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

This study is not yet open for participant recruitment.
Verified October 2012 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01679080
First received: August 16, 2012
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteogenesis Imperfecta
 Drug: Zoledronic acid
Drug: Teriparatide
Drug: placebo zoledronic acid
Drug: placebo teriparatide
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: Three years ] [ Designated as safety issue: Yes ]
    DXA scans are performed at the lumbar spine, hip and whole body twice yearly. The value of the lumbar BMD is the primary outcome.


Secondary Outcome Measures:
  • Fracture risk [ Time Frame: Three years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: November 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zolendronic acid + placebo teriparatide
yearly intravenous infusion of 5mg and daily injection of one dose teriparatide
 Drug: Zoledronic acid
antiresorptive
Other Names:
  • zolendronate
  • Aclasta
Drug: placebo teriparatide
Experimental: teriparatide + placebo zoledronic acid
yearly infusion of placebo zoledronic acid (isotonic sodium chloride)and daily injection of one dose active teriparatide
 Drug: Teriparatide
anabolic
Other Names:
  • PTH
  • Forsteo
Drug: placebo zoledronic acid
Placebo Comparator: pcb zoledronic acid + pcb teriparatide
yearly infusion of placebo zoledronic acid and daily injection of placebo teriparatide
 Drug: placebo zoledronic acid Drug: placebo teriparatide

  Eligibility

Ages Eligible for Study:   22 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679080

Contacts
Contact: Bente Langdahl 0045 7846 7678 bente.langdahl@aarhus.rm.dk
Contact: Jannie Hald 0045 7846 7681 janniehald@gmail.com

Locations
Denmark
Osteoporosis clinic; department of endocrinology and metabolism Not yet recruiting
Aarhus, Aarhus C, Denmark, 8000
Contact: Jannie Hald     0045 7846 7686     janniehald@gmail.com    
Sub-Investigator: Jannie Hald            
Department of endocrinology Not yet recruiting
Hvidovre, Denmark, 2650
Contact: Jens-Erik B Jensen         Jens-Erik.Beck.Jensen@hvh.regionh.dk    
Sub-Investigator: Jens-Erik B Jensen            
Department of Endocrinology M Not yet recruiting
Odense, Denmark, 6000
Contact: Lars Folkestad         lfolkestad@health.sdu.dk    
Sub-Investigator: Lars Folkestad            
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Bente Langdahl, MD Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01679080     History of Changes
Other Study ID Numbers: TreatOI
Study First Received: August 16, 2012
Last Updated: October 29, 2012
Health Authority: Denmark: Danish Health and Medicines Authority

Keywords provided by University of Aarhus:
Drug therapy
Adult

Additional relevant MeSH terms:
Osteogenesis Imperfecta
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Collagen Diseases
 Connective Tissue Diseases
Zoledronic acid
Teriparatide
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013