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

April 23, 2012 updated by: Reto Krapf, Kantonsspital Baselland Bruderholz

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • BL
      • Bruderholz/Basel, BL, Switzerland, CH-4101
        • Department of medicine, Kantonsspital Bruderholz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Potassium citrate
Drug: potassium citrate
6 times 10 mEq per day, oral for 24 months

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect on BMD at hip and total body Effect on 24h ambulatory blood pressure
Time Frame: 12 and 24 months
12 and 24 months
effect on skeletal muscle mass and strength
Time Frame: 12 and 24 months
12 and 24 months
effect on left ventricular muscle mass
Time Frame: 24 months
24 months
effect on carotid media-intima thickness
Time Frame: 24 months
24 months
Hypoxia-induced endothelial vasorelaxation
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Baselland Bruderholz

Investigators

  • Principal Investigator: Reto Krapf, MD, Department of Medicine, Kantonsspital Bruderholz, CH-4101 Bruderholz/Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

July 30, 2007

First Submitted That Met QC Criteria

July 30, 2007

First Posted (Estimate)

July 31, 2007

Study Record Updates

Last Update Posted (Estimate)

April 24, 2012

Last Update Submitted That Met QC Criteria

April 23, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 316/06
  • NFP 53: 4053-110259

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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