NCT04905277已完成2 期
Beta1-Selective Blockade for Prevention of Postmenopausal Bone Loss: A Phase 2, Multi-Center, Double-Blinded, Randomized Placebo-Controlled Trial
Sundeep Khosla, M.D.3 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2021年7月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 试验地点
- 3
- 主要终点
- Primary Outcome: Percent change in total hip bone mineral density (BMD)
研究概览
简要总结
Evaluate whether treatment with a widely used beta blocker, atenolol, will prevent bone loss at the lower back and hip in postmenopausal women.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Able and willing to provide informed consent
- •Postmenopausal women (FSH ≥ 16 IU/L) (no menses for at least one year)
- •Aged 50-75 years
排除标准
- •Clinical diagnosis of diabetes mellitus requiring insulin
- •Clinically significant abnormality in any of the additional screening laboratory studies
- •Calcium - > upper limit lab value per site
- •AST- 2x upper normal limit
- •FSH- < 16IU/L
- •eGFR- < 45 mL/min/1.73m2 based on creatinine
- •CBC- Per PI interpretation of each patient
- •Presence of (documented clinical diagnosis of any of the following):
- •Significant liver or renal disease
- •Malignancy (current diagnosis including myeloma or melanoma)
- •Radiation (the site PI will determine eligibility on a case-by-case basis)
- •Malabsorption (current clinical diagnosis or actively receiving treatment)
- •Hypoparathyroidism (current clinical diagnosis or actively receiving treatment)
- •Hyperparathyroidism (current clinical diagnosis or actively receiving treatment)
- •Acromegaly
- •Cushing syndrome
- •Hypopituitarism
- •Severe chronic obstructive pulmonary disease
- •Pheochromocytoma (current clinical diagnosis or actively receiving treatment)
- •History of cardiac failure
- •Ejection Fraction <35% (based on most recent EF within the last 12 months, if available)
- •PR interval > 200 msec on screening ECG or known heart block
- •History of bronchospastic disease with treatment (asthma, bronchitis)
- •Gastric Bypass
- •Parkinson's
- •Rheumatoid Arthritis
- •Psoriatic Arthritis
- •Connective Tissue disease
- •Undergoing treatment with any medications that affect bone turnover, including the following:
- •adrenocorticosteroids (oral for > 3 months within the past year or year-round use of inhaled corticosteroid use)
- •anticonvulsant therapy for seizures (carbamazepine, phenobarbital, or phenytoin within the previous year) pharmacological doses of: thyroid hormone (causing decline of thyroid stimulating hormone below normal, i.e. < 0.3 miU/L) bisphosphonates (within the past 3 yrs; if taken orally >1 month in past 3 years) denosumab, romosozumab, estrogen therapy (does not include creams or suppositories) or treatment with a selective estrogen receptor modulator, or teriparatide/abaloparatide (> 1 month within the past year); aromatase inhibitors (>1 month within the past year)
- •Current use of digitalis glycosides
- •Thiazides (< 6 months of use prior to screening)
- •Current or within the past 3 months use of beta blockers
- •Any recent fracture within the past 6 months prior to screening (other than fingers, toes and facial fractures, which are all acceptable)
- •Bilateral hip replacements or metal in both hips
- •Patients with serum 25-hydroxyvitamin D levels of < 20 ng/ml, in order to ensure vitamin D sufficiency
- •Resting systolic blood pressure < 115 mm Hg, heart rate < 55 bpm (average of 3 readings after a 5-minute rest and one minute between readings with an automatic cuff)
研究组 & 干预措施
Atenolol
Experimental
Study subjects will take Atenolol 50 mg daily over 2 years
干预措施: Atenolol 50 MG (Drug)
Placebo
Placebo Comparator
Study subjects will take a placebo daily over 2 years
干预措施: Placebo (Drug)
结局指标
主要结局
Primary Outcome: Percent change in total hip bone mineral density (BMD)
时间窗: Baseline, 24 months
Percent change in total hip bone mineral density (BMD) by DXA
次要结局
- Additional secondary outcomes(Baseline, intermediate timepoints, 24 months)
- Secondary Outcomes: Percent changes in lumbar spine and femur neck BMD(Baseline, 24 months)
研究者
Sundeep Khosla, M.D.
Dr. Francis Chucker and Nathan Landow Research Professor Distinguished Mayo Investigator
Mayo Clinic
研究点 (3)
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