2025-521301-40-00招募中4 期
Prospective, randomized, multicentre study to compare the efficacy at 52 weeks (1 year) of biosimilar teriparatide and alendronate in the prevention of new morphometric vertebral fractures and/or worsening of previous vertebral fractures in women with a clinical vertebral fracture or recent hip fracture (imminent risk of fracture) caused by bone fragility.
Gedeon Richter Iberica S.A.20 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2025年2月26日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 127
- 试验地点
- 20
- 主要终点
- The main evaluation criterion will be the percentage of patients with at least one new morphometric vertebral fracture (incident vertebral fractures) or the increase in severity of a known vertebral fracture (vertebral re-fracture) during the 52-week study period. For the diagnosis and grading of vertebral fractures, the Genant semi-quantitative method will be used on thoracic and lumbar radiographs.
研究概览
简要总结
To evaluate the efficacy of biosimilar teriparatide compared to alendronate in reducing the incidence of new morphometric vertebral fractures and/or worsening of previous fractures in women over 65 years of age with recent clinical vertebral fracture or hip fracture caused by bone fragility after 52 weeks of treatment.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged > 65 years.
- •Recent (< 3 months) clinical vertebral fragility fracture confirmed by X-ray or recent (< 3 months) hip fragility fracture (femoral neck or trochanteric).
- •Patients who authorize their participation in the study by signing the written informed consent.
排除标准
- •Hypercalcaemia.
- •Severe vitamin D deficiency (25-hydroxyvitamin D < 10 ng/ml). If the serum concentration of 25-hydroxyvitamin D is 10-30 ng/ml, the patient may be included, but rapid supplementation with cholecalciferol or calcifediol will be carried out according to standard clinical practice.
- •Primary hyperparathyroidism.
- •Paget's disease of bone.
- •Contraindication to any of the treatments in the study.
- •Unexplained parathyroid hormone (PTH) elevation or alkaline phosphatase (ALP).
- •Previous use of intravenous zoledronate in the 52 weeks before inclusion in the study, intravenous ibandronate or pamidronate in the 3 months before inclusion in the study, denosumab in the 52 weeks before inclusion in the study, or prior use of the parathyroid hormone, teriparatide, another analog hormone or sodium fluoride at therapeutic doses at any time. Previous treatment with other antiosteoporotic drugs is permitted, provided that they are not being taken at the time of inclusion in the study.
- •Having received at least 1 dose of romosozumab at any previous time.
- •Patients who, for any reason (cognitive, socio-economic, etc.), have particular difficulties adhering to treatment
- •Having suffered two or more previous vertebral fractures*
- •Patients who, due to their characteristics and according to the doctor's criteria, could benefit more from treatment for osteoporosis other than those in the study, such as denosumab or zoledronic acid** * in these patients, it might be more justified to treat with teriparatide rather than with bisphosphonates ** denosumab might be preferable in patients with renal insufficiency, documented intolerance or contraindication to oral bisphosphonates, polypharmacy or who prefer subcutaneous administration every 6 months to daily treatment; zoledronic acid may be preferable in patients with documented intolerance or contraindication to oral bisphosphonates, polypharmacy, and bedridden patients or those with severe functional impairment.
结局指标
主要结局
The main evaluation criterion will be the percentage of patients with at least one new morphometric vertebral fracture (incident vertebral fractures) or the increase in severity of a known vertebral fracture (vertebral re-fracture) during the 52-week study period. For the diagnosis and grading of vertebral fractures, the Genant semi-quantitative method will be used on thoracic and lumbar radiographs.
The main evaluation criterion will be the percentage of patients with at least one new morphometric vertebral fracture (incident vertebral fractures) or the increase in severity of a known vertebral fracture (vertebral re-fracture) during the 52-week study period. For the diagnosis and grading of vertebral fractures, the Genant semi-quantitative method will be used on thoracic and lumbar radiographs.
次要结局
- new morphometric vertebral fractures or increased severity of a known vertebral fracture new clinical vertebral fractures; new non-vertebral fractures and new major non-vertebral fractures; change in BMD with respect to baseline; with respect to baseline; vertebral pain through the VAS-pain with respect to baseline & evaluation of therapeutic adherence; quality of life using the EQ-5D questionnaire with respect to baseline; frequency of AEs, SAEs, and AEs leading to treatment discontinuation
研究者
Elisabet Augé Marí
Scientific
Gedeon Richter Iberica S.A.
研究点 (20)
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