Study of Teriparatide in Stress Fracture Healing: RETUR

Phase 1

• Conditions: Healthy individuals with stress fractures.; MedDRA version: 20.1Level: PTClassification code 10042212Term: Stress fractureSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2018-002130-20-GB
• Lead Sponsor: orfolk and Norwich University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-19
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

1)Signed informed consent and able to comply with protocol;
2)Aged 18 to 40 years;
3)Lower limb stress fracture, confirmed by MRI scan;
4)Undergoing phase 1 or 2 training within an Army training establishment;
5)Baseline blood tests within reference range (see table 3 for more details). Minor abnormalities will be assessed by the PI. Patients will still be eligible if these are felt to be of no clinical importance and this decision is documented by the PI;
6)Participant is able to adhere to visit requirements.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 136
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1)Hypersensitivity to the active Parathyroid Hormone substance or any of the excipients listed in the SPC.
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 birth control method which may be considered as highly effective”, 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.

**As per the CTFG guidance and for the purposes of this trial, a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12-months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.

In accordance with CTFG guidance, methods that can achieve a failure rate of less than 1% per year when used consistently and correctly, are considered as highly effective” birth control methods. Such methods include:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (either oral, intravaginal or transdermal);
- Progestogen-only hormonal contraception associated with inhibition of ovulation (either oral, injectable or implantable);
- Intrauterine device (IUD);
- Intrauterine hormone-releasing system (IUS);
- Bilateral tubal occlusion;
- Vasectomised partner;
- Sexual abstinence. (Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated for the duration of the participant’s treatment period during the trial and the preferred and usual lifestyle of the participant.)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified