Does Systemic Administration of Parathyroid Hormone after Noninstrumented Spinal Fusion Surgery Improve Fusion Rates and Fusion Mass in Elderly Patients Compared to Placebo in Patients With Degenerative Lumbar Spondylolisthesis?

Annette Bennedsgaard Jespersen*, Andreas Duch Kiilerich Andresen, Michael Kjær Jacobsen, Mikkel O Andersen, Leah Y Carreon

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

Study Design.Prospective, randomized, double-blinded, placebo-controlled clinical trial.Objective.To evaluate whether 90-day subcutaneous injections with 20 μg teriparatide increases the volume and quality of the fusion mass compared to placebo based on 12-month postop fine cut computed tomography scans. The secondary objective is to evaluate whether parathyroid hormone (PTH) increases fusion rates compared to placebo.Summary of Background Data.Few studies have investigated the effects of PTH on fusion in patients undergoing spinal arthrodesis. Early studies showed a more robust fusion mass with PTH after spinal fusion surgery. But the efficiency of PTH on noninstrumented spinal fusion surgery remains unclear.Methods.Patients with degenerative spondylolisthesis scheduled for noninstrumented posterolateral fusion were randomized to receive 90-day subcutaneous injections with 20 μg teriparatide (N = 41) or placebo (N = 46) in a 1:1 fashion. Fusion volume and quality was evaluated using 12-month postoperative fine cut computed tomography scans.Results.The two groups were comparable in terms of age, sex, and numbers of levels operated. PTH treatment was well tolerated but provided no additional benefit versus placebo. Fusion rates, the mean volume, and robustness of the fusion mass were similar between the PTH and placebo groups.Conclusion.Ninety-day subcutaneous administration of 20 μg teriparatide did not increase fusion volume or improve the quality of the fusion mass in elderly patients compared to placebo after noninstrumented spinal fusion surgery for degenerative spondylolisthesis.

Original languageEnglish
JournalSpine
Volume44
Issue number3
Pages (from-to)157-162
ISSN0362-2436
DOIs
Publication statusPublished - 1. Feb 2019

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Parathyroid Hormone
Placebos
Teriparatide
Controlled Clinical Trials

Keywords

  • double-blind placebo-controlled clinical trial
  • fusion rates
  • parathyroid hormone
  • posterolateral fusion

Cite this

@article{6bc2349e4a234eb5822e75f130cbd687,
title = "Does Systemic Administration of Parathyroid Hormone after Noninstrumented Spinal Fusion Surgery Improve Fusion Rates and Fusion Mass in Elderly Patients Compared to Placebo in Patients With Degenerative Lumbar Spondylolisthesis?",
abstract = "Study Design.Prospective, randomized, double-blinded, placebo-controlled clinical trial.Objective.To evaluate whether 90-day subcutaneous injections with 20 μg teriparatide increases the volume and quality of the fusion mass compared to placebo based on 12-month postop fine cut computed tomography scans. The secondary objective is to evaluate whether parathyroid hormone (PTH) increases fusion rates compared to placebo.Summary of Background Data.Few studies have investigated the effects of PTH on fusion in patients undergoing spinal arthrodesis. Early studies showed a more robust fusion mass with PTH after spinal fusion surgery. But the efficiency of PTH on noninstrumented spinal fusion surgery remains unclear.Methods.Patients with degenerative spondylolisthesis scheduled for noninstrumented posterolateral fusion were randomized to receive 90-day subcutaneous injections with 20 μg teriparatide (N = 41) or placebo (N = 46) in a 1:1 fashion. Fusion volume and quality was evaluated using 12-month postoperative fine cut computed tomography scans.Results.The two groups were comparable in terms of age, sex, and numbers of levels operated. PTH treatment was well tolerated but provided no additional benefit versus placebo. Fusion rates, the mean volume, and robustness of the fusion mass were similar between the PTH and placebo groups.Conclusion.Ninety-day subcutaneous administration of 20 μg teriparatide did not increase fusion volume or improve the quality of the fusion mass in elderly patients compared to placebo after noninstrumented spinal fusion surgery for degenerative spondylolisthesis.",
keywords = "double-blind placebo-controlled clinical trial, fusion rates, parathyroid hormone, posterolateral fusion",
author = "Jespersen, {Annette Bennedsgaard} and Andresen, {Andreas Duch Kiilerich} and Jacobsen, {Michael Kj{\ae}r} and Andersen, {Mikkel O} and Carreon, {Leah Y}",
year = "2019",
month = "2",
day = "1",
doi = "10.1097/BRS.0000000000002791",
language = "English",
volume = "44",
pages = "157--162",
journal = "Spine",
issn = "0362-2436",
publisher = "Lippincott Williams & Wilkins",
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TY - JOUR

