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The Effects of Potassium Citrate on Bone Metabolism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00357331
First received: July 25, 2006
Last updated: November 4, 2010
Last verified: November 2010
History of Changes
  Purpose

Skeletal buffering of chronic acid loads may contribute to a significant amount of bone loss over time. Evidence from a few small short-term studies suggests that basic compounds, namely potassium citrate and potassium bicarbonate may reduce bone loss and improve bone density.

The purpose of this study is to evaluate the effects of potassium citrate on bone metabolism. We hypothesize that administration of potassium citrate to postmenopausal women with osteopenia will reduce bone resorption and improve bone mineral density.

Postmenopausal women with osteopenia (T score between -1.0 and -2.5) and no history of fracture will be randomized to either daily potassium citrate or placebo for one year. Primary outcomes will be markers of bone turnover, which will be measured over 12 months. Secondary outcomes will be bone mineral density, compliance, and adverse events.


Condition Intervention Phase
Bone Diseases, Metabolic
Osteoporosis, Postmenopausal
 Drug: potassium citrate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Placebo Controlled Double Blind Investigation of the Effects of Potassium Citrate on Bone Metabolism in Postmenopausal Osteopenia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Bone turnover markers [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone Density by DEXA [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: July 2006
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: potassium citrate
    20 meq by mouth in capsule form twice daily
  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Postmenopausal women, more than 2 years post menopause
  • Osteopenia, defined as a T score at the lumbar spine or total hip between -1.0 and -2.5
  • No history of prior fragility fracture

Exclusion criteria:

  • Renal insufficiency
  • Use of potassium sparing diuretics
  • Use of potassium supplements
  • Hyperkalemia
  • Secondary causes of osteoporosis or metabolic bone disease
  • Delayed gastric emptying
  • esophageal compression, intestinal obstruction or stricture
  • use of anticholinergic medication
  • active urinary tract infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357331

Contacts
Contact: Kara Rysman, M.D. rysmank@mskcc.org

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Kara Rysman, M.D.         rysmank@mskcc.org    
Principal Investigator: Naina Sinha, M.D.            
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Naina Sinha, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Naina Sinha, M.D., Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00357331     History of Changes
Other Study ID Numbers: 0604008486
Study First Received: July 25, 2006
Last Updated: November 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
postmenopausal osteopenia
treatment
bone loss

Additional relevant MeSH terms:
Bone Diseases
Bone Diseases, Metabolic
Metabolic Diseases
Osteoporosis
Osteoporosis, Postmenopausal
Musculoskeletal Diseases
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 May 19, 2013