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Trial · Interventional

TerminatedNot applicableResults postedRegistry data

Use of Teriparatide to Accelerate Fracture Healing

NCTNCT00594906 (opens ClinicalTrials.gov in a new tab)Other idP50AR054041Other idP50AR054041
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Not applicable
Enrollment
10 participants (actual)
Sponsor
University of Rochester · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Jan 2008
Primary completion
Jul 2012
Completion
Jul 2012
First posted
16 Jan 2008 (estimated)
Last update posted
19 Dec 2014 (estimated)
Conditions
Pelvic Fracture

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010201120122013
  1. N/A

    Use of Teriparatide to Accelerate Fracture Healing

    NCT00594906

    Jan 2008 to Jul 2012

    Terminated

Registry summary

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

The purpose of this study is to compare the effect of the drug teriparatide to the effect of placebo on pelvic fracture healing.

Interventions

  • TeriparatideDrug
  • PlaceboDrug

Arms2

  • Active comparator

    Injection

    30 participants will receive teriparatide (Forteo) injection pens.

  • Placebo comparator

    Placebo

    30 participants will receive placebo injection pens.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Healing of a Fracture From a Low Energy Fall

    Time frame · Measured at 16 weeks

    Registry description

    Callus formation at the fracture site as defined by a CT scan to determine healing (early/beginning callus formation) or healed (complete callus formation)

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 outcomeNumber· Measured at 16 weeks

Healing of a Fracture From a Low Energy Fall

GroupValue (participants)
Placebo Patients0
Forteo Patients1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Forteo InjectionPatients who randomized to the study drug, Forteo–0 / 71 / 7
Placebo InjectionPatients who were randomized to Placebo–0 / 30 / 3

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Females must be menopausal (no menses within the last 12 months) * Low energy fragility fractures of the pelvis, including anterior column, posterior column, inferior or superior rami, or sacrum * Maximum of 2 weeks post fracture * Mental status consistent with completing the study protocol Exclusion Criteria: * Currently receiving any treatment for osteoporosis, including estrogen and estrogenic-like compounds * Received radiation treatment to any site at any time in the past * Received chemotherapy for cancer at any time in the past * Any active cancer * Surgical repair (or attempted repair) of the fracture site in the pelvis * Use of any bone-active medications * Use of anticonvulsant therapy * Use of immunosuppressants * Any renal, gastrointestinal, liver, or metabolic bone disease * Pregnancy * High calcium, parathyroid hormone, or alkaline phosphatase, as based on laboratory results

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