Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
10 participants
INTERVENTIONAL
2016-10-31
2017-10-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Teriparatide Intervention
Will be asked to self-administer Teriparatide treatment (self-injection) once a day for 12 weeks
Forsteo
20 micrograms/80 microlitres solution for injection in pre-filled pen
Usual care
No intervention, patients will be treated as per local practice but will be followed up identically to the intervention group.
No interventions assigned to this group
Interventions
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Forsteo
20 micrograms/80 microlitres solution for injection in pre-filled pen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Nottingham University Hospitals NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Angus Wallace
Role: STUDY_CHAIR
Nottingham University Hospitals NHS Trust
Locations
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Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2015-005423-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
143755
Identifier Type: OTHER
Identifier Source: secondary_id
13OR006
Identifier Type: -
Identifier Source: org_study_id