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Use of Teriparatide to Accelerate Fracture Healing

Primary Purpose

Pelvic Fracture

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Teriparatide
Placebo
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Fracture focused on measuring Fracture Healing, Teriparatide, Forteo, Pelvic Fractures

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Injection

Placebo

Arm Description

30 participants will receive teriparatide (Forteo) injection pens.

30 participants will receive placebo injection pens.

Outcomes

Primary Outcome Measures

Healing of a Fracture From a Low Energy Fall
Callus formation at the fracture site as defined by a CT scan to determine healing (early/beginning callus formation) or healed (complete callus formation)

Secondary Outcome Measures

Full Information

First Posted
January 7, 2008
Last Updated
December 3, 2014
Sponsor
University of Rochester
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00594906
Brief Title
Use of Teriparatide to Accelerate Fracture Healing
Official Title
Use of Teriparatide to Accelerate Fracture Healing
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to poor enrollment.
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the effect of the drug teriparatide to the effect of placebo on pelvic fracture healing.
Detailed Description
Teriparatide is a man-made form of a naturally occurring hormone called parathyroid. It increases bone density and bone strength to help prevent fractures and can be used to treat osteoporosis in people who have a high risk of bone fracture. The purpose of this study is to compare the effect of teriparatide to the effect of placebo on pelvic fracture healing. This study will last 16 weeks. Participants will be randomly assigned to receive either teriparatide or placebo for the duration of the study. Participants will also be given calcium and vitamin D supplements to take daily throughout the study. At 4-week intervals, participants will undergo functional evaluations that will include the instrumented sit-to-stand test, the timed-up-and-go, and a gait velocity test. Participants will also undergo a DXA scan upon enrollment; undergo a CT evaluation upon enrollment and 16 weeks post-fracture; and complete specific pain, self-perceived function, mental status, and depression scales throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Fracture
Keywords
Fracture Healing, Teriparatide, Forteo, Pelvic Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Injection
Arm Type
Active Comparator
Arm Description
30 participants will receive teriparatide (Forteo) injection pens.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
30 participants will receive placebo injection pens.
Intervention Type
Drug
Intervention Name(s)
Teriparatide
Other Intervention Name(s)
Forteo
Intervention Description
Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)
Primary Outcome Measure Information:
Title
Healing of a Fracture From a Low Energy Fall
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)
Time Frame
Measured at 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J.Edward Puzas, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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Use of Teriparatide to Accelerate Fracture Healing

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