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

NCT00509405 | Completed Phase 3

• 2 other identifiers: 316/06NFP 53: 4053-110259
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

Endogenous acid production; metabolic acidosis; potassium citrate; osteoporosis; sarcopenia; hypertension; Effect of potassium citrate on bone mineral density and bone mass

Outcome Measures

Primary Outcomes (1)

• BMD at L2-L4 by DEXA and microarchitectural composition of bone in both tibias and radius

  12 and 24 months

Secondary Outcomes (5)

• Effect on BMD at hip and total body Effect on 24h ambulatory blood pressure

  12 and 24 months

• effect on skeletal muscle mass and strength

  12 and 24 months

• effect on left ventricular muscle mass

  24 months

• effect on carotid media-intima thickness

  24 months

• Hypoxia-induced endothelial vasorelaxation

  24 months

Study Arms (1)

Potassium citrate

PLACEBO COMPARATOR

Drug: potassium citrate

Interventions

potassium citrate DRUG

6 times 10 mEq per day, oral for 24 months

Potassium citrate

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Men and women, 65 to 80y, tscores at L2-L4 0 to -2.5

You may not qualify if:

• 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

Sponsors & Collaborators

• Kantonsspital Baselland Bruderholz: lead

Study Sites (1)

Department of Medicine, Kantonsspital Bruderholz

Bruderholz/Basel, Basel-Landschaft, CH-4101, Switzerland

Location

Related Links

• check in archive for "essen wir zu sauer"

MeSH Terms

Conditions

Acidosis; Osteoporosis; Sarcopenia; Hypertension

Interventions

Potassium Citrate

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Reto Krapf, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 30, 2007
• First Posted: July 31, 2007
• Study Start: July 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 24, 2012

Record last verified: 2012-04

Locations

CH (1)