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

Study Overview
=================
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.

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

Conditions
-----------------
Osteogenesis Imperfecta

Intervention / Treatment
-----------------
* Drug: Zoledronic acid
* Drug: Teriparatide
* Other: No active treatment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zolendronic acid, 3 yr + placebo teriparatide, 2 yr<br>yearly intravenous infusion of 5mg active zoledronic acid in 3 yr | Drug: Zoledronic acid<br>* antiresorptive and calcium and vitamin D<br>* Other names: Aclasta;|
| Experimental: teriparatide 2 yr; active zol in 3rd yr<br>daily injection of one dose active teriparatide for two years, active zoledronic acid in year 3. | Drug: Zoledronic acid<br>* antiresorptive and calcium and vitamin D<br>* Other names: Aclasta;Drug: Teriparatide<br>* anabolic and calcium and vitamin D<br>* Other names: Forsteo;|
| Placebo Comparator: No active treatment<br>Observation in three years, no treatment | Other: No active treatment<br>* Calcium and vitamin D<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult, Drug therapy