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

Primary Purpose

Osteogenesis Imperfecta

Status
Terminated
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Zoledronic acid
Teriparatide
No active treatment
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteogenesis Imperfecta focused on measuring Drug therapy, Adult

Eligibility Criteria

22 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Osteoporosis clinic; department of endocrinology and metabolism
  • Department of endocrinology
  • Department of Endocrinology M

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Zolendronic acid, 3 yr + placebo teriparatide, 2 yr

teriparatide 2 yr; active zol in 3rd yr

No active treatment

Arm Description

yearly intravenous infusion of 5mg active zoledronic acid in 3 yr

daily injection of one dose active teriparatide for two years, active zoledronic acid in year 3.

Observation in three years, no treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Fracture risk
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.

Full Information

First Posted
August 16, 2012
Last Updated
June 22, 2021
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01679080
Brief Title
The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta
Official Title
The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteogenesis Imperfecta
Keywords
Drug therapy, Adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zolendronic acid, 3 yr + placebo teriparatide, 2 yr
Arm Type
Experimental
Arm Description
yearly intravenous infusion of 5mg active zoledronic acid in 3 yr
Arm Title
teriparatide 2 yr; active zol in 3rd yr
Arm Type
Experimental
Arm Description
daily injection of one dose active teriparatide for two years, active zoledronic acid in year 3.
Arm Title
No active treatment
Arm Type
Placebo Comparator
Arm Description
Observation in three years, no treatment
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
zolendronate, Aclasta
Intervention Description
antiresorptive and calcium and vitamin D
Intervention Type
Drug
Intervention Name(s)
Teriparatide
Other Intervention Name(s)
PTH, Forsteo
Intervention Description
anabolic and calcium and vitamin D
Intervention Type
Other
Intervention Name(s)
No active treatment
Intervention Description
Calcium and vitamin D
Primary Outcome Measure Information:
Title
Bone Mineral Density (BMD)
Description
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.
Time Frame
Three years
Secondary Outcome Measure Information:
Title
Fracture risk
Description
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.
Time Frame
Three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bente Langdahl, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osteoporosis clinic; department of endocrinology and metabolism
City
Aarhus
State/Province
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Department of endocrinology
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Department of Endocrinology M
City
Odense
ZIP/Postal Code
6000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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