CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 33 enrolled
Drug / intervention
Paricalcitol +1 moredrug
Likely dose
Paricalcitol 2 capsules once daily, with dose titration as neededAI-extracted
Key inclusion· 5
  • ✓Confirmed diagnosis of X-linked hypophosphatemic rickets (XLH)
  • ✓Fasting serum calcium ≤10.7 mg/dL
  • ✓Fasting PTH 40–120 nleq/ml (mid-molecule assay; upper normal limit 25 nleq/ml)
  • ✓Stable dose of standard XLH therapy for ≥2 months before enrollment
Key exclusion· 4
  • ✕Kidney disease: eGFR <60 cc/min or serum creatinine >1.5 mg/dL
  • ✕Serum 25-hydroxy vitamin D <20 ng/ml (unless supplemented for 3 months and rescreened)
  • ✕Use of medications affecting skeletal metabolism (glucocorticoids, anticonvulsants)
  • ✕Unable to comply with protocol and follow-up visits

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

Search/NCT00417612
NCT00417612Phase 3Completed
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The Role of Parathyroid Hormone in the Pathogenesis of Skeletal Disease in X-linked Hypophosphatemic Rickets (XLH)

Yale University·interventional·Posted Jan 1, 2007·Updated Mar 17, 2020

In Brief

A Phase 3 clinical trial evaluating Paricalcitol and Placebo for Hypophosphatemia, Familial and Hyperparathyroidism. Completed, enrolled 33 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the effectiveness of paricalcitol, a form of synthetic vitamin D, in lowering parathyroid hormone (PTH) levels and reducing disease symptoms in children and adults with X-linked hypophosphatemic (XLH) rickets.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypophosphatemia, Familial, Hyperparathyroidism
CountriesUnited States
CollaboratorsNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 1, 2007
Enrollment StartJan 1, 2007
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 19.5 years ago

Interventions

Paricalcitoldrug

Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits.

Placeboother

Placebo sugar pill