NCT00131469

Brief Summary

The purpose of this study is to determine the effectiveness of teriparatide (FORTEO), which is human parathyroid hormone 1-34, for increasing bone mass and improving bone structure in adults affected with Osteogenesis Imperfecta (OI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2005

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
8.3 years until next milestone

Results Posted

Study results publicly available

April 24, 2019

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

5.6 years

First QC Date

August 16, 2005

Results QC Date

March 14, 2019

Last Update Submit

April 4, 2019

Conditions

Osteogenesis Imperfecta

Keywords

Osteogenesis ImperfectaBrittle Bone DiseaseFragility Fractures

Outcome Measures

Primary Outcomes (1)

  • Spine Bone Mineral Density (BMD)

    bone density by dual energy xray absorptiometry

    baseline and 18 months

Secondary Outcomes (1)

  • Total Hip BMD

    baseline and 18 months

Study Arms (2)

Teriparatide (FORTEO)

ACTIVE COMPARATOR

Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months

Drug: Teriparatide (FORTEO)

Placebo

PLACEBO COMPARATOR

Daily SQ placebo for 18 months

Drug: Placebos

Interventions

Teriparatide (FORTEO)DRUG

Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily

Also known as: FORTEO
Teriparatide (FORTEO)
PlacebosDRUG
Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous established diagnosis of Osteogenesis Imperfecta AND
  • \> 2 previous adult fractures, AND/OR
  • BMD at lumbar spine, femoral neck or total hip T score \< -2.0

You may not qualify if:

  • Open epiphyses.
  • History of external beam radiation to the skeleton.
  • Pagets disease.
  • Bone metastases or skeletal malignancies.
  • Women with OI who are pregnant or unwilling to use 1 form of contraception.
  • Vitamin D insufficiency (25-hydroxyvitamin D \<15ng/ml)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

Baylor College of Medicine, Department of Molecular and Human Gentics

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Orwoll ES, Shapiro J, Veith S, Wang Y, Lapidus J, Vanek C, Reeder JL, Keaveny TM, Lee DC, Mullins MA, Nagamani SC, Lee B. Evaluation of teriparatide treatment in adults with osteogenesis imperfecta. J Clin Invest. 2014 Feb;124(2):491-8. doi: 10.1172/JCI71101. Epub 2014 Jan 27.

    PMID: 24463451DERIVED

Related Links

MeSH Terms

Conditions

Osteogenesis Imperfecta

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

OsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Eric Orwoll
Organization
OHSU
orwoll@ohsu.edu
15034940225

Study Officials

  • Eric S Orwoll, M.D.

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

  • Jay Shapiro, M.D.

    Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    PRINCIPAL INVESTIGATOR

  • Brendan Lee, M.D., PhD

    Balor College of Medicine

    PRINCIPAL INVESTIGATOR

  • Sandra Veith, CRA

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Of Medicine

Study Record Dates

First Submitted

August 16, 2005

First Posted

August 18, 2005

Study Start

June 1, 2005

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

April 24, 2019

Results First Posted

April 24, 2019

Record last verified: 2019-04

Locations

US(3)