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Trial of Lithium Carbonate for Treatment of Osteoporosis-pseudoglioma Syndrome

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ClinicalTrials.gov Identifier: NCT01108068
Recruitment Status : Completed
First Posted : April 21, 2010
Results First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Elizabeth Streeten, University of Maryland

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Osteoporosis Pseudoglioma
Intervention: Drug: Lithium

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from patients with OPPG being treated by Dr Streeten and their unaffected family members

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lithium

patients with OPPG will be treated with lithium for 6 months

Lithium: 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.

Unaffected Controls Family members of patients with OPPG will have DXA and pQCT to compare to OPPG patients. These unaffected participants will not receive lithium.

Participant Flow:   Overall Study
    Lithium   Unaffected Controls
STARTED   10   16 
COMPLETED   4 [1]   16 
NOT COMPLETED   6   0 
5 not started, 1 stop due to side effect                6                0 
[1] Only 5 individuals were recruited into the Lithium treatment arm



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants were from the Old Order Mennonite community from PA

Reporting Groups
  Description
Lithium

patients with OPPG will be treated with lithium for 6 months

Lithium: 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.

Unaffected Controls Family members of patients with OPPG will have DXA and pQCT to compare to OPPG patients. These unaffected participants will not receive lithium.
Total Total of all reporting groups

Baseline Measures
   Lithium   Unaffected Controls   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   16   26 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      7  70.0%      8  50.0%      15  57.7% 
Between 18 and 65 years      3  30.0%      8  50.0%      11  42.3% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 13.4  (2.5)   21.8  (16.5)   18.8  (14.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  40.0%      11  68.8%      15  57.7% 
Male      6  60.0%      5  31.3%      11  42.3% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Causasian   10   16   26 
Region of Enrollment 
[Units: Participants]
     
United States   10   16   26 


  Outcome Measures

1.  Primary:   pQCT of Lower Leg   [ Time Frame: Baseline ]

2.  Secondary:   pQCT Z-score in OPPG Participants at Baseline and 6 Months After Lithium   [ Time Frame: baseline, 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Elizabeth Streeten, MD
Organization: University of Maryland School of Medicine
phone: 410-328-3335
e-mail: estreete@som.umaryland.edu


Publications:

Responsible Party: Elizabeth Streeten, University of Maryland
ClinicalTrials.gov Identifier: NCT01108068     History of Changes
Other Study ID Numbers: HP-00040536
First Submitted: April 20, 2010
First Posted: April 21, 2010
Results First Submitted: April 21, 2017
Results First Posted: April 27, 2018
Last Update Posted: April 27, 2018