Clinical Study Evaluating Selective or Nonselective Beta Blockers Use and Fracture Risk in Patients With Primary Osteoporosis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of patients with fracture in each group
研究概览
简要总结
Clinical study evaluating selective or nonselective beta blockers use and fracture risk in patients with primary osteoporosis
详细描述
Clinical study evaluating selective or nonselective beta blockers use and if there is fracture risk in patients with primary osteoporosis
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Male & female osteoporotic patient aged ≥ 50 years
- •Hypertensive & normotensive patients
- •BMD T-score ≥ 2.5 or more SD below peak bone mass
排除标准
- •Patients on drugs that may improve osteoporosis disease state such as:
- •Angiotensin converting enzyme inhibitor (ACEI) or Angiotensin receptor blockers (ARBs), Thiazide diuretic, Nitrates, Spironolactone, Statins.
- •Patients on drugs that may worsen osteoporosis disease state such as:
- •Corticosteroids, Loop diuretics, Anticonvulsants, Antidepressants, Aromatase inhibitors, Thyroid replacement therapy and Proton pump inhibitors.
研究组 & 干预措施
nonselective beta blocker group
Twenty patients with osteoporosis and hypertension on the same treatment as control group in addition to propranolol (Inderal®) 10 mg once daily titrated as patient's response.
干预措施: nonselective beta blocker (Drug)
nonselective beta blocker group
Twenty patients with osteoporosis and hypertension on the same treatment as control group in addition to propranolol (Inderal®) 10 mg once daily titrated as patient's response.
干预措施: alendronate sodium (Drug)
cardio-selective beta blocker group
Twenty patients with osteoporosis and hypertension on the same treatment as control group in addition to bisoprolol (Concor®) 5 mg once daily titrated as patient's response.
干预措施: cardio-selective beta blocker group (Drug)
cardio-selective beta blocker group
Twenty patients with osteoporosis and hypertension on the same treatment as control group in addition to bisoprolol (Concor®) 5 mg once daily titrated as patient's response.
干预措施: alendronate sodium (Drug)
Control group
Ten patient with osteoporosis on alendronate sodium 70 mg (Fosamax®) once/week, vitamin D3 1 mcg once daily and calcium supplement 500 mg once daily.
干预措施: alendronate sodium (Drug)
结局指标
主要结局
Number of patients with fracture in each group
时间窗: 1 year
the exact number of patients with fracture in each group
次要结局
未报告次要终点
研究者
Sherief Abd-Elsalam
Ass. Prof. Tropical Medicine
Tanta University