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NCT01108068 · ClinicalTrials.gov registry record · NA

Trial of Lithium Carbonate for Treatment of Osteoporosis-pseudoglioma Syndrome

A NA study, sponsored by University of Maryland, Baltimore.

Completed
Registry status
NA
Development phase
26
Enrollment target

NCT01108068: Completed NA study, sponsored by University of Maryland, Baltimore.

NCT01108068 is a NA study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01108068, a NA study, has completed, sponsored by University of Maryland, Baltimore.

COMPLETED
Registry status
NA
Development phase
26 participants
Enrollment target

Study 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.

Primary Outcome

pQCT will be done at baseline for all OPPG participants and unaffecteds. The Z-score indicates the number of standard deviations away from the mean of age matched controls. A Z-score of 0 is equal to the mean, with negative numbers indicating values lower than the mean and positive values higher. A positive change in Z-score indicates a favorable outcome.

Interventions

  • DRUG Lithium

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2010-07
Est. Completion 2014-07
Phase NA
University of Maryland, Baltimore

560 total trials

What the finished NCT01108068 record still lists

NCT01108068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Lithium is the first listed.

NCT01108068 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01108068 about?

NCT01108068 is a clinical study titled "Trial of Lithium Carbonate for Treatment of Osteoporosis-pseudoglioma Syndrome". 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 wit...

What is the current status of trial NCT01108068?

This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2010-07. Estimated completion is 2014-07.

What interventions are being tested in trial NCT01108068?

The interventions under investigation include: Lithium (DRUG).

Who is sponsoring clinical trial NCT01108068?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01108068's enrollment target sits among peer trials

26 1710th of 2000 higher than 289 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01108068, the US trial registry maintained by the National Library of Medicine. NCT01108068 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.