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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01679080
First received: August 16, 2012
Last updated: May 27, 2016
Last verified: May 2016
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 (BMD) [ Time Frame: Three years ] [ Designated as safety issue: Yes ]
    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:
  • 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 2021
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zolendronic acid, 3 yr + placebo teriparatide, 2 yr
yearly intravenous infusion of 5mg active zoledronic acid in 3 yr and daily injection of one dose placebo teriparatide in two years.
 Drug: Zoledronic acid
antiresorptive
Other Names:
  • zolendronate
  • Aclasta
Drug: placebo teriparatide
Experimental: teriparatide, 2 yr + placebo zoledronic acid,act zol in 3rd yr
yearly infusion of placebo zoledronic acid (isotonic sodium chloride) and daily injection of one dose active teriparatide for two years, active zoledronic acid in third yr.
 Drug: Zoledronic acid
antiresorptive
Other Names:
  • zolendronate
  • Aclasta
Drug: Teriparatide
anabolic
Other Names:
  • PTH
  • Forsteo
Drug: placebo zoledronic acid
Placebo Comparator: pcb zoledronic acid, 3 yr + pcb teriparatide, 2 yr
yearly infusion of placebo zoledronic acid in three years and daily injection of placebo teriparatide in two years.
 Drug: placebo zoledronic acid Drug: placebo teriparatide

  Eligibility
Ages Eligible for Study:   22 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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 
Study First Received: August 16, 2012
Last Updated: May 27, 2016
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
Diphosphonates
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016