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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reto Krapf, Kantonsspital Bruderholz
ClinicalTrials.gov Identifier:
NCT00509405
First received: July 30, 2007
Last updated: April 23, 2012
Last verified: April 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Neutralization of Endogenous Acid Production on Bone Mineral Density and Microarchitectural Composition of Bone in Humans

Resource links provided by NLM:


Further study details as provided by Kantonsspital Baselland Bruderholz:

Primary Outcome Measures:
  • BMD at L2-L4 by DEXA and microarchitectural composition of bone in both tibias and radius [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect on BMD at hip and total body Effect on 24h ambulatory blood pressure [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • effect on skeletal muscle mass and strength [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • effect on left ventricular muscle mass [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • effect on carotid media-intima thickness [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Hypoxia-induced endothelial vasorelaxation [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 202
Study Start Date: July 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Potassium citrate 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

Locations
Switzerland
Department of Medicine, Kantonsspital Bruderholz
Bruderholz/Basel, BL, Switzerland, CH-4101
Sponsors and Collaborators
Kantonsspital Baselland Bruderholz
Investigators
Principal Investigator: Reto Krapf, MD Department of Medicine, Kantonsspital Bruderholz, CH-4101 Bruderholz/Switzerland
  More Information

Additional Information:
No publications provided

Responsible Party: Reto Krapf, Professor of Medicine, Kantonsspital Bruderholz
ClinicalTrials.gov Identifier: NCT00509405     History of Changes
Other Study ID Numbers: 316/06, NFP 53: 4053-110259
Study First Received: July 30, 2007
Last Updated: April 23, 2012
Health Authority: Switzerland: "Steering committee of the Swiss National Foundation NFP 53"

Keywords provided by Kantonsspital Baselland 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:
Citric Acid
Potassium Citrate
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Expectorants
Respiratory System Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 16, 2014