Risedronate With High-dose Vitamin D Resolves Hyperparathyroidism and Hypovitaminosis D But Not Osteoporosis in Mexican Postmenopausal Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Remission of hyperparathyroidism
研究概览
简要总结
Osteoporosis is defined as a systemic disease of bone mineralization, characterized by a decrease in bone mineral density that causes bone fragility and increases the risk of fractures during menopause. Recently, a high prevalence of hypovitaminosis D has been found worldwide, which could trigger a state of secondary hyperparathyroidism that can worsen the state of postmenopausal patients with osteoporosis. An open-label, clinical trial was conducted in Mexican women with postmenopausal osteopenia-osteoporosis to determine the efficacy of the combined treatment with risedronate and high-dose vitamin D in improving bone mineral density, hyperparathyroidism, and hypovitaminosis D.
详细描述
Participants were selected from the climacteric clinic of the regional hospital "1ro de Octubre-Instituto de Seguridad y Servicios Sociales para Los Trabajadores del Estado (ISSSTE)", Mexico. All participants voluntarily accepted to be part of the study and provided written informed consent.This study was approved by the institutional ethical committee of the hospital with registration number COFEPRIS 17 CI 09005135 with the internal registration number 118.2021. Every participant was clinically examined. Their metabolic state was assessed by considering height, weight, body mass index (BMI) and the percentage of Hb1Ac.
33 patients were included among 40 to 78 years with the diagnosis of postmenopausal osteoporosis with associated hyperparathyroidism, hypovitaminosis D or both conditions. All the patients were treated for 6 months with 35 mg of risedronate and 2800 IU of vitamin D once a week, with additional daily supplementation of 4000 IU of vitamin D.
Statical analysis was performed using PAST 3.0 and GraphPad Prism 8.4.3. software. Some statical parameters, such as arithmetic median (µ), and standard deviation (S.D.) were calculated using Excel-Word. Graphics were constructed with GraphPad Prism 8.4.3 and tables were done in Excel-Word. The assigned α value for this study was <0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 78 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants with a diagnosis of postmenopausal osteoporosis or osteopenia.
- •Participants with a diagnosis of hyperparathyroidism or hypovitaminosis D.
- •Participants who accepted to participate and that provided informed consent.
排除标准
- •Participants with oncological pathologies.
- •Participants with recent fractures.
- •Participants with gastric intolerance or hypersensitivity to the drugs.
- •Participants were under treatment with another antiresorptive or bone-forming drug, or if they were receiving treatment with thiazide diuretics, lithium, teriparatide or glucocorticoids.
- •Participants with Addison's disease, pheochromocytoma or depressive disorders.
研究组 & 干预措施
Postmenopausal Osteopenia-osteoporosis patients
All participants were treated for 6 months with risedronate 35 mg and vitamin D 2800 IU once a week, with additional daily vitamin D supplementation of 4000 IU.
干预措施: Risedronate (Drug)
Postmenopausal Osteopenia-osteoporosis patients
All participants were treated for 6 months with risedronate 35 mg and vitamin D 2800 IU once a week, with additional daily vitamin D supplementation of 4000 IU.
干预措施: Vitamin D (Drug)
结局指标
主要结局
Remission of hyperparathyroidism
时间窗: 6 months
Remission of hyperparathyroidism was considered when serum parathyroid hormone \[PTH\] values were below 45 pg/mL.
Remission of hypovitaminosis D
时间窗: 6 months
Remission of hypovitaminosis D was considered when serum 25-hydroxy vitamin D \[25(OH)D\] was above 29 pg/ml.
Remission of osteopenia
时间窗: 6 months
Osteopenia remission was considered when densitometry T-score values were below -1.
Remission of Osteoporosis
时间窗: 6 months
Osteoporosis remission was considered when densitometry T-score values were below -2.4.
次要结局
- Change from baseline serum calcium at 6 months(6 months)
- Change from baseline serum phosphorus at 6 months(6 months)
- Change from baseline urinary calcium at 6 months(6 months)
- Change from bone resorption biomarker at 6 months(6 months)
- Fracture Risk Assessment Tool (FRAX®) for hip fracture(6 months)
- Fracture Risk Assessment Tool for major osteoporotic fracture (FRAX® Mo)(6 months)