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

Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteogenesis Imperfecta

Intervention: Zoledronic acid (Drug); Teriparatide (Drug); placebo zoledronic acid (Drug); placebo teriparatide (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Aarhus

Official(s) and/or principal investigator(s):
Bente Langdahl, MD, Principal Investigator, Affiliation: Aarhus University Hospital

Overall contact:
Bente Langdahl, Phone: 0045 7846 7678, Email: bente.langdahl@aarhus.rm.dk

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Bone Mineral Density (BMD)

Secondary outcome: Fracture risk

Eligibility

Minimum age: 22 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- clinical diagnosis of osteogenesis imperfecta

- BMD<-2. 0 or

- BMD<-1 and significant fracture within 3 years

- women postmenopausal or using accepted contraception

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

Locations and Contacts

Bente Langdahl, Phone: 0045 7846 7678, Email: bente.langdahl@aarhus.rm.dk

Department of endocrinology, Hvidovre 2650, Denmark; Recruiting
Jens-Erik B Jensen, Email: Jens-Erik.Beck.Jensen@hvh.regionh.dk
Jens-Erik B Jensen, Sub-Investigator

Department of Endocrinology M, Odense 6000, Denmark; Recruiting
Lars Folkestad, Email: lfolkestad@health.sdu.dk
Lars Folkestad, Sub-Investigator

Osteoporosis clinic; department of endocrinology and metabolism, Aarhus, Aarhus C 8000, Denmark; Recruiting
Jannie Hald, Phone: 0045 7846 7686, Email: janniehald@gmail.com
Jannie Hald, Sub-Investigator

Additional Information

Starting date: November 2012
Last updated: May 28, 2015

Page last updated: August 23, 2015

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