Study Complete
Sponsor ID
20160227
Study to Evaluate Romosozumab in Children and Adolescents with Osteogenesis Imperfecta
Study Details
The primary objective of this study is to evaluate the pharmacokinetics (PK) profile following multiple subcutaneous (SC) doses of romosozumab in children and adolescents with Osteogenesis Imperfecta (OI).
Protocol Summary
Primary Outcome Measures
Maximum-observed Concentration (Cmax) of Romosozumab in Serum
Timeframe: Up to Day 169
Time to Maximum-observed Concentration (tmax) of Romosozumab in Serum
Timeframe: Up to Day 169
Area Under the Curve (AUC) of Romosozumab in Serum
Timeframe: Up to Day 169
Terminal Half-life (t1/2) of Romosozumab in Serum
Timeframe: Up to Day 169
Secondary Outcome Measures
Number of Participants who Experience Treatment-emergent Adverse Events
Timeframe: Day 0 (post study drug administration) to Day 169
Number of Participants with a Clinically Significant Change from Baseline in Vital Sign Measurements
Timeframe: Baseline to Day 169
Number of Participants with Clinically Significant Changes from Baseline in Electrocardiogram (ECG) Results
Timeframe: Baseline to Day 169
Number of Participants with Clinically Significant Changes from Baseline in Physical Examination Results
Timeframe: Baseline to Day 169
Number of Participants with Clinically Significant Changes from Baseline in Safety Laboratory Tests
Timeframe: Baseline to Day 169
Number of Participants with Antiromosuzomab Antibodies
Timeframe: Up to Day 169
Percent Change from Baseline in Bone Turnover Marker: Procollagen Type 1 N-terminal Propeptide (P1NP)
Timeframe: Baseline to Day 169
Percent Change from Baseline in Bone Turnover Marker: Serum C-telopeptide (CTX)
Timeframe: Baseline to Day 169
Percent Change from Baseline in Bone Mineral Density (BMD) at the Anteroposterior Lumbar Spine
Timeframe: Baseline to Day 169
Percent Change from Baseline in Bone Mineral Content (BMC)
Timeframe: Baseline to Day 169
Percent Change from Baseline in Bone Area
Timeframe: Baseline to Day 169
Percent Change from Baseline in BMD Z-Score at Anteroposterior Lumbar Spine
Timeframe: Baseline to Day 169
Locations
Location
Gazi Universitesi Tip Fakultesi
Ankara, Turkey, 06500
Status
Recruiting
Location
Semmelweis Egyetem
Budapest, Hungary, 1094
Status
Recruiting
Location
Koc Universitesi Hastanesi
Istanbul, Turkey, 34010
Status
Recruiting
Location
Ege Universitesi Ilac Gelistirme ve Farmakokinetik Arastirma Uygulama Merkezi (ARGEFAR)
Izmir, Turkey, 35100
Status
Recruiting
Location
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, Italy, 00165
Status
Recruiting
Location
Hospital Sant Joan de Deu
Esplugues de Llobregat, Cataluña, Spain, 08950
Status
Recruiting
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