Effect of Neutralization of Endogenous Acid Production on Bone Mineral Density and Microarchitectural Composition of Bone - Full Text View

Sponsor:	Kantonsspital Bruderholz
Information provided by:	Kantonsspital Bruderholz
ClinicalTrials.gov Identifier:	NCT00509405

Purpose

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).

Condition	Intervention	Phase
Healthy	Drug: potassium citrate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Minerals

Drug Information available for: Citric acid Potassium citrate Sodium Citrate Potassium chloride

U.S. FDA Resources

Further study details as provided by Kantonsspital Bruderholz:

Primary Outcome Measures:

BMD at L2-L4 by DEXA microarchitectural composition of bone in both tibias and radius [ Time Frame: 12 and 24 months ]

Secondary Outcome Measures:

Effect on BMD at hip and total body Effect on 24h ambulatory blood pressure [ Time Frame: 12 and 24 months ]
effect on skeletal muscle mass and strength [ Time Frame: 12 and 24 months ]
effect on left ventricular muscle mass [ Time Frame: 24 months ]
effect on carotid media-intima thickness [ Time Frame: 24 months ]

Estimated Enrollment:	140
Study Start Date:	July 2007
Estimated Study Completion Date:	March 2010

Arms	Assigned Interventions
Potassium citrate: Placebo Comparator	Drug: potassium citrate 6 times 10 mEq per day, oral for 24 months

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

Ages Eligible for Study:	65 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509405

Contacts

Contact: Sigrid Jehle, MD

0041614363636

sigrid.jehle@ksbh.ch

Locations

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

Sponsors and Collaborators

Kantonsspital Bruderholz

Investigators

Principal Investigator:

Reto Krapf, MD

Department of Medicine, Kantonsspital Bruderholz, CH-4101 Bruderholz/Switzerland

More Information

No publications provided

Study ID Numbers:	316/06, NFP 53: 4053-110259
Study First Received:	July 30, 2007
Last Updated:	July 30, 2007
ClinicalTrials.gov Identifier:	NCT00509405 History of Changes
Health Authority:	Steering committee of NFP53 of the Swiss National Science Foundation, Switzerland `:`

Keywords provided by Kantonsspital Bruderholz:

Endogenous acid production
metabolic acidosis
potassium citrate
osteoporosis

sarcopenia
hypertension
Effect of potassium citrate on bone mineral density and bone mass

Additional relevant MeSH terms:

Respiratory System Agents
Potassium Citrate
Natriuretic Agents
Therapeutic Uses
Expectorants

Physiological Effects of Drugs
Diuretics
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009