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| Name | Class |
|---|---|
| Ministry of Defence, United Kingdom | OTHER_GOV |
| Darlington Memorial Hospital | UNKNOWN |
| Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - Teriparatide Treatment | Experimental | Teriparatide 20ug/day from confirmation of stress fracture for 16 weeks, with the potential to extend to 24 weeks if required. |
|
| Control - Standard Care | No Intervention | Standard rehabilitation care with additional monitoring to assess healing. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological healing. | Radiological healing by 2 Grades or more, or to grade zero at 8 weeks. | 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological Healing | Time to complete radiological healing | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| P1NP response to teriparatide treatment. | Measurement of bone marker of formation. | Base line then 4 weekly to week 16 - extorted to week 24 in the case of an unhealed fracture. |
| CTX response to teriparatide treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katharine Law | Contact | +44 (0)1603 591222 | katharine.law@uea.ac.uk | |
| Alexander Carswell, Dr | Contact | a.carswell@uea.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| William Fraser, Dr | Norwich Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Darlington Memorial Hospital | Recruiting | Darlington | County Durham | DL3 6HX | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34461961 | Derived | 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. |
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| ID | Term |
|---|---|
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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Blinded assessment of MR scans
|
|
| 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. | Up to 24 weeks. |
| Time from randomisation to discharge from rehabilitation. | Completion of rehab will be assessed using Army standard measures. | 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. | 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. | 4 weekly from baseline to 16 weeks |
| Adverse events | As reported in accordance with CTAE Version 4.03 | Up to 28 weeks. |
Measurement of bone marker of formation.
| Base line then 4 weekly to week 16 - extorted to week 24 in the case of an unhealed fracture. |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |