Effect of Neutralization of Endogenous Acid Production on BMD and Bone Microarchitectural

Study Overview
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Brief Summary
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Hypothesis: Neutralization of acid production induced by the Western diet with oral administration of potassium citrate increases bone mineral density and bone mass as well as skeletal muscle mass and strength in elderly people (> 65y).

Detailed Description
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We will perform a prospective, randomized, placebo-controlled trial evaluating the effect of K citrate on bone mineral density, microarchitectural composition of bone,nutritional parameters, lean body mass, parameters of skeletal muscle mass and strength, 24h and exercise induced blood pressure changes in otherwise healthy, elderly ambulatory subjects of both genders. Potassium citrate (60 mEq) is supplied as tablets with a wax matrix (10 mEq of citrate per tablet) and ingested in three doses/day. All subjects will receive daily oral 500 mg of calcium and 400 IU of vitamin D to ensure adequate calcium and vitamin D supply.

Official Title
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Effect of Neutralization of Endogenous Acid Production on Bone Mineral Density and Microarchitectural Composition of Bone in Humans

Conditions
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Healthy

Intervention / Treatment
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* Drug: potassium citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, 65 to 80y, tscores at L2-L4 0 to -2.5 Exclusion Criteria: Treated or necessity to treat low BMD (t-score L2 to L4 <-2.5) Any major medical illness that would possibly need hospitalization and/or be followed by foreseeable complications within 12 months and/or have a life-expectancy of less than 5 years Stable serum creatinine > 150 umol/l and/or known Type IV renal-tubular acidosis (hyperkalemia) vegetarians concommitant drug prescriptions: systemic and topical glucocorticoids, systemically acting estrogens (topical allowed): both within the last 6 months. antiosteoporosis drugs: bisphosphoponates, fluoride, calcitonin, all within the previous 12 months. vitamin D deficiency at screening visit technical difficulties to delineate bone area of interest during the screening visit

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Potassium citrate<br> | Drug: potassium citrate<br>* 6 times 10 mEq per day, oral for 24 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMD at L2-L4 by DEXA and microarchitectural composition of bone in both tibias and radius |  | 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on BMD at hip and total body Effect on 24h ambulatory blood pressure |  | 12 and 24 months | 
| effect on skeletal muscle mass and strength |  | 12 and 24 months | 
| effect on left ventricular muscle mass |  | 24 months | 
| effect on carotid media-intima thickness |  | 24 months | 
| Hypoxia-induced endothelial vasorelaxation |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endogenous acid production, metabolic acidosis, potassium citrate, osteoporosis, sarcopenia, hypertension, Effect of potassium citrate on bone mineral density and bone mass