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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Potassium citrate

Group Type PLACEBO_COMPARATOR

potassium citrate

Intervention Type DRUG

6 times 10 mEq per day, oral for 24 months

Interventions

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potassium citrate

6 times 10 mEq per day, oral for 24 months

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes