Contribution of Bone to Urine Citrate

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06811363
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metabolic / prescribed diet — OTHER
    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.
  • KCit Load (40 meq) — OTHER
    Potassium citrate load of 40meq will be given after fasting blood has been obtained
  • Anti-resorptive agents — DRUG
    Zoledronic acid or Denosumab (as prescribed by their physician)
  • Anabolic Agents — DRUG
    Romosozumab (as prescribed by their physician)

Study Details

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)

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
25 participants (estimated)

Arms

  • Arm: Anti-resorptive agents use Group
    Patients with osteoporosis naïve to treatment will initiate treatment with anti-resorptive agents (zoledronic acid or denosumab)
  • Arm: Anabolic agents use Group
    Patients with osteoporosis naïve to treatment will initiate treatment with anabolic agents (romosozumab)

Primary Outcome Measure

Correlation of change in Urine Citrate levels to change in Potassium levels with change in bone turnover markers at 1 month after initiating treatment [ Time Frame: Baseline, 1month after initiating treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390-

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