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

Phase 3

Completed

• Conditions: Healthy
• Interventions: Drug: potassium citrate

• Registration Number: NCT00509405
• Lead Sponsor: Kantonsspital Baselland Bruderholz

Brief Summary

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

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 Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-30
• Study First Submitted QC: 2007-07-30
• Study First Posted: 2007-07-31
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-23
• Last Update Posted: 2012-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Potassium citrate	potassium citrate	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Medicine, Kantonsspital Bruderholz; 🇨🇭 Bruderholz/Basel, BL, Switzerland