Investigation into the use of teriparatide in the treatment of stress fractures. Primary outcome is healing on MRI, secondary outcomes are pain, time spent in rehabilitation and future stress fractures. This study will help the investigators understand how to treat stress fractures in the future.
Teriparatide is a drug that is designed to have a similar effect on the body as parathyroid hormone. Parathyroid hormone is made naturally in the body and is released in response to low calcium levels. It helps to maintain bone health and repair bone damage. Parathyroid hormone and medicines like teriparatide can strengthen bones and are often given to people with osteoporosis (a condition that weakens bones, making them more likely to break) to reduce the risk of fractures. Recent studies have also shown benefits in people with stress fracture injuries, a form of bone damage sometimes caused by repetitive exercise. The investigators want to know if teriparatide is also beneficial to healthy, younger people who have a stress fracture injury.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
136
Terrosa 20 micrograms/80 microliters solution for injection. Each dose of 80 microliters contains 20 micrograms of teriparatide. One cartridge of 2.4 mL of solution contains 600 micrograms of teriparatide (corresponding to 250 micrograms per mL). Teriparatide, rhPTH(1-34), produced in E. coli, using recombinant DNA technology, is identical to the 34-N-terminal amino acid sequence of endogenous human parathyroid hormone.
Darlington Memorial Hospital
Darlington, County Durham, United Kingdom
RECRUITINGRadiological healing.
Radiological healing by 2 Grades or more, or to grade zero at 8 weeks.
Time frame: 8 weeks.
Radiological Healing
Time to complete radiological healing
Time frame: 8, 10, 12, 14, 16, 20, 24 weeks
Time from randomisation to assessed as 'Clinically Healed'.
Physical assessment to commence once the fracture is reported as healed on MR.
Time frame: Twice weekly from date of radiologically healed stress fracture reported on MRI scan up to 24 weeks
Time to 'Healing' as a composite assessment.
Healing as assessed by MRI and clinical assessment.
Time frame: Up to 24 weeks.
Time from randomisation to discharge from rehabilitation.
Completion of rehab will be assessed using Army standard measures.
Time frame: Up to 24 weeks
Pain symptoms on a visual analogue pain scale.
Score between 0 and 10 - with 0 being no pain and 10 being worst pain imaginable.
Time frame: Diary to be completed weekly and analysed as a change from baseline to 16 weeks (24 weeks in an unhealed fracture).
Difference in Quality of life
Assessed by Short Form 36 Questionnaire. The higher score, the better the participants quality of life.
Time frame: 4 weekly from baseline to 16 weeks
Adverse events
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As reported in accordance with CTAE Version 4.03
Time frame: Up to 28 weeks.