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Contribution of Bone to Urine Citrate

NCT06811363 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2026-02-17

No results posted yet for this study

Summary

Identification of the mechanisms by which bone contributes to urine citrate could lead to alternative explanations for and approaches to hypocitraturia. This proposal to explore the role of bone in urine citrate addresses the mission of the CMMCR to discover new mechanisms and innovative therapies for diseases of mineral metabolism. The results will be used to apply for extramural funding to further examine the nonrenal regulation of UCit.

Hypothesis: Serum citrate is a function of bone citrate formation dependent on both bone mass and bone turnover. 20 subjects with osteoporosis naïve to treatment will be identified to examine bone parameters that correlate with ΔUcit/Δk.

Use of potent anti-osteoporotic therapies to increase the likelihood of identifying significant bone turnover and BMD correlations with ΔUcit/Uk will take place in this study.

Plan to achieve the following aim:

* Correlate ∆ Ucit/∆k in response to acute KCit load with:

1. Bone turnover marker at baseline
2. BMD at baseline
3. Change in bone turnover markers at 1 month and 6 months with each osteoporosis treatment modality (anti-resorptive agents such as Zoledronic acid or Denosumab, or the Anabolic agent Romosozumab)
4. Change in bone mineral density at 6 with each osteoporosis treatment modality (anti-resorptive agents such as Zoledronic acid or Denosumab, or the Anabolic agent Romosozumab)

Conditions

Interventions

OTHER

Metabolic / prescribed diet

Instructed diet (400 mg Ca, 800 mg P, 100 mEq Na) and two liters of distilled water daily for three days (equilibration period), followed by a constant standardized meal with the same composition of Ca, P, and Na for one day. After 240hr urine sample collection patient fasted the preceding evening except for 300 ml of distilled water at 9 pm and 11 pm. On test days, 600 ml distilled water given and fasting blood obtained.

OTHER

KCit Load (40 meq)

Potassium citrate load of 40meq will be given after fasting blood has been obtained

DRUG

Anti-resorptive agents

Zoledronic acid or Denosumab (as prescribed by their physician)

DRUG

Anabolic Agents

Romosozumab (as prescribed by their physician)

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT06811363 on ClinicalTrials.gov