EUCTR2009-016873-13-GB进行中（未招募）1 期
A novel therapy using recombinant human PTH 1-84 to stimulate bone repair and enhance fracture healing in the acute Charcot foot: a double blind placebo controlled phase IV trial - A novel therapy using human PTH 1-84 in the acute Charcot foot
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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) < 12%
- •c.Patients with eGFR> 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
排除标准
- •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.
研究者
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