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

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ClinicalTrials.gov Identifier: NCT01679080
Recruitment Status : Recruiting
First Posted : September 5, 2012
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Osteogenesis Imperfecta Drug: Zoledronic acid Drug: Teriparatide Other: No active treatment Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta
Study Start Date : November 2012
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Arms and Interventions

Arm Intervention/treatment
Experimental: Zolendronic acid, 3 yr + placebo teriparatide, 2 yr
yearly intravenous infusion of 5mg active zoledronic acid in 3 yr
Drug: Zoledronic acid
antiresorptive and calcium and vitamin D
Other Names:
  • zolendronate
  • Aclasta
Experimental: teriparatide 2 yr; active zol in 3rd yr
daily injection of one dose active teriparatide for two years, active zoledronic acid in year 3.
Drug: Zoledronic acid
antiresorptive and calcium and vitamin D
Other Names:
  • zolendronate
  • Aclasta
Drug: Teriparatide
anabolic and calcium and vitamin D
Other Names:
  • PTH
  • Forsteo
Placebo Comparator: No active treatment
Observation in three years, no treatment
Other: No active treatment
Calcium and vitamin D


Outcome Measures

Primary Outcome Measures :
  1. Bone Mineral Density (BMD) [ Time Frame: Three years ]
    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.


Secondary Outcome Measures :
  1. Fracture risk [ Time Frame: Three years ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Recruiting
Aarhus, Aarhus C, Denmark, 8000
Contact: Jannie Hald    0045 7846 7686    janniehald@gmail.com   
Sub-Investigator: Jannie Hald         
Department of endocrinology 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 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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01679080     History of Changes
Other Study ID Numbers: TreatOI
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2016

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
Diphosphonates
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs