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

Kantonsspital Baselland Bruderholz202 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

202

Conditions

Healthy

Interventions

potassium citrateDRUG

6 times 10 mEq per day, oral for 24 months

Eligibility

Sex: ALLMin age: 65 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of Medicine, Kantonsspital Bruderholz

Bruderholz/Basel, Basel-Landschaft, Switzerland

Outcomes

Primary Outcomes

BMD at L2-L4 by DEXA and microarchitectural composition of bone in both tibias and radius

Time frame: 12 and 24 months

Secondary Outcomes

Effect on BMD at hip and total body Effect on 24h ambulatory blood pressure

Time frame: 12 and 24 months

effect on skeletal muscle mass and strength

Time frame: 12 and 24 months

effect on left ventricular muscle mass

Time frame: 24 months

effect on carotid media-intima thickness

Time frame: 24 months

Hypoxia-induced endothelial vasorelaxation

Time frame: 24 months

Data from ClinicalTrials.gov

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