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Status:

COMPLETED

Musculoskeletal Effects of Bicarbonate

Lead Sponsor:

Tufts University

Collaborating Sponsors:

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Conditions:

Muscle Loss

Fractures

Eligibility:

All Genders

60+ years

Phase:

PHASE2

Brief Summary

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...

Detailed Description

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 ...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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)
  • Dyazide
  • Maxide
  • Moduretic
  • Lasix (forosamine)
  • Dyrenium (triamterene)
  • Midamor
  • 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
  • Antacids - any antacid that contains calcium carbonate, aluminum hydroxide, magnesium hydroxide, or calcium acetate - selected examples include
  • TUMS
  • Mylanta
  • Maalox
  • Titralac
  • Rolaids
  • Sodium bicarbonate (baking soda)
  • Note: magaldrate or Riopan® is allowed
  • Potassium supplements
  • Salt substitutes
  • Conditions/Diseases
  • renal disease including kidney stones in the past 5 years or glomerular filtration rate (GFR) \< 60 ml/min/1.73 m2
  • hyperkalemia (serum potassium \>5.3 meq/L; normal range 3.5-5.3 meq/L)
  • elevated serum bicarbonate (serum bicarbonate \> 29 mmol/L; normal range 22-29 mmol/L)
  • cirrhosis
  • gastroesophageal reflux disease (GERD) requiring treatment with alkali-containing antacids (TUMS, Mylanta, Maalox, Titralac, Rolaids, or sodium bicarbonate)
  • hyperparathyroidism
  • untreated thyroid disease
  • significant immune disorder such as rheumatoid arthritis
  • current unstable heart disease
  • active malignancy or cancer therapy in the last year
  • fasting spot urine calcium/creatinine \> 0.38 mmol/mmol after 1 wk off of calcium supplements
  • congestive heart failure, arrhythmias (surgically treated arrhythmias acceptable), or myocardial infarction in last 12 months
  • serum calcium outside the normal range of 8.3-10.2 mg/dl
  • uncontrolled diabetes mellitus (fasting blood sugar \> 130)
  • alcohol use exceeding 2 drinks/day
  • peptic ulcers or esophageal stricture
  • weight \<45 or \>113.5 kg (\<99 or \>249.7 lbs)
  • other abnormalities in screening labs, at discretion of the study physician (the PI)

Key Trial Info

Start Date :

January 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2015

Estimated Enrollment :

244 Patients enrolled

Trial Details

Trial ID

NCT01475214

Start Date

January 1 2012

End Date

August 1 2015

Last Update

October 19 2015

Active Locations (1)

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1

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, United States, 02111