The Effects of Potassium Citrate on Bone Metabolism

Osteoporosis, Postmenopausal Clinical Trial

Official title:

A Randomized Placebo Controlled Double Blind Investigation of the Effects of Potassium Citrate on Bone Metabolism in Postmenopausal Osteopenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00357331
• Other study ID #: 0604008486
• Status: Recruiting
• Phase: Phase 4
• First received: July 25, 2006
• Last updated: November 4, 2010
• Start date: July 2006

Study information

• Verified date: November 2010
• Source: Weill Medical College of Cornell University
• Contact: Kara Rysman, M.D.
• Email: rysmank[@]mskcc.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Metabolic Diseases
• Osteoporosis, Postmenopausal

Intervention

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

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone turnover markers		1 year	No
Secondary	Bone Density by DEXA		1 year	No