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:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT04009733
Eligibility Criteria:
Inclusion Criteria:
Control population:
* Male or female
* 18 years old and over
* Be part of cohorts STRAMBO, OFELY or MODAM
Patients with OI:
* Male or female ≥18 years old
* Have COL1A1 or COL1A2 mutation
* Have a diagnosis of type 1 or 3 from Silence classification made by a rheumatologist expert in bone pathologies
Exclusion Criteria:
* Refusal to participate in the study
* Have received glucocorticoid treatment for more than 3 months
* Have received anti-osteoporotic treatment for less than 1 year ago
* Have Chronic inflammatory rheumatism
* Have an uncontrolled hypo/hyper thyroidism ou hypo/hyper parathyroidism
* Have cancer or bone metastases (current or in the past two years)
* Have benign bone tumors or Paget's disease
* Have malabsorptive disease (Celiac disease, Whipple's disease, intestinal bypass, short bowel syndrome) and inflammatory bowel disease
* Pregnant or lactating women
* Have psychiatric disorders seriously hindering understanding
* Have difficulties in oral understanding of French language
* Not a beneficiary of french social security
* Patients protected by law
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04009733
Study Brief:
Protocol Section:
NCT04009733