Teriparatide for fracture repair in humans: A prospective, randomized, double-blind placebo-controlled pilot study in female and male patients with proximal humerus fractureThe TERAFRAP Study - TERAFRAP

Vinforce - Institut für Osteoporoseforschung0 个研究点开始时间: 2014年9月11日最近更新: 2014年11月10日

试验速览

暂无简介。

•recent proximal 2-segment humerus fracture (0-8 days post fracture)
•no surgical treatment at fractured site
•informed consent
•postmenopausal female and male patients aged 60 – 85 years
•established osteoporosis as defined by BMD measured with DXA-technology with a T-score = -2.0 spine or hip
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 75

•any contraindication against teriparatide (TPTD, rhPTH 1-34)
•oHypersensitivity to the active substance or to any of the excipients.
•oPre-existing hypercalcemia
•oSevere renal impairment (eGFR< 35ml/min)
•oMetabolic bone diseases (including hyperparathyroidism and Paget’s disease of the bone) other than primary osteoporosis or glucorticoid-induced osteoporosis.
•oUnexplained elevations of alkaline phosphatase
•oPrior external beam or implant radiation therapy to the skeleton
•oPatients 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

发起方

Vinforce - Institut für Osteoporoseforschung