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Effect of Neutralization of Endogenous Acid Production on Bone Mineral Density and Microarchitectural Composition of Bone
This study is currently recruiting participants.
Study NCT00509405   Information provided by Kantonsspital Bruderholz
First Received: July 30, 2007   No Changes Posted

July 30, 2007
July 30, 2007
July 2007
 
BMD at L2-L4 by DEXA microarchitectural composition of bone in both tibias and radius [ Time Frame: 12 and 24 months ]
Same as current
No Changes Posted
  • 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 ]
Same as current
 
Effect of Neutralization of Endogenous Acid Production on Bone Mineral Density and Microarchitectural Composition of Bone
 

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.

Phase III
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Healthy
Drug: potassium citrate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
140
March 2010
 

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
Both
65 Years to 80 Years
Yes
Contact: Sigrid Jehle, MD 0041614363636 sigrid.jehle@ksbh.ch
Switzerland
 
NCT00509405
 
316/06, NFP 53: 4053-110259
Kantonsspital Bruderholz
 
Principal Investigator: Reto Krapf, MD Department of Medicine, Kantonsspital Bruderholz, CH-4101 Bruderholz/Switzerland
Kantonsspital Bruderholz
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP