CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 83 enrolled
Drug / intervention
potassium citratedrug
Likely dose
Potassium citrate 20 mEq orally twice daily (in capsule form)AI-extracted
Key inclusion· 3
  • Postmenopausal women at least 2 years past menopause
  • Osteopenia defined as T-score between -1.0 and -2.5 at lumbar spine or total hip
  • No prior fragility fractures
Key exclusion· 9
  • Renal insufficiency
  • Use of potassium-sparing diuretics
  • Use of potassium supplements
  • Hyperkalemia

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00357331
NCT00357331Phase 4Completed

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

Weill Medical College of Cornell University·interventional·Posted Jul 27, 2006·Updated Jun 12, 2017

In Brief

A Phase 4 clinical trial evaluating potassium citrate for Bone Diseases, Metabolic and Osteoporosis, Postmenopausal. Completed, enrolled 83 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 27, 2006
Enrollment StartAug 1, 2006
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 19.9 years ago

Interventions

potassium citratedrug

20 meq by mouth in capsule form twice daily