The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta
NCT ID: NCT01679080
Last Updated: 2021-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
9 participants
INTERVENTIONAL
2012-11-30
2021-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The investigators will therefore conduct a double blind, placebo controlled trial, taking genotype and previous antiresorptive therapy into account.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic Acid
NCT03735537
Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women
NCT00927186
Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI
NCT02352753
Effect of Teriparatide on Fracture Healing in Patients With Incomplete Atypical Femur Fractures
NCT01896011
The Impact of Parathyroid Hormone (PTH) on Craniofacial Osseous Regeneration in Bone
NCT01279187
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Zolendronic acid, 3 yr + placebo teriparatide, 2 yr
yearly intravenous infusion of 5mg active zoledronic acid in 3 yr
Zoledronic acid
antiresorptive and calcium and vitamin D
teriparatide 2 yr; active zol in 3rd yr
daily injection of one dose active teriparatide for two years, active zoledronic acid in year 3.
Zoledronic acid
antiresorptive and calcium and vitamin D
Teriparatide
anabolic and calcium and vitamin D
No active treatment
Observation in three years, no treatment
No active treatment
Calcium and vitamin D
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Zoledronic acid
antiresorptive and calcium and vitamin D
Teriparatide
anabolic and calcium and vitamin D
No active treatment
Calcium and vitamin D
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMD\<-1.0 or
Exclusion Criteria
* 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
22 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Aarhus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bente Langdahl, MD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Osteoporosis clinic; department of endocrinology and metabolism
Aarhus, Aarhus C, Denmark
Department of endocrinology
Hvidovre, , Denmark
Department of Endocrinology M
Odense, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TreatOI
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.