Study Complete
Sponsor ID
20160227

Study to Evaluate Romosozumab in Children and Adolescents with Osteogenesis Imperfecta

Sponsor ID
20160227
Clinicaltrials.gov ID
NCT04545554
EUCTIS ID
N/A
EudraCT ID
2017-004972-74

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).

Additional Study Details

Phase
Phase 1
Product
romosozumab
Type
Interventional
Masking
None (Open Label)
Enrollment
25
Additional Study Details

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
Status
Contact Us
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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