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Completed

NCT Number: NCT00509405

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

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).

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Key information

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

potassium citrate

Drug

6 times 10 mEq per day, oral for 24 months

Primary outcomes

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

    Time frame: 12 and 24 months

Secondary outcomes

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

    Time frame: 12 and 24 months

  2. effect on skeletal muscle mass and strength

    Time frame: 12 and 24 months

  3. effect on left ventricular muscle mass

    Time frame: 24 months

  4. effect on carotid media-intima thickness

    Time frame: 24 months

  5. Hypoxia-induced endothelial vasorelaxation

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Kantonsspital Baselland Bruderholz

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jul 31, 2007
Registry last updated
Apr 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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