DRKS00004521
Completed
Phase 2
Translational therapy in patients with osteogenesis imperfecta - a pilot trial on treatment with the RANKL-antibody Denosumab - OI-AK
Klinik und Poliklinik für Kinder- und Jugendmedizin0 sites10 target enrollmentFebruary 15, 2013
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Q78.0
- Sponsor
- Klinik und Poliklinik für Kinder- und Jugendmedizin
- Enrollment
- 10
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects between 5 years and 10 years of age with molecular proven Osteogenesis imperfecta (COL1A1/2 mutation)
- •Subjects must have been treated for a minimum of 2 years with i.v. bisphosphonates prior to study entry
Exclusion Criteria
- •Hypocalcemia (\<1\.03 mmol/l ionized Calcium)
- •Subjects with reduced renal function (estimated GFR (Schwartz formula) \<30ml/min/1\.73m2\)
- •Any other abnormal finding such as physical examination or laboratory evaluation, in the opinion of the investigator that is indicative of a disease that would compromise the safety of the patient when getting Denosumab s.c.
Outcomes
Primary Outcomes
Not specified
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