Study of Teriparatide in Stress Fracture Healing
RETURN
1 other identifier
interventional
136
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2019
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2019
CompletedFirst Posted
Study publicly available on registry
December 12, 2019
CompletedStudy Start
First participant enrolled
December 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedNovember 4, 2020
December 1, 2019
2.4 years
December 5, 2019
November 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Radiological healing.
Radiological healing by 2 Grades or more, or to grade zero at 8 weeks.
8 weeks.
Secondary Outcomes (7)
Radiological Healing
8, 10, 12, 14, 16, 20, 24 weeks
Time from randomisation to assessed as 'Clinically Healed'.
Twice weekly from date of radiologically healed stress fracture reported on MRI scan up to 24 weeks
Time to 'Healing' as a composite assessment.
Up to 24 weeks.
Time from randomisation to discharge from rehabilitation.
Up to 24 weeks
Pain symptoms on a visual analogue pain scale.
Diary to be completed weekly and analysed as a change from baseline to 16 weeks (24 weeks in an unhealed fracture).
- +2 more secondary outcomes
Other Outcomes (2)
P1NP response to teriparatide treatment.
Base line then 4 weekly to week 16 - extorted to week 24 in the case of an unhealed fracture.
CTX response to teriparatide treatment.
Base line then 4 weekly to week 16 - extorted to week 24 in the case of an unhealed fracture.
Study Arms (2)
Intervention - Teriparatide Treatment
EXPERIMENTALTeriparatide 20ug/day from confirmation of stress fracture for 16 weeks, with the potential to extend to 24 weeks if required.
Control - Standard Care
NO INTERVENTIONStandard rehabilitation care with additional monitoring to assess healing.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Signed informed consent form;
- Participant must be aged 18 - 40 years inclusive;
- Participant must have a lower limb stress fracture, either unilateral or bilateral, as confirmed via MRI scan;
- Undergoing phase 1 or 2 training within an Army training establishment;
- 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.
- Participants able to adhere to the visit schedule and protocol requirements.
You may not qualify if:
- Hypersensitivity to the active Parathyroid Hormone substance or any of the excipients listed in the SmPC.
- Pre-existing hypercalcaemia.
- Patients with skeletal malignancies or bone metastases.
- Any contraindications that would prevent the participant from undergoing an MRI scan.
- Concurrent therapy that, in the investigators opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
- 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.
- 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.
- Metabolic bone diseases including hyperparathyroidism and Paget's disease of the bone.
- Unexplained elevations of alkaline phosphatase.
- Prior external beam or implant radiation therapy to the skeleton.
- Patients participating in a concurrent drug trial.
- Presentation with open epiphyses during the diagnostic MRI scan.
- Participants with depression, as identified by completion of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Baseline.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Darlington Memorial Hospital
Darlington, County Durham, DL3 6HX, United Kingdom
Related Publications (1)
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.
PMID: 34461961DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Fraser, Dr
Norwich Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Blinded assessment of MR scans
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2019
First Posted
December 12, 2019
Study Start
December 23, 2019
Primary Completion
June 1, 2022
Study Completion
October 1, 2022
Last Updated
November 4, 2020
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share