CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
Lithiumdrug
Likely dose
Lithium 2.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01108068
NCT01108068N/ACompleted

Trial of Lithium Carbonate for Treatment of Osteoporosis Pseudoglioma Syndrome

University of Maryland, Baltimore·interventional·Posted Apr 21, 2010·Updated Nov 4, 2019

In Brief

A clinical study evaluating Lithium for Osteoporosis Pseudoglioma. Completed, enrolled 26 participants across 1 site.

Detailed Summary

This was a pilot study of 10 patients with Osteoporosis-pseudoglioma syndrome (OPPG) from the Old Order Mennonite community and 16 controls, who did not have OPPG. Five of the 10 OPPG patient elected to participate in the Lithium trial and 5 participated only in baseline data (labs, pQCT). The 5 with OPPG who were given lithium for 6 months had both dual energy xray absorptiometry (DXA), peripheral quantitative computerized tomography (pQCT) and lab assessment at baseline and 6 months. Studies in the mouse model of OPPG showed that lithium normalized their bone strength. Controls (n=16) were recruited from the Old Order Mennonite community, to minimize the effects of environmental and lifestyle factors. The controls were not be given lithium. The age range of participants was 4-64 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 21, 2010
Enrollment StartJul 1, 2010
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 16.2 years ago

Interventions

Lithiumdrug

lithium will be given for 6 months to patients with OPPG, starting at a low dose of 2.5 mg/kg daily, gradually increasing until a lithium blood level of 0.3-0.6 ng/dl is achieved.