Teriparatide for Fracture Repair in Humans: A Prospective, Randomized, Double-blind Placebo-controlled Pilot Study in Female and Male Patients With Proximal Humerus Fracture: The TERAFRAP Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Identification of bone and callus patterns in the CT data at the fracture site
研究概览
简要总结
This study will test the hypothesis that daily subcuaneous administration of 20µg of teriparatide (TPTD) as compared to daily subcuaneous placebo for twelve weeks accelerates proximal 2-segment humerus fracture healing and improves the three dimensional structural properties of bone as measured via quantitative bone image analysis and finite element modeling assessed by quantitative computed tomography.
详细描述
- Primary objective:
The primary objective is the quantitative assessment of fracture healing (2-segment proximal humerus frafcture) in the treatment (daily teriapratide 20µg subcitaneous injection for 12 weeks) and in the placebo group (daily placebo subcutaneous injection for 12 weeks) based on computed tomography data (QCT; baseline and after 12 weeks) and computational analysis of the three simensional bone structure in the fracture zone. Bone structure will be assessed by means of quantized bone texture characteristics (callus formation, improvement of trabecualar and cortical bone structure) in the vicinity of the fracture. 2. Secondary objectives:
2.1.Detection and quantification of changes in bone mineralization at the fracture site between a baseline QCT scan and a follow-up QCT scan (planned interval: 12 weeks) using 3-D texture-based cluster analysis between the two groups.
2.2 Evaluation of bone strength variation in the proximal humerus and the measurement of biomechanical properties (stiffness, strength, damage) based on the Finite Element (FE) technique between the two groups.
2.3.Baseline characterization of osteoporotic study population: age, sex, concomitant diseases, serum markers of bone formation and bone resorption, serum colecalciferol levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •recent proximal 2-segment humerus fracture (0-8 days post fracture)
- •no surgical treatment at fractured site
- •signed informed consent
- •postmenopausal female and male patients aged 60 - 85 years
- •established osteoporosis as defined by BMD measured with DXA-technology (dual energy X-ray absorptiometry) with a T-score ≤ -2.0 spine or hip
排除标准
- •Hypersensitivity to the active substance or to any of the excipients.
- •Pre-existing hypercalcemia
- •Severe renal impairment (eGFR< 35ml/min)
- •Metabolic bone diseases (including hyperparathyroidism and Paget's disease of the bone) other than primary osteoporosis or glucorticoid-induced osteoporosis.
- •Unexplained elevations of alkaline phosphatase
- •Prior external beam or implant radiation therapy to the skeleton
- •Patients with skeletal malignancies or bone metastases should be excluded from treatment with teriparatide.
- •any prior antiresorptive therapy (oral/intravenous bisphosphonates, RANKL-antibody, SERMs)
- •any prior strontium ranelate therapy
- •any prior TPTD of PTH 1-84 therapy
- •malignancies ≤ 5 years except basalioma
- •hypo-/hypercalcemia
- •baseline 25-OH vitamin D3 level ≤10 ng/ml
- •prosthesis at fractured and contralateral humerus
研究组 & 干预措施
Teriparatide
Teriparatide 20µg daily subcutaneous injection for 12 weeks after proximal humerus fracture
干预措施: Teriparatide (Drug)
Placebo-Teriparatide
Placebo-Teriparatide 20 µg daily subcutaneous injection for 12 weeks after proximal humerus fracture
干预措施: Placebo (Drug)
结局指标
主要结局
Identification of bone and callus patterns in the CT data at the fracture site
时间窗: 12 weeks
As a basis for change quantification, we will identify 3D micro-architecture patterns that occur in the study CT data. These patterns are either learned based on annotated examples, manual segmentation of specific regions in a number of reference examples, or in a data-driven fashion (computer based identification of pattern classes).
次要结局
- Finite Element Analysis (FEA) of QCT (quantitative computed tomography) data(12 weeks)
研究者
Dr. Christian Muschitz
Senior Consultant for Internal Medicine
Medical University of Vienna