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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00509405
• Other study ID #: 316/06
• Secondary ID: NFP 53: 4053-110
• Status: Completed
• Phase: Phase 3
• First received: July 30, 2007
• Last updated: April 23, 2012
• Start date: July 2007
• Est. completion date: May 2010

Study information

• Verified date: April 2012
• Source: Kantonsspital Baselland Bruderholz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: "Steering committee of the Swiss National Foundation NFP 53"
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• potassium citrate
6 times 10 mEq per day, oral for 24 months

Locations

Country	Name	City	State
Switzerland	Department of Medicine, Kantonsspital Bruderholz	Bruderholz/Basel	BL

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Baselland Bruderholz

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMD at L2-L4 by DEXA and microarchitectural composition of bone in both tibias and radius		12 and 24 months	No
Secondary	Effect on BMD at hip and total body Effect on 24h ambulatory blood pressure		12 and 24 months	No
Secondary	effect on skeletal muscle mass and strength		12 and 24 months	No
Secondary	effect on left ventricular muscle mass		24 months	No
Secondary	effect on carotid media-intima thickness		24 months	No
Secondary	Hypoxia-induced endothelial vasorelaxation		24 months	No

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