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The Effects of Potassium Citrate on Bone Metabolism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00357331
First received: July 25, 2006
Last updated: May 11, 2017
Last verified: May 2017
  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
Intervention Model: Parallel Assignment
Intervention Model Description:
Double Blind Placebo Controlled Trial
Masking: Participant, 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:


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

Primary Outcome Measures:
  • Urinary-N-telopeptide [ Time Frame: Baseline,1,3,6,12 months ]
    One measure of bone turnover was urinary-NTX as a second void morning urine.

  • P1NP (Amino-terminal Propeptide of Type I Procollagen) [ Time Frame: Baseline,1,3,6,12 months ]
    One measure of bone turnover was P1NP as a morning lab draw.


Secondary Outcome Measures:
  • Number of Participants With Stable Bone Mineral Density (BMD) Over 12 Months at All Sites. [ Time Frame: 1 year ]
    BMD was performed at lumbar spine, total hip and femoral neck using dual-energy X-ray Absorptiometry (DXA) Hologic; Bedford, Massachusetts.


Enrollment: 83
Actual Study Start Date: August 2006
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Potassium Citrate
Potassium Citrate 20 meq twice daily
Drug: potassium citrate
20 meq by mouth in capsule form twice daily
Other Name: uro cit
Placebo Comparator: Placebo
Placebo
Drug: potassium citrate
20 meq by mouth in capsule form twice daily
Other Name: uro cit

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357331

Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Naina Sinha Gregory, M.D. Weill Medical College of Cornell University
  More Information

Publications:
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00357331     History of Changes
Other Study ID Numbers: 0604008486
Study First Received: July 25, 2006
Results First Received: February 21, 2017
Last Updated: May 11, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Osteoporosis, Postmenopausal
Metabolic Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Citric Acid
Potassium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Expectorants
Respiratory System Agents

ClinicalTrials.gov processed this record on July 26, 2017