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Efficacy of Potassium Citrate in the Treatment of Postmenopausal Osteopenia

NCT02731820 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-11-12

Study results available
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Summary

The purpose of this study is to investigate whether the use of alkali compounds, i.e. potassium citrate (K3C6H5O7, hereinafter KCitr) is effective in preventing the progression of osteopenia.

A randomized clinical trial (RCT, placebo-controlled, double-blind) has been planned to evaluate the effect of the daily administration of KCitr (3 g/die, K 30 mEq).

The efficacy will be evaluated by comparing the circulating levels of bone turnover markers at the baseline and after the treatment (3, 6 months).

Conditions

  • Osteopenia
  • Bone Disease, Metabolic

Interventions

DIETARY_SUPPLEMENT

Potassium citrate

Kcitr 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)

DIETARY_SUPPLEMENT

Placebo

Excipients: 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)

DIETARY_SUPPLEMENT

Vitamin D3

400 IU/die Vitamin D3 daily by mouth

DIETARY_SUPPLEMENT

Calcium carbonate

500 mg/die calcium carbonate daily by mouth

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Principal Investigators

  • Nicola Baldini, MD, Prof. · Istituto Ortopedico Rizzoli

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-01
Primary Completion
2017-08-30
Completion
2017-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02731820 on ClinicalTrials.gov