Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT01108068
Eligibility Criteria:
Eligibility Criteria
Inclusion Criteria
* 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
Exclusion Criteria
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
64 Years
Study:
NCT01108068
Study Brief:
Protocol Section:
NCT01108068