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Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01292252
First received: February 7, 2011
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Lumbar Spondylosis
Lumbar Spondylolisthesis
Adult Degenerative Lumbar Scoliosis
Biological: teriparatide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of the Efficacy of Forteo (Teriparatide) in Patients Undergoing Posterolateral Lumbar Spinal Fusion

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Quality of spine fusion [ Time Frame: One year ] [ Designated as safety issue: No ]
    Quality of spine fusion at one year will be assessed using thin-section helical CT scan of the lumbar spine.

  • Time to spine fusion [ Time Frame: One year ] [ Designated as safety issue: No ]
    Time to spine fusion will be determined using AP/lateral x-rays of the lumbar spine taken at 6 weeks, 3 months, 6 months, and 1 year after surgery.


Secondary Outcome Measures:
  • Clinical outcome [ Time Frame: One year ] [ Designated as safety issue: No ]
    Clinical outcomes will be assessed using self-reported pain Visual Analog Score (VAS), European Quality of Life - 5 Dimensions (EQ-5D), and Oswestry Disability Index (ODI) scores at the preoperative and postoperative follow-up visits.

  • Adverse effects [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Patient-reported adverse effects of study treatment will be recorded at the time of surgery and at all post-operative follow-up visits.


Estimated Enrollment: 90
Study Start Date: August 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Teriparatide treatment
Biological: teriparatide
Teriparatide 20 ug subcutaneous injection daily for 12 weeks
Other Names:
  • Forteo
  • recombinant human parathyroid hormone (1-34)
Placebo Comparator: Placebo
Placebo treatment
Biological: teriparatide
Teriparatide 20 ug subcutaneous injection daily for 12 weeks
Other Names:
  • Forteo
  • recombinant human parathyroid hormone (1-34)

Detailed Description:

For patients undergoing spine fusion surgery, non-fusion (or pseudarthrosis) is one of the major complications that can lead to poor clinical outcomes. Therefore, treatments that promote or augment fusion are highly desirable. Teriparatide (Forteo, recombinant human parathyroid hormone [1-34]) is a systemically administered peptide hormone that is FDA-approved for the treatment of osteoporosis in postmenopausal women or other populations at high risk for fracture. While teriparatide has been shown to enhance spinal fusion in several rodent and rabbit studies, no clinical studies to date have examined its effect on spinal fusion in humans.

This single-site two-year prospective randomized double-blind placebo-controlled study is designed to examine the effects of peri-operative teriparatide treatment in older adults undergoing multi-level posterolateral lumbar spine fusion. All eligible patients seen at the UCSF Spine Center will be invited to enroll in the study. Upon enrollment, patients will have screening labs drawn in conjunction with their routine pre-operative work-up, to include complete blood count (CBC), chemistry panel including calcium level, liver function tests (LFTs) including alkaline phosphatase, parathyroid hormone (PTH) level, and 25-hydroxyvitamin D level. If eligible after screening labs are completed, they will be scheduled for bone density (DEXA) scan and be randomized in a 2:1 ratio to receive daily subcutaneous injections of teriparatide 20 ug/d or placebo. The total duration of treatment will be 12 weeks, with two weeks pre-operative and 10 weeks post-operative treatment.

Patients will be scheduled to attend all standard post-operative follow-up clinic visits, which will be at 6 weeks, 3 months, 6 months, and 12 months after surgery. At 3 months post operative visit, patients will have lab drawn for calcium. At each follow-up visit, AP and lateral x-ray radiographs will be taken of the lumber spine to assess progression of bone healing and positioning of any hardware placed. Participants will be asked to complete a pain Visual Analog Score (VAS), European Quality of Life-5 Dimensions (EQ-5D), and Oswestry Disability Index (ODI) questionnaire at each visit for assessment of clinical outcomes. Thin-section helical CT scans of the lumbar spine will be taken at 12 months after surgery for definitive assessment of fusion. All radiographs will be evaluated by a blinded panel of three reviewers including a radiologist and a spine surgeon to assess primary outcome.

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292252

Contacts
Contact: Lori Justice 415-476-1167 JusticeL@orthosurg.ucsf.edu
Contact: Carmen Li 415-476-6184 lic@orthosurg.ucsf.edu

Locations
United States, California
UCSF Spine Center Recruiting
San Francisco, California, United States, 94143
Contact: Marilyn Banks    415-353-4487    Marilyn.Banks@ucsfmedctr.org   
Contact: Carmen Li    415-476-6184    LiC@orthosurg.ucsf.edu   
Sub-Investigator: Christopher Ames, MD         
Sub-Investigator: Sigurd Berven, MD         
Sub-Investigator: Dean Chou, MD         
Principal Investigator: Shane Burch, MD         
Sub-Investigator: Vedat Deviren, MD         
Sub-Investigator: Bobby Tay, MD         
Sub-Investigator: Praveen Mummaneni, MD         
Sub-Investigator: Philip Weinstein, MD         
Sponsors and Collaborators
University of California, San Francisco
Eli Lilly and Company
Investigators
Principal Investigator: Shane Burch, MD University of California, San Francisco
Study Director: Carmen Li University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01292252     History of Changes
Other Study ID Numbers: UCSFSpineForteo
Study First Received: February 7, 2011
Last Updated: April 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Spondylolisthesis
Spondylosis
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylolysis
Teriparatide
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014