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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Osteogenesis Imperfecta	Drug: Zoledronic acid; Drug: Teriparatide; Other: No active treatment	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	80 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta
Study Start Date :	November 2012
Estimated Primary Completion Date :	December 2021
Estimated Study Completion Date :	December 2021

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Bone Mineral Density (BMD) [ Time Frame: Three years ]
   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 :

1. Fracture risk [ Time Frame: Three years ]
   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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	22 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT01679080 History of Changes
Other Study ID Numbers:	TreatOI
First Posted:	September 5, 2012
Last Update Posted:	January 9, 2017
Last Verified:	January 2016

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