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NCT06811363

Contribution of Bone to Urine Citrate

Enrolling by Invitation
Not specifiedAges 18+Observational
University of Texas Southwestern Medical Center
~25 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:Metabolic / prescribed dietKCit Load (40 meq)Anti-resorptive agentsAnabolic Agents

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Correlation of change in Urine Citrate levels to change in Potassium levels with change in bone turnover markers at 1 month after initiating treatment
Measured over Baseline, 1month after initiating treatment
+4 more outcomes measured

Conditions

Osteoporosis

Explore related trials

Osteoporosis

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Eleanor Lederer, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Osteoporosis naïve to treatment

Exclusion

eGFR \< 60 ml/min
chronic diarrhea or gastrointestinal illness

What this trial measures

  • Correlation of change in Urine Citrate levels to change in Potassium levels with change in bone turnover markers at 1 month after initiating treatmentBaseline, 1month after initiating treatment

    Change in Urine Citrate levels to change in Potassium levels from the 24h urine samples is measured and will be correlated with baseline and post treatment bone turnover markers by multiple linear regression modeling using forward and backward selection.

  • Correlation of change in Urine Citrate levels to change in Potassium levels with change in bone turnover markers at 6 months after initiating treatmentBaseline, 6 months after initiating treatment

    Change in Urine Citrate levels to change in Potassium levels from the 24h urine samples is measured and will be correlated with baseline and post treatment bone turnover markers by multiple linear regression modeling using forward and backward selection.

  • Correlation of change in Urine Citrate levels to change in Potassium levels with bone densitometry at baselineBaseline

    Change in Urine Citrate levels to change in Potassium levels will be correlated with bone densitometry at lumbar spine, right hip, and radius

  • Correlation of change in Urine Citrate levels to change in Potassium levels with change in bone densitometry at 6 months after initiating treatmentBaseline, 6 months after initiating treatment

    Change in Urine Citrate levels to change in Potassium levels will be correlated with change in bone densitometry at lumbar spine, right hip, and radius

  • K Cit loadPredose, 0.5, 1, 2, 3, 4 hours after drug administration in Phases 1, 2, 3

    The AUC for citrate will be calculated from the serum and urine levels based on the assumption that oral K Cit is 100% absorbed to estimate hepatic uptake effect on filtered load. The fractional excretion of citrate (FeCit) will be calculated from hourly serum and urine creatinine and citrate levels (FeCit = (serum Cit x Urine Cr)/urine Cit x serum Cr) x 100. Differences in FeCit will be correlated with ΔUcit/Δk and will be used to discriminate changes in ΔUcit/Δk due to filtered load vs renal handling.