Official Title: “A Randomized Placebo Controlled Double Blind Investigation of the Effects of Potassium Citrate on Bone Metabolism in Postmenopausal Osteopenia”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

• Drug: potassium citrate
  • 20 meq by mouth in capsule form twice daily

Primary Measures

• Bone turnover markers
  • Time Frame: 1 year
    Safety Issue?: No

Secondary Measures

• Bone Density by DEXA
  • Time Frame: 1 year
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Weill Medical College of Cornell University

Overall Clinical Trial Officials and Contacts

Naina Sinha, M.D. Principal Investigator Weill-Cornell Medical Center  

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

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00357331

Study ID Number: 0604008486

ClinicalTrials.gov Identifier: NCT00357331

Health Authority: United States: Institutional Review Board