T1 - Does Systemic Administration of Parathyroid Hormone after Noninstrumented Spinal Fusion Surgery Improve Fusion Rates and Fusion Mass in Elderly Patients Compared to Placebo in Patients With Degenerative Lumbar Spondylolisthesis?

AU - Jespersen, Annette Bennedsgaard

AU - Andresen, Andreas Duch Kiilerich

AU - Jacobsen, Michael Kjær

AU - Andersen, Mikkel O

AU - Carreon, Leah Y

PY - 2019/2/1

Y1 - 2019/2/1

N2 - Study Design.Prospective, randomized, double-blinded, placebo-controlled clinical trial.Objective.To evaluate whether 90-day subcutaneous injections with 20 μg teriparatide increases the volume and quality of the fusion mass compared to placebo based on 12-month postop fine cut computed tomography scans. The secondary objective is to evaluate whether parathyroid hormone (PTH) increases fusion rates compared to placebo.Summary of Background Data.Few studies have investigated the effects of PTH on fusion in patients undergoing spinal arthrodesis. Early studies showed a more robust fusion mass with PTH after spinal fusion surgery. But the efficiency of PTH on noninstrumented spinal fusion surgery remains unclear.Methods.Patients with degenerative spondylolisthesis scheduled for noninstrumented posterolateral fusion were randomized to receive 90-day subcutaneous injections with 20 μg teriparatide (N = 41) or placebo (N = 46) in a 1:1 fashion. Fusion volume and quality was evaluated using 12-month postoperative fine cut computed tomography scans.Results.The two groups were comparable in terms of age, sex, and numbers of levels operated. PTH treatment was well tolerated but provided no additional benefit versus placebo. Fusion rates, the mean volume, and robustness of the fusion mass were similar between the PTH and placebo groups.Conclusion.Ninety-day subcutaneous administration of 20 μg teriparatide did not increase fusion volume or improve the quality of the fusion mass in elderly patients compared to placebo after noninstrumented spinal fusion surgery for degenerative spondylolisthesis.

AB - Study Design.Prospective, randomized, double-blinded, placebo-controlled clinical trial.Objective.To evaluate whether 90-day subcutaneous injections with 20 μg teriparatide increases the volume and quality of the fusion mass compared to placebo based on 12-month postop fine cut computed tomography scans. The secondary objective is to evaluate whether parathyroid hormone (PTH) increases fusion rates compared to placebo.Summary of Background Data.Few studies have investigated the effects of PTH on fusion in patients undergoing spinal arthrodesis. Early studies showed a more robust fusion mass with PTH after spinal fusion surgery. But the efficiency of PTH on noninstrumented spinal fusion surgery remains unclear.Methods.Patients with degenerative spondylolisthesis scheduled for noninstrumented posterolateral fusion were randomized to receive 90-day subcutaneous injections with 20 μg teriparatide (N = 41) or placebo (N = 46) in a 1:1 fashion. Fusion volume and quality was evaluated using 12-month postoperative fine cut computed tomography scans.Results.The two groups were comparable in terms of age, sex, and numbers of levels operated. PTH treatment was well tolerated but provided no additional benefit versus placebo. Fusion rates, the mean volume, and robustness of the fusion mass were similar between the PTH and placebo groups.Conclusion.Ninety-day subcutaneous administration of 20 μg teriparatide did not increase fusion volume or improve the quality of the fusion mass in elderly patients compared to placebo after noninstrumented spinal fusion surgery for degenerative spondylolisthesis.

KW - double-blind placebo-controlled clinical trial

KW - fusion rates

KW - parathyroid hormone

KW - posterolateral fusion

U2 - 10.1097/BRS.0000000000002791

DO - 10.1097/BRS.0000000000002791

M3 - Journal article

VL - 44

SP - 157

EP - 162

JO - Spine

JF - Spine

SN - 0362-2436

IS - 3

ER -