Clinical trial NCT00509405: Effect of Neutralization of Endogenous Acid Production on BMD and Bone Microarchitectural
Official title: Effect of Neutralization of Endogenous Acid Production on Bone Mineral Density and Microarchitectural Composition of Bone in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Endogenous acid production
metabolic acidosis
potassium citrate
osteoporosis
sarcopenia
hypertension
Effect of potassium citrate on bone mineral density and bone mass
Lead sponsor: Kantonsspital Baselland Bruderholz
Sponsor class: OTHER
First posted: 2007-07-31
Enrollment: 202
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: BMD at L2-L4 by DEXA and microarchitectural composition of bone in both tibias and radius
timeFrame: 12 and 24 months
Secondary outcomes:
measure: Effect on BMD at hip and total body Effect on 24h ambulatory blood pressure
timeFrame: 12 and 24 months
measure: effect on skeletal muscle mass and strength
timeFrame: 12 and 24 months
measure: effect on left ventricular muscle mass
timeFrame: 24 months
measure: effect on carotid media-intima thickness
timeFrame: 24 months
measure: Hypoxia-induced endothelial vasorelaxation
timeFrame: 24 months
Other outcomes:
Locations:
city: Bruderholz/Basel
country: Switzerland
facility: Department of Medicine, Kantonsspital Bruderholz
state: BL
Study officials:
affiliation: Department of Medicine, Kantonsspital Bruderholz, CH-4101 Bruderholz/Switzerland
name: Reto Krapf, MD
role: PRINCIPAL_INVESTIGATOR
References: