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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: potassium citrate
  • 6 times 10 mEq per day, oral for 24 months

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Potassium citrate

Primary Measures

• BMD at L2-L4 by DEXA microarchitectural composition of bone in both tibias and radius
  • Time Frame: 12 and 24 months
    

Secondary Measures

• 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
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Kantonsspital Bruderholz

Overall Clinical Trial Officials and Contacts

Reto Krapf, MD Principal Investigator Department of Medicine, Kantonsspital Bruderholz, CH-4101 Bruderholz/Switzerland  

Overall Contact: Sigrid Jehle, MD 0041614363636 sigrid.jehle@ksbh.ch

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00509405

Study ID Number: 316/06

ClinicalTrials.gov Identifier: NCT00509405

Health Authority: Steering committee of NFP53 of the Swiss National Science Foundation, Switzerland `:`