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

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2014 by University of Aarhus

Sponsor:

Information provided by (Responsible Party):

University of Aarhus

ClinicalTrials.gov Identifier:

NCT01679080

First received: August 16, 2012

Last updated: August 12, 2014

Last verified: August 2014

History of Changes

Purpose

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	Intervention	Phase
Osteogenesis Imperfecta	Drug: Zoledronic acid Drug: Teriparatide Drug: placebo zoledronic acid Drug: placebo teriparatide	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta

Resource links provided by NLM:

Genetics Home Reference related topics: mucopolysaccharidosis type IV osteogenesis imperfecta

MedlinePlus related topics: Osteogenesis Imperfecta

Drug Information available for: Teriparatide Teriparatide acetate Zoledronic acid

Genetic and Rare Diseases Information Center resources: Osteogenesis Imperfecta Osteogenesis Imperfecta Type 2B

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Bone Mineral Density (BMD) [ Time Frame: Three years ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Three years ] [ Designated as safety issue: No ]
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.


Estimated Enrollment:	80
Study Start Date:	November 2012
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Zolendronic acid + placebo teriparatide yearly intravenous infusion of 5mg and daily injection of one dose teriparatide	Drug: Zoledronic acid antiresorptive Other Names: zolendronate Aclasta Drug: placebo teriparatide
Experimental: teriparatide + placebo zoledronic acid yearly infusion of placebo zoledronic acid (isotonic sodium chloride)and daily injection of one dose active teriparatide	Drug: Teriparatide anabolic Other Names: PTH Forsteo Drug: placebo zoledronic acid
Placebo Comparator: pcb zoledronic acid + pcb teriparatide yearly infusion of placebo zoledronic acid and daily injection of placebo teriparatide	Drug: placebo zoledronic acid Drug: placebo teriparatide

Eligibility


Ages Eligible for Study:	22 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

clinical diagnosis of osteogenesis imperfecta
BMD<-2.0 or
BMD<-1 and significant fracture within 3 years
women postmenopausal or using accepted contraception

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679080

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	Not yet 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	Not yet 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

No publications provided


Responsible Party:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT01679080 History of Changes
Other Study ID Numbers:	TreatOI
Study First Received:	August 16, 2012
Last Updated:	August 12, 2014
Health Authority:	Denmark: Danish Health and Medicines Authority

Keywords provided by University of Aarhus:


Drug therapy Adult

Additional relevant MeSH terms:


Osteogenesis Imperfecta Bone Diseases Bone Diseases, Developmental Collagen Diseases Connective Tissue Diseases Genetic Diseases, Inborn Musculoskeletal Diseases	Osteochondrodysplasias Diphosphonates Teriparatide Zoledronic acid Bone Density Conservation Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015

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