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
PHASE3
136 participants
INTERVENTIONAL
2019-12-23
2022-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention - Teriparatide Treatment
Teriparatide 20ug/day from confirmation of stress fracture for 16 weeks, with the potential to extend to 24 weeks if required.
Teriparatide
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.
Control - Standard Care
Standard rehabilitation care with additional monitoring to assess healing.
No interventions assigned to this group
Interventions
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Teriparatide
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant must be aged 18 - 40 years inclusive;
3. Participant must have a lower limb stress fracture, either unilateral or bilateral, as confirmed via MRI scan;
4. Undergoing phase 1 or 2 training within an Army training establishment;
5. Blood Tests within reference range. Minor abnormalities will be assessed by the PI. Patients will still be entered if these are felt to be of no clinical importance.
6. Participants able to adhere to the visit schedule and protocol requirements.
Exclusion Criteria
2. Pre-existing hypercalcaemia.
3. Patients with skeletal malignancies or bone metastases.
4. Any contraindications that would prevent the participant from undergoing an MRI scan.
5. Concurrent therapy that, in the investigators opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
6. Pregnancy, suspected pregnancy or breastfeeding. Female participants must have a negative serum pregnancy test at screening and be willing and able to use a "highly effective" method of contraception, as per the Clinical Trial Facilitation Group (CTFG) guidance.
7. Severe renal impairment. Participants with moderate renal impairment will be treated with caution at the Principal Investigator's discretion and in accordance with the SmPC.
8. Metabolic bone diseases including hyperparathyroidism and Paget's disease of the bone.
9. Unexplained elevations of alkaline phosphatase.
10. Prior external beam or implant radiation therapy to the skeleton.
11. Patients participating in a concurrent drug trial.
12. Presentation with open epiphyses during the diagnostic MRI scan.
13. Participants with depression, as identified by completion of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Baseline.
18 Years
40 Years
ALL
No
Sponsors
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Ministry of Defence, United Kingdom
OTHER_GOV
Darlington Memorial Hospital
UNKNOWN
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
OTHER
University of East Anglia
OTHER
Responsible Party
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Principal Investigators
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William Fraser, Dr
Role: PRINCIPAL_INVESTIGATOR
Norwich Medical School
Locations
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Darlington Memorial Hospital
Darlington, County Durham, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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David Rollins
Role: primary
References
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Carswell AT, Eastman KG, Casey A, Hammond M, Shepstone L, Payerne E, Toms AP, MacKay JW, Swart AM, Greeves JP, Fraser WD. Teriparatide and stress fracture healing in young adults (RETURN - Research on Efficacy of Teriparatide Use in the Return of recruits to Normal duty): study protocol for a randomised controlled trial. Trials. 2021 Aug 30;22(1):580. doi: 10.1186/s13063-021-05556-3.
Other Identifiers
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19/HRA/6011
Identifier Type: -
Identifier Source: org_study_id