Safety and pharmacokinetics clinical of BPS804 in adult patients with osteogenesis imperfecta

• Conditions: Patients with previously established diagnosis of osteogenesis imperfecta (OI). OI is a rare genetic disorder of the connective tissue characterized by bone fragility and reduced bone mass. OI comprises a group of inherited disorders which primarily, but not always, arise from mutations in the genes encoding type I collagen.; MedDRA version: 14.1Level: PTClassification code 10031243Term: Osteogenesis imperfectaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-001465-41-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-09
• Last Update Posted: 14 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Osteogenesis imperfecta
Two or more previous fractures
Bone mineral density Z-score of = -1.0 and > -4.0
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 11
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

Open epiphyses
Fracture within last 2 weeks
Treatment with bisphosphonates/teriparatide (last 6 months)
Surgery within last year

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified