Trial of Lithium Carbonate for Treatment of Osteoporosis-pseudoglioma Syndrome

Completed · Not applicable

Conditions studied: Osteoporosis Pseudoglioma

In brief

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.

Key facts

Study ID

NCT01108068

Run by

University of Maryland, Baltimore

People needed

26

Starts

2010-07-01

Expected to finish

2014-07-01

Last updated by the study team

2019-11-04

Who can join

Age: 4 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 4 years or greater
• Diagnosed with osteoporosis pseudoglioma syndrome (OPPG) or a first degree relative of someone with OPPG. For diagnosis of OPPG, one of the following is required: (1) congenital blindness in a child born into a family with known OPPG where at least one affected family member has had an LRP5 mutation demonstrated or (2) a child with no known family members with OPPG who has congenital blindness, DXA Z-score < -2.0 and mutation in LRP5 documented
• No contraindications to lithium carbonate
• For women of child bearing age, willing to undergo urine pregnancy test

You may not qualify if…

• Age under 4 years
• Not diagnosed with osteoporosis pseudoglioma (OPPG) syndrome or a first degree relative of someone with OPPG, or a member of the Old Order Mennonite community
• Pregnant
• For women of childbearing age, not willing to undergo urine pregnancy test
• Contraindication to Lithium (serum creatinine > 1.3, known cardiovascular disease [history of myocardial infarction, heart failure], currently on diuretic or ACE inhibitor)
• Glomerular filtration rate below 80 cc/min

Where it is running

• University of Maryland Amish Research Clinic — Lancaster, Pennsylvania, United States

Full record on ClinicalTrials.gov

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