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Bone Diseases, Metabolic | The Effects of Potassium Citrate on Bone Metabolism

Bone Diseases, Metabolic research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Bone Diseases, Metabolic

Osteoporosis, Postmenopausal

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:potassium citrate20 meq by mouth in capsule form twice daily

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Potassium CitratePotassium Citrate 20 meq twice daily

PlaceboPlacebo

Study Status

Completed

Start Date: August 2006

Completed Date: April 2011

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Urinary-N-telopeptide

Secondary Outcome: Number of Participants With Stable Bone Mineral Density (BMD) Over 12 Months at All Sites.

Study sponsors, principal investigator, and references

Principal Investigator: Naina Sinha Gregory, M.D.

Lead Sponsor: Weill Medical College of Cornell University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00357331

Gregory NS, Kumar R, Stein EM, Alexander E, Christos P, Bockman RS, Rodman JS. POTASSIUM CITRATE DECREASES BONE RESORPTION IN POSTMENOPAUSAL WOMEN WITH OSTEOPENIA: A RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL. Endocr Pract. 2015 Dec;21(12):1380-6. doi: 10.4158/EP15738.OR. Epub 2015 Sep 24.

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