Skip to content

Trial · Interventional

CompletedPhase 4Results postedRegistry data

Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta

Short name OI

NCTNCT00131469 (opens ClinicalTrials.gov in a new tab)Other idIBMD-OIOther idUL1RR024140
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
79 participants (actual)
Sponsor
Oregon Health and Science University · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Jun 2005
Primary completion
Jan 2011
Completion
Jan 2011
First posted
18 Aug 2005 (estimated)
Last update posted
24 Apr 2019
Conditions
Osteogenesis Imperfecta

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200820102012
  1. Ph 4

    OI

    NCT00131469

    Jun 2005 to Jan 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • Teriparatide (FORTEO)Drug
  • PlacebosDrug

Arms2

  • Active comparator

    Teriparatide (FORTEO)

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

  • Placebo comparator

    Placebo

    Daily SQ placebo for 18 months

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Spine Bone Mineral Density (BMD)

    Time frame · baseline and 18 months

    Registry description

    bone density by dual energy xray absorptiometry

Secondary outcomes(1)

  1. Total Hip BMD

    Time frame · baseline and 18 months

    Registry description

    bone density by dual energy xray absorptiometry

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· baseline and 18 months

Spine Bone Mineral Density (BMD)

GroupValue (percentage of change in g/cm2)Spread
Teriparatide (FORTEO)6.11.5
Placebo2.81.3
Secondary and other outcome results(1)
Secondary outcomeMean· baseline and 18 months

Total Hip BMD

GroupValue (percentage of change in g/cm2)Spread
Teriparatide (FORTEO)2.62
Placebo-2.41.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Teriparatide (FORTEO)Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months Teriparatide (FORTEO): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily0 / 380 / 380 / 38
PlaceboDaily SQ placebo for 18 months Placebos1 / 400 / 400 / 40

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2014

10 results

Evaluation of teriparatide treatment in adults with osteogenesis imperfecta.

Orwoll et al. 2014The Journal of clinical investigationcited by 145

PMID 24463451PMC3904621DOI 10.1172/jci71101PUB-24463451

Rights unknown10 results
Source linkSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * Open epiphyses. * History of external beam radiation to the skeleton. * Pagets disease. * Bone metastases or skeletal malignancies. * Total lifetime exposure to any antiresorptive medication \< 90 days (Primary Inclusion). * Treatment with any antiresorptive medication 12 months proceeding enrollment - (Secondary Inclusion). * Women with OI who are pregnant or unwilling to use 1 form of contraception. * Vitamin D insufficiency (25-hydroxyvitamin D \<15ng/ml)

PepBank is a research reference. Talk to a doctor before you use any peptide.