Use of Teriparatide to Accelerate Fracture Healing

NCT00594906 | Terminated Results

• 1 other identifier: P50AR054041
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Fracture

Keywords

Fracture Healing; Teriparatide; Forteo; Pelvic Fractures

Outcome Measures

Primary Outcomes (1)

• 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)

  Measured at 16 weeks

Study Arms (2)

Injection

ACTIVE COMPARATOR

30 participants will receive teriparatide (Forteo) injection pens.

Drug: Teriparatide

Placebo

PLACEBO COMPARATOR

30 participants will receive placebo injection pens.

Drug: Placebo

Interventions

Teriparatide DRUG

Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)

Also known as: Forteo

Injection

Placebo DRUG

Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. J. Edward Puzas
• Organization: University of Rochester

edward_puzas@urmc.rochester.edu

(585) 275-3664

Study Officials

• J.Edward Puzas, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 19, 2014
• Results First Posted: April 24, 2013

Record last verified: 2013-03

Locations

US (1)