The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta

Osteogenesis Imperfecta Clinical Trial

Official title:

The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01679080
• Other study ID #: TreatOI
• Status: Terminated
• Phase: Phase 2
• Start date: November 2012
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Osteogenesis imperfecta (OI) is an inherited disease of the connective tissue. Symptoms are fractures, growth retardation, blue sclera, bad teeth, impaired hearing a.o. The aim of the present study is to investigate the effect of treatment of adult OI patients with bisphosphonate (zoledronic acid), parathyroid hormone (PTH) or placebo on bone mass, fracture risk and quality of life. The investigators will therefore conduct a double blind, placebo controlled trial, taking genotype and previous antiresorptive therapy into account.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 1, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 70 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of osteogenesis imperfecta
• BMD<-1.0 or

Exclusion Criteria:

• creatinine clearance <30mL/min
• treatment with glucocorticoids > 5mg daily during the last 3 months
• metabolic bone disease or vitamin d deficiency
• liver or kidney disease
• contradictions to zoledronic acid or teriparatide
• increased baseline risk of osteosarcoma

Related Conditions & MeSH terms

• Osteogenesis Imperfecta

Intervention

Drug:
• Zoledronic acid
antiresorptive and calcium and vitamin D
• Teriparatide
anabolic and calcium and vitamin D

Other:
• No active treatment
Calcium and vitamin D

Locations

Country	Name	City	State
Denmark	Osteoporosis clinic; department of endocrinology and metabolism	Aarhus	Aarhus C
Denmark	Department of endocrinology	Hvidovre
Denmark	Department of Endocrinology M	Odense

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density (BMD)	Dual-energy X-ray absorptiometry scans are performed at the lumbar spine, hip and whole body twice yearly. The value of the lumbar BMD is the primary outcome.	Three years
Secondary	Fracture risk	Participants are asked to report fractures throughout the study. Medical examination yearly with a focus on possible new fractures. Columnar x-ray before and after the study investigate new fractures.	Three years