Trial · NCT01108068
Trial of Lithium Carbonate for Treatment of Osteoporosis-pseudoglioma Syndrome
NCT01108068, Not applicable, Completed, University of Maryland, Baltimore; results first posted 2018-04-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Lithium Carbonate for Treatment of Osteoporosis-pseudoglioma Syndrome. Trials, record NCT01108068. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01108068
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Lithium Carbonate for Treatment of Osteoporosis-pseudoglioma Syndrome
- NCT number
- NCT01108068
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 26 participants, actual
- Lead sponsor
- University of Maryland, Baltimore
- Conditions
- Osteoporosis Pseudoglioma
- Interventions
- Lithium
- First posted
- 2010-04-21
- Last updated
- 2019-11-04
- Results first posted
- 2018-04-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | pQCT of Lower Leg | Baseline | 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. |
| Secondary | pQCT Z-score in OPPG Participants at Baseline and 6 Months After Lithium | baseline, 6 months | 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.Z-score of pQCT variable was noted for the in two OPPG participants who received lithium and were also able to get pQCT scans. The "n" of 2 was too small to do statistical analyses. Of the 5 OPPG who were on lithium, 2 were too small for the machine (eventhough over age 4) and 1 had rods in his legs and couldn't have pQCT |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | pQCT of Lower Leg | Baseline | in OPPG, 2 were too small for pQCT machine and 2 had hardware in legs. For 2 in unaffecteds there were technical difficulties with the pQCT scanner | Z-score | MEAN |
| SECONDARY | pQCT Z-score in OPPG Participants at Baseline and 6 Months After Lithium | baseline, 6 months | Two OPPG participants who took lithium for 6 months and were able to do pQCT at baseline and 6 months. First number is baseline, 2nd number is 6 months for section modulus | Z-score | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| pQCT of Lower Leg | Lithium | Cortical Area Z-score | -2.19 | 95% Confidence Interval -3.0 to -0.14 | Z-score |
| pQCT of Lower Leg | Unaffected Controls | Cortical Area Z-score | 0.04 | 95% Confidence Interval -0.51 to 0.95 | Z-score |
| pQCT of Lower Leg | Lithium | Periosteal circum. Z | -2.09 | 95% Confidence Interval -3.8 to 0 | Z-score |
| pQCT of Lower Leg | Unaffected Controls | Periosteal circum. Z | -0.30 | 95% Confidence Interval -2.35 to 1.17 | Z-score |
| pQCT Z-score in OPPG Participants at Baseline and 6 Months After Lithium | OPPG Rx With Lithium | Baseline Z-score SM | -4.96 | Standard Deviation 0.12 | Z-score |
| pQCT Z-score in OPPG Participants at Baseline and 6 Months After Lithium | OPPG Rx With Lithium | 6 mo Z-score SM | -4.93 | Standard Deviation 0.64 | Z-score |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lithium | 10 | |
| Overall Study | STARTED | Unaffected Controls | 16 | |
| Overall Study | COMPLETED | Lithium | 4 | |
| Overall Study | COMPLETED | Unaffected Controls | 16 | |
| Overall Study | NOT COMPLETED | Lithium | 6 | |
| Overall Study | NOT COMPLETED | Unaffected Controls | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | elevated liver function test | Hepatobiliary disorders | Lithium | 1 | 10 | 1 |
| other | elevated liver function test | Hepatobiliary disorders | Unaffected Controls | 0 | 16 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lithium | 0 | 10 |
| Total, all-cause mortality | Unaffected Controls | 0 | 16 |
| Total, other adverse events | Lithium | 1 | 10 |
| Total, other adverse events | Unaffected Controls | 0 | 16 |
| Total, serious adverse events | Lithium | 0 | 10 |
| Total, serious adverse events | Unaffected Controls | 0 | 16 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lithium vs Unaffected Controls: deaths from any cause | Trial comparisons |
| Lithium vs Unaffected Controls: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01108068
GET https://conductscience.org/api/trials/v1/NCT01108068/registered