NCT01292252

Brief Summary

The purpose of this study is to determine the effects of 12 weeks of daily treatment with teriparatide on spine fusion in adult patients who are undergoing multi-level posterolateral spine fusion surgery for degenerative conditions of the lumbar spine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

February 17, 2021

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

4.3 years

First QC Date

February 7, 2011

Results QC Date

December 8, 2020

Last Update Submit

April 29, 2021

Conditions

Lumbar SpondylosisLumbar SpondylolisthesisAdult Degenerative Lumbar Scoliosis

Outcome Measures

Primary Outcomes (2)

  • Quality of Spine Fusion, Measured by the Number of Participants With Complete Spine Fusion at 1 Year

    Quality of spine fusion, measured by the number of participants with complete spine fusion at 1 year. Spine fusion at one year was assessed using thin-section helical computed tomography (CT) scan of the lumbar spine.

    One year

  • Time to Spine Fusion

    One year

Secondary Outcomes (2)

  • Patient Reported Outcomes Measured by: Visual Analog Score (VAS), European Quality of Life - 5 Dimensions (EQ-5D) and Oswestry Disability Index (ODI) Scores at 1 Year

    One year

  • Adverse Effects

    One year

Study Arms (2)

Treatment

EXPERIMENTAL

Forteo, Terapeptide 20 ug subcutaneous injection

Biological: teriparatide

Control

PLACEBO COMPARATOR

Saline placebo

Biological: Placebo

Interventions

teriparatideBIOLOGICAL

Teriparatide 20 ug subcutaneous injection daily for 12 weeks

Also known as: Forteo, recombinant human parathyroid hormone (1-34)
Treatment
PlaceboBIOLOGICAL

Saline solution

Control

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 60-90 years with lumbar spondylosis, spondylolithesis, or adult degenerative scoliosis, including disc pathology, stenosis, deformity, instability, or postdecompression revision, who are scheduled to undergo three-level or greater posterolateral lumbar spinal fusion.
  • Willing and able to use a pen-type delivery system to administer daily subcutaneous injections.

You may not qualify if:

  • Use of bone morphogenic protein (BMP) posterolaterally during the fusion procedure.
  • Previous spinal fusion at the intended fusion levels.
  • Prior use of Forteo (teriparatide).
  • Use of digoxin.
  • Paget's Disease of bone.
  • History of primary skeletal malignancy, presence of bone metastases, or previous skeletal exposure to therapeutic irradiation.
  • Elevated serum calcium, serum PTH \>70 pg/ml, 25-hydroxyvitamin D \<12 ng/mL, or active liver disease.
  • History of symptomatic nephro- or urolithiasis in the past two years.
  • History of malignant neoplasm in the past five years, except for superficial basal cell carcinoma or squamous cell carcinoma.
  • Carcinoma in situ of the uterine cervix treated in the past year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Spine Center

San Francisco, California, 94143, United States

Location

Related Links

MeSH Terms

Conditions

SpondylosisSpondylolisthesis

Interventions

TeriparatideParathyroid Hormone

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesSpondylolysis

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Shane Burch, MD
Organization
University of California, San Francisco
Shane.Burch@ucsf.edu
415-353-4487

Study Officials

  • Shane Burch, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Carmen Li

    University of California, San Francisco

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 7, 2011

First Posted

February 9, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

May 3, 2021

Results First Posted

February 17, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)