The Effects of Potassium Citrate on Bone Metabolism

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Citric Acid; Potassium Citrate

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.