Study Stopped
Eli Lilly has withdrawn support to the study of teriparatide and placebo pens. The study was not able to continue as a randomized study without the supply of placebo pens.
The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta
1 other identifier
interventional
9
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2012
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2012
CompletedFirst Posted
Study publicly available on registry
September 5, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJune 25, 2021
June 1, 2021
7.7 years
August 16, 2012
June 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone Mineral Density (BMD)
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.
Three years
Secondary Outcomes (1)
Fracture risk
Three years
Study Arms (3)
Zolendronic acid, 3 yr + placebo teriparatide, 2 yr
EXPERIMENTALyearly intravenous infusion of 5mg active zoledronic acid in 3 yr
teriparatide 2 yr; active zol in 3rd yr
EXPERIMENTALdaily injection of one dose active teriparatide for two years, active zoledronic acid in year 3.
No active treatment
PLACEBO COMPARATORObservation in three years, no treatment
Interventions
antiresorptive and calcium and vitamin D
anabolic and calcium and vitamin D
Eligibility Criteria
You may qualify if:
- clinical diagnosis of osteogenesis imperfecta
- BMD\<-1.0 or
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Osteoporosis clinic; department of endocrinology and metabolism
Aarhus, Aarhus C, 8000, Denmark
Department of endocrinology
Hvidovre, 2650, Denmark
Department of Endocrinology M
Odense, 6000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bente Langdahl, MD
Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2012
First Posted
September 5, 2012
Study Start
November 1, 2012
Primary Completion
July 1, 2020
Study Completion
June 1, 2021
Last Updated
June 25, 2021
Record last verified: 2021-06