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

Phase 1

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-BE

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

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) no
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

Primary Outcome Measures

Name	Time	Method
Main Objective: Assessment of safety, tolerability, pharmacodynamics, and bone mass density.;Secondary Objective: Assessment of pharmacokinetic profile, total/free sclerostin in serum, and immunogenicity.;Primary end point(s): Safety, tolerability, biomarkers and bone mineral density;Timepoint(s) of evaluation of this end point: Over 21 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Multiple endpoints will be assessed in this trial, related to efficacy, pharmacodynamics, safety, health related quality of life, pharmacokinetics, pharmacogenetics.;Timepoint(s) of evaluation of this end point: Over 21 weeks