The Effect of Treatment with PTH and Zoledronic acid in Patients with Osteogenesis Imperfecta

Phase 1

• Conditions: Osteogenesis imperfecta; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-002811-27-DK
• Lead Sponsor: Bente Langdahl, consultant, ass. professor, PhD, DMSc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-04
• Last Update Posted: 18 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Inklusion criterias
•Patients with OI type I and IV
•Age 22 - 70 years
•Informed consent
oLow BMD (T-score =/< -1.0) or =/<-1
•For women: = 1 year postmenopausal

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 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exklusion criterias
•Creatinine clearance < 30 mL/min
•Previous treatment with PTH. Previous treatment with antiresorptives is not an exclusion criteria, but will be used for stratification of the patients
•Treatment with glucocorticoids = 5mg daily during the last 3 months.
•Metabolic bone disease or vitamin D deficiency.
•Liver- or kidney disease
•Existing contra indications for treatment with zoledronic acid or PTH

Study & Design

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