Charcot osteoarthropathy MedDRA version: 17.0 Level: PT Classification code 10031173 Term: Osteoarthropathy System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Preotact
Product Name: Preotact
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Each dose of 71.4µl contains 100µg parathyr
Sponsors
King’s College Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient will be eligible for study participation if he or she meets the following criteria: 1. Aged 18 to 75 years inclusive 2. Has diabetes mellitus either Type 1 or Type 2 3. Has acute Charcot osteoarthropathy defined as recent onset of a unilateral hot swollen foot with foot skin temperature 2oC greater than the contralateral foot. Patients should either have bone fracture and joint subluxation on standard foot and ankle x-rays or bone marrow oedema and bone microfracture on MRI. 4. If female, is nonpregnant (negative pregnancy tests at the baseline visit) and nonlactating. 5. If female, is either not of childbearing potential (defined as postmenopausal for = 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or practising one of the following medically-acceptable methods of birth control and agrees to continue with the regimen throughout the duration of the study: a. Oral, implantable or injectable contraceptives for 3 consecutive months before the baseline visit. b. Total abstinence from sexual intercourse (= 1 complete menstrual cycle before the baseline visit). c. Intrauterine device d. Double barrier method (condoms, sponge, diaphragm or vaginal ring with spermicidal jellies or cream) 6. Meets the following laboratory criteria: a. Aspartate aminotransferase (AST) within 3x the upper limit of normal. b. Glycated Haemoglobin A1C (HbA1C) 30 ml/min and/or Creatinine clearance above 30 ml/min. 7. Must be able to fluently speak and understand English and be able to provide meaningful written informed consent for the study. 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 46 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46
Exclusion criteria
Exclusion criteria: A patient will be excluded from the study if he or she meets the following exclusion criteria: 1. Has active foot ulceration and infection 2. Patients taking drugs that may affect calcium metabolism, patients on immuno-suppression, inhaled corticosteroids, anabolic steroids , other treatment for osteoporosis, rheumatoid arthritis. 3. Patients with previous radiation therapy to skeleton, pre-existing hypercalcaemia, metabolic bone disease (including Paget’s and hyperparathyroidism) 4. Has any uncontrolled illness that, in the opinion of the Investigator, would interfere with interpreting the results of the study. 5. Has unexplained elevations of bone-specific alkaline phosphatase 6. Has severe renal impairment defined as eGFR< 30 ml/min 7. Has severe hepatic impairment defined as aspartate aminotransferase (AST) greater than 3x the upper limit of normal. 8. Has pre-existing hypercalcemia and other disturbances in the phosphocalcic metabolism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Can recombinant human parathyroid hormone (rh PTH 1-84) accelerate clinical resolution of the acute Charcot foot by enhancing bone repair and fracture healing. This will be asssessed in terms of: • Time to resolution of the acute Charcot foot • Percentage of patients with a clinical outcome of Charcot foot resolution by 6 months • Percentage of patients with a clinical outcome of Charcot foot resolution by 12 months ; Secondary Objective: Is there a difference in the percentage of patients that have achieved clinical resolution at 6 and 12 months between patients treated with rh-PTH compared with patients treated with standard treatment? Is there a difference in the percentage of patients with healed fractures on foot and ankle X-ray at clinical resolution between patients treated with rh-PTH compared with patients treated with standard treatment? Is there a difference in the percentage of patients with resolution of bone marrow oedema and bony union of fractures semi-quantitatively assessed on MRI at clinical resolution between patients treated with rh-PTH compared with patients treated with standard treatment? Is there a difference in the rate of change of bone turnover markers from baseline and up to clinical resolution of the Charcot foot between patients treated with rh-PTH compared with patients treated with standard treatment? Is there a difference in the rate of change of score in quality of life from ba ; Primary end point(s): The primary end point will be to determine whether there is a difference between active treatment with rh PTH 1-84 and standard treatment alone in terms of: - Time to resolution of the Charcot foot - Percentage of patients with a clinical outcome of Charcot foot resolution by 6 months. - Percentage of | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objectives will be to determine whether there is a difference between active treatment with rh PTH 1-84 and standard treatment alone in terms of: • Percentage of patients with healed fractures at clinical resolution on foot and ankle radiographs • Percentage of patients with bony union and healing of fractures at the time of clinical resolution on MRI scans • Rate of change of bone turnover markers from baseline and up to clinical resolution of the Charcot foot • Rate of change of score in quality of life from baseline up to clinical resolution using the SF-36 • Rate of change of score in quality of life from baseline and up to clinical resolution using the EQ-5D; ;Timepoint(s) of evaluation of this end point: At Clinical Resolution or at the end of the trial. | — |
Countries
United Kingdom
Contacts
Public ContactInvestigator's Trial Team
Kings College Hospital NHS Foundation Trust
Outcome results
None listed