Status:
COMPLETED
Translational Therapy in Patients With Osteogenesis Imperfecta - A Pilot Trial on Treatment With the Rankl-Antibody Denosumab
Lead Sponsor:
University of Cologne
Conditions:
Osteogenesis Imperfecta
Eligibility:
All Genders
5-11 years
Phase:
PHASE2
Brief Summary
Pilot study to assess the efficacy of a therapy with the RANKL-antibody denosumab in children 5-10 years of age with mutation in COL1A1 or COL1A2 leading to Osteogenesis imperfecta. Efficacy will be a...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male or female subjects between 5 years and 10 years of age with molecular proven Osteogenesis imperfecta (COL1A1/A2 mutation)
- Subjects must have been treated for a minimum of 2 years with 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.
Exclusion
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01799798
Start Date
February 1 2013
End Date
January 1 2015
Last Update
January 27 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Cologne, Childrens Hospital, Cologne, Germany
Cologne, North Rhine-Westphalia, Germany, 50924