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

Condition(s) targeted: Healthy

Intervention: potassium citrate (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Kantonsspital Bruderholz

Official(s) and/or principal investigator(s):
Reto Krapf, MD, Principal Investigator, Affiliation: Department of Medicine, Kantonsspital Bruderholz, CH-4101 Bruderholz/Switzerland

Overall contact:
Sigrid Jehle, MD, Phone: 0041614363636, Email: sigrid.jehle@ksbh.ch

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).

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Primary outcome: BMD at L2-L4 by DEXA microarchitectural composition of bone in both tibias and radius

Secondary outcome:

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

effect on skeletal muscle mass and strength

effect on left ventricular muscle mass

effect on carotid media-intima thickness

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.

Minimum age: 65 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Sigrid Jehle, MD, Phone: 0041614363636, Email: sigrid.jehle@ksbh.ch

Department of Medicine, Kantonsspital Bruderholz, Bruderholz/Basel, BL CH-4101, Switzerland; Recruiting
Annie Kofmel, RN, Phone: 0041614363636, Email: annie.kofmel@ksbh.ch
sigrid jehle, MD, Phone: 0041614363636, Email: sigrid.jehle@ksbh.ch
Reto Krapf, MD, Principal Investigator

Starting date: July 2007
Ending date: March 2010
Last updated: July 30, 2007