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临床试验/NCT01475214
NCT01475214已完成2 期

Musculoskeletal Benefits of Bicarbonate in Older Adults - A Dose-Finding Trial

Tufts University2 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
244
试验地点
2
主要终点
The Dose of Potassium Bicarbonate Needed for Maximal Suppression of 24-hr Urinary N-telopeptide

研究概览

简要总结

With aging, men and women develop a mild and progressive metabolic acidosis. This occurs as a result of declining renal function and ingestion of acid-producing diets. There is extensive evidence that severe metabolic acidosis causes bone and muscle loss, but the impact of the chronic, mild acidosis on bone and muscle in older individuals has not been established. In a recent study, administration of a single dose of bicarbonate daily for 3 months significantly reduced urinary excretion of N-telopeptide (NTX), a marker of bone resorption and urinary nitrogen, a marker of muscle wasting and improved muscle performance in the women but not the men. These and other data support a potential role for bicarbonate as a means of reducing the musculoskeletal declines that lead to extensive morbidity and mortality in the elderly. Before proceeding to a long-term bicarbonate intervention study, however, it is important to identify the dose of bicarbonate most likely to be optimal and to characterize the subjects who benefit most from it. This double blind, placebo controlled, dose-finding study will evaluate the effects of placebo and two doses of bicarbonate on urinary NTX and nitrogen excretion and on lower extremity performance over a 3 month period in 138 men and 138 women, age 60 and older. Changes in urinary excretion of NTX and nitrogen and in selected measures of lower extremity performance will be compared across the three groups. The safety and tolerability of the interventions will also be evaluated. This investigation should provide needed information on the appropriate dosing regimen for men and women and on the study population that should be enrolled in a future bicarbonate intervention trial to assess the long-term effects of this simple, low cost intervention on important clinical outcomes including rates of loss in bone and muscle mass, falls, and fractures.

详细描述

This dose-finding study will evaluate the effects of placebo and two doses of bicarbonate on urinary NTX and nitrogen excretion and on lower extremity performance over a three month period. The lower dose is similar to the dose shown in our recent trial to be effective. This study is a double blind, randomized, placebo-controlled, parallel-group trial in which 138 healthy men and 138 women, age 60 and older, will take potassium bicarbonate in doses of 1.0 or 1.5 mmol/kg of body weight or placebo daily for three months. Changes in urinary excretion of NTX and nitrogen and in measures of lower extremity performance will be compared across the three groups. The safety and tolerability of the interventions will also be evaluated. This investigation should provide needed information on the appropriate dosing regimen and on the study population that should be enrolled in a future bicarbonate intervention trial to assess the long-term effects of this simple, low cost intervention on important clinical outcomes including rates of loss in bone and muscle mass, falls, and fractures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • men and women
  • age 60 and older
  • community dwelling
  • women 1 yr since last menses

排除标准

  • Medications:
  • Oral glucocorticoids for > 10 days in the last 3 months
  • Cortef (hydrocortisone)
  • Prednisone
  • Parenteral glucocorticoids
  • Decadron (dexamethasone)
  • Osteoporosis medications in the last 6 months
  • Forteo (teriparatide)
  • Calcimar, Miacalcin (calcitonin)
  • Evista (raloxifene)
  • Osteoporosis medications in the last 2 years
  • Fosamax (alendronate)
  • Didronel (etidronate)
  • Aredia (pamidronate)
  • Actonel (risedronate)
  • Reclast (zoledronate)
  • Tamoxifen in the last 6 months
  • Calcium/Parathyroid
  • Rocaltrol (calcitriol)
  • Zemplar (paricalcitol)
  • Drisdol, Ergocalciferol
  • Diuretics currently
  • hydrocholorothiazide (HCTZ)
  • Diuril (chlorothiazide)
  • Thalitone (chlorthalidone)
  • Zaroxolyn (metolazone)
  • Moduretic
  • Lasix (forosamine)
  • Dyrenium (triamterene)
  • Testosterone or estrogen in the last 6 months (vaginal estrogen okay)
  • Angiotensin converting enzyme (ACE) inhibitors currently
  • Benazepril (Lotensin)
  • Captopril (Capoten)
  • Enalapril (Vasotec)
  • Fosinopril (Monopril)
  • Lisinopril (Prinivil, Zestril)
  • Moexipril (Univasc)
  • Perindopril (Aceon)
  • Quinapril (Accupril)
  • Ramipril (Altace)
  • Trandolapril (Mavik)
  • Angiotensin II receptor blockers currently
  • Candesartan (Atacand)
  • Eprosartan (Teveten)
  • Irbesartan (Avapro)
  • Losartan (Cozaar)
  • Olmesartan (Benicar)
  • Telmisartan (Micardis)
  • Valsartan (Diovan)
  • Over-the-Counter Drugs currently
  • 另有 23 项未显示

结局指标

主要结局

The Dose of Potassium Bicarbonate Needed for Maximal Suppression of 24-hr Urinary N-telopeptide

时间窗: 84 days

Describe and compare changes in urinary N-telopeptide (NTX) across the placebo and Potassium Bicarbonate (KHCO3) doses.

Co-primary Aim - to Identify the Dose of KHCO3 Needed for Maximal Suppression of 24-hr Urinary Nitrogen

时间窗: 84 days

Describe and compare changes in 24-hour urinary nitrogen in the low and high dose and KHCO3 group and in placebo.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bess Dawson-Hughes

Professor of Medicine

Tufts University

研究点 (2)

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