Study of Teriparatide in Stress Fracture Healing

Stress Fracture Clinical Trial

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Official title:

Study of Teriparatide in Stress Fracture Healing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04196855
• Other study ID #: 19/HRA/6011
• Status: Recruiting
• Phase: Phase 3
• Start date: December 23, 2019
• Est. completion date: October 2022

Study information

• Verified date: December 2019
• Source: University of East Anglia
• Contact: Katharine Law
• Phone: +44 (0)1603 591222
• Email: katharine.law[@]uea.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: October 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent form;

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:

1. Hypersensitivity to the active Parathyroid Hormone substance or any of the excipients listed in the SmPC.

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Stress
• Parathyroid Hormone
• Stress Fracture

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United Kingdom	Darlington Memorial Hospital	Darlington	County Durham

Sponsors (4)

Lead Sponsor	Collaborator
University of East Anglia	Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK), Darlington Memorial Hospital, Ministry of Defence, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	CTX 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.
Primary	Radiological healing.	Radiological healing by 2 Grades or more, or to grade zero at 8 weeks.	8 weeks.
Secondary	Radiological Healing	Time to complete radiological healing	8, 10, 12, 14, 16, 20, 24 weeks
Secondary	Time from randomisation to assessed as 'Clinically Healed'.	Physical assessment to commence once the fracture is reported as healed on MR.	Twice weekly from date of radiologically healed stress fracture reported on MRI scan up to 24 weeks
Secondary	Time to 'Healing' as a composite assessment.	Healing as assessed by MRI and clinical assessment.	Up to 24 weeks.
Secondary	Time from randomisation to discharge from rehabilitation.	Completion of rehab will be assessed using Army standard measures.	Up to 24 weeks
Secondary	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).
Secondary	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
Secondary	Adverse events	As reported in accordance with CTAE Version 4.03	Up to 28 weeks.