EUCTR2010-020973-18-PL进行中（未招募）不适用
Effect of treatment with ossein-hydroxyapatite compound on the time of fracture-healing”. A prospective, multicenter, double-blind, randomised, placebo controlled clinical trial.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- 性别
- All
入选标准
- •To be included in the trial, patients should fulfill the following criteria:
- •- male or menopausal female between 50 and 80 years of age,
- •- a recent closed Colles’ fracture (< 48 hours ), correctly reduced and stabilised with Kirschner wires,
- •- willing, able to understand and sign an approved Informed Consent Form,
- •- able to understand the protocol and to come to the control visits,
- •- registered with a social security or health insurance system (if applicable).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
排除标准
- •Patients fulfilling at least one of the following criteria cannot be included in the study:
- •- a criterion connected to pathologies:
- •- Patient with an open fracture,
- •- Patient with a bilateral Colles’ fracture or multiple concurrent fractures or injuries,
- •- Patient with fracture which may require a surgical treatment during the study treatment,
- •- Patient having had a fracture of the upper limb or a prolonged immobilization during the 12 months preceding the inclusion,
- •- Patient having had a functional impairment of the hand or the forearm before injury,
- •- Patient with a pathological fractures related to cancer,
- •- Patient with hereditary bone disease,
- •- Patient with bone necrosis,
- •- Patient with chronic renal failure or chronic kidney disease or history of renal calculi,
- •- Patient with history of calcium metabolism disorders (hypercalcemia, hypocalcemia…),
- •- a criterion connected to previous or concomitant treatment:
- •- Patient receiving or have received treatment by chemotherapy, radiotherapy, immunosuppressive or systemic steroid treatment within 6 months prior to the inclusion visit,
- •- Patient receiving or expected to receive during the course of the study any medication (other than study medication) which might alter bone metabolism: Calcium and phosphate preparations, calcitonin, hormone replacement therapy, anabolic agents, parathormone, heparins (long term treatment), barbiturates, hydantoin, insulin, thiazides,
- •- Patient with a known allergy to the study medication or one of its constituents,
- •- Patient requiring regular or intermittent steroid therapy.
- •- a criterion connected to the study population:
- •- Patient with a body mass index (BMI) greater than 34,
- •- Patient with generalized rheumatic disease (rheumatoid arthritis, osteoarthritis…) which could impair severely the joint function of the upper limbs,
- •- Patient with concomitant disease known to delay the time of frature-healing such as diabetes, respiratory insufficiency, anaemia, vascular insufficiency, thrombophlebitis….
- •- Patient with an inflammatory bowel disease or any digestive disease which could modify calcium absorption,
- •- Patient with known history of lactose intolerance, hereditary galactose intolerance, the Lapp lactase deficiency or glucose / galactose malabsorption
- •- Patient with a severe acute or chronic disease which the investigator deems incompatible with study implementation,
- •- Patient with a disease which the investigator considers likely to interfere with the study results or to expose the patient to additional risk,
- •- Patient liable not to comply with protocol instructions and/or with treatment, in the investigator's opinion,
- •- Patient having taken part in a clinical trial in the preceding 30 days or taking part in a trial at the time of inclusion,
- •- Patient linguistically or psychologically unable to understand and sign the consent form,
- •- Patient who has forfeited his freedom by administrative or legal award, or who is under guardianship.
研究者
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