Avulsion Fracture
RecruitingObservational study
Use of Bioresorbable Magnesium Set Screws in Syndesmotic Injuries: a Pilot Study
Syndesmotic Injury, Trimalleolar Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
Recruiting
Hardware Removal After ORIF of Ankle Fractures
Ankle Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adel Alshaikh contact
Maria Koufali contact
Angus Wallace study chair
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Forsteo in people with Fracture, Ankle, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adel Alshaikh (msxla@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of healing parameters of the fracture (time frame: Week 1 - Week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2016.