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

Kantonsspital Baselland Bruderholz

Status and phase

Completed

Phase 3

Conditions

Healthy

Treatments

Drug: potassium citrate

Study type

Interventional

Funder types

Other

Identifiers

NCT00509405

316/06

NFP 53: 4053-110259

Details and patient eligibility

About

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).

Full 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.

Enrollment

202 patients

Sex

All

Ages

65 to 80 years old

Volunteers

Accepts Healthy Volunteers

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