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Role of Weekly Teriparatide Administration in Osseous Union Enhancement within Six Months After Posterior or Transforaminal Lumbar Interbody Fusion for Osteoporosis-Associated Lumbar Degenerative Disorders: A Multicenter, Prospective Randomized Study.

Abstract For elderly patients, posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF) is usually performed to treat lumbar degenerative diseases. However, some patients exhibit pseudarthrosis following such procedures. The anabolic agent teriparatide is an approved treatment for promoting bone formation in osteoporotic patients. Our multicenter, prospective randomized study assessed the role of once-weekly teriparatide administration on patient outcomes following interbody fusion.
PMID
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Authors

Mayor MeshTerms

Spinal Fusion

Keywords
Journal Title the journal of bone and joint surgery. american volume
Publication Year Start




PMID- 28244906
OWN - NLM
STAT- MEDLINE
DA  - 20170228
DCOM- 20170308
LR  - 20170308
IS  - 1535-1386 (Electronic)
IS  - 0021-9355 (Linking)
VI  - 99
IP  - 5
DP  - 2017 Mar 01
TI  - Role of Weekly Teriparatide Administration in Osseous Union Enhancement within
      Six Months After Posterior or Transforaminal Lumbar Interbody Fusion for
      Osteoporosis-Associated Lumbar Degenerative Disorders: A Multicenter, Prospective
      Randomized Study.
PG  - 365-372
LID - 10.2106/JBJS.16.00230 [doi]
AB  - BACKGROUND: For elderly patients, posterior lumbar interbody fusion (PLIF) or
      transforaminal lumbar interbody fusion (TLIF) is usually performed to treat
      lumbar degenerative diseases. However, some patients exhibit pseudarthrosis
      following such procedures. The anabolic agent teriparatide is an approved
      treatment for promoting bone formation in osteoporotic patients. Our multicenter,
      prospective randomized study assessed the role of once-weekly teriparatide
      administration on patient outcomes following interbody fusion. METHODS: Patients 
      were females who were >/=50 years of age, had a bone mineral density (BMD) of
      <80% of the sex-matched young adult mean and/or previous spinal compression or
      femoral fractures, and had lumbar degenerative disease. Patients were randomly
      allocated to receive either weekly teriparatide, administered subcutaneously
      starting at week 1, for 6 months postoperatively (the teriparatide arm), or no
      teriparatide (the control arm). Blinded radiographic evaluations were performed
      using dynamic radiography and computed tomography (CT) and assessed by modified
      intention-to-treat analysis and per-protocol analysis. Clinical and neurological 
      symptoms were evaluated using the Japanese Orthopaedic Association Back Pain
      Evaluation Questionnaire (JOA-BPEQ) and the Oswestry Disability Index (ODI).
      RESULTS: Seventy-five patients were randomized to treatment, and 66 patients
      completed treatment. At 4 months postoperatively, bone fusion in the 2 center CT 
      slices was significantly higher in the teriparatide arm compared with the control
      arm in the age-adjusted modified intention-to-treat analysis and was
      significantly higher at 6 months in the per-protocol analysis. Radiographic
      examinations showed no disc-space narrowing and no intervertebral disc
      instability. JOA-BPEQ and ODI results were improved postoperatively in both
      treatment arms. CONCLUSIONS: Weekly administration of teriparatide promoted bone 
      formation at the surgical fusion site and decreased bone resorption, as indicated
      by bone metabolic marker results, within the early postoperative period. Our
      findings suggest that combining lumbar interbody fusion and teriparatide
      treatment may be an effective option for managing lumbar degenerative disease in 
      elderly patients. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for
      Authors for a complete description of levels of evidence.
FAU - Ebata, Shigeto
AU  - Ebata S
AD  - 1Departments of Orthopaedic Surgery (S.E., T.O., and H.H.) and Health Science for
      Clinical Medicine (Z.Y.), Graduate School of Medicine, University of Yamanashi,
      Chuo, Yamanashi, Japan 2Department of Orthopaedic Surgery, Shinshu University
      School of Medicine, Matsumoto, Nagano, Japan 3Departments of Orthopaedic Surgery 
      (T.H. and Y.M.) and Community Health and Preventive Medicine (Y.S. and T.O.),
      Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan 4Medical
      Affairs Department, Pharmaceutical Business Administration Division, Asahi Kasei 
      Pharma Corporation, Tokyo, Japan.
FAU - Takahashi, Jun
AU  - Takahashi J
FAU - Hasegawa, Tomohiko
AU  - Hasegawa T
FAU - Mukaiyama, Keijiro
AU  - Mukaiyama K
FAU - Isogai, Yukihiro
AU  - Isogai Y
FAU - Ohba, Tetsuro
AU  - Ohba T
FAU - Shibata, Yosuke
AU  - Shibata Y
FAU - Ojima, Toshiyuki
AU  - Ojima T
FAU - Yamagata, Zentaro
AU  - Yamagata Z
FAU - Matsuyama, Yukihiro
AU  - Matsuyama Y
FAU - Haro, Hirotaka
AU  - Haro H
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Bone Joint Surg Am
JT  - The Journal of bone and joint surgery. American volume
JID - 0014030
RN  - 0 (Bone Density Conservation Agents)
RN  - 10T9CSU89I (Teriparatide)
SB  - AIM
SB  - IM
MH  - Aged
MH  - Bone Density Conservation Agents/*administration & dosage
MH  - Female
MH  - Fracture Healing/*drug effects
MH  - Humans
MH  - Intervertebral Disc Degeneration/etiology/*surgery
MH  - Lumbar Vertebrae/diagnostic imaging/*drug effects/surgery
MH  - Middle Aged
MH  - Osteogenesis/drug effects
MH  - Osteoporosis/complications/drug therapy
MH  - Prospective Studies
MH  - Pseudarthrosis/etiology/prevention & control
MH  - *Spinal Fusion
MH  - Teriparatide/*administration & dosage
MH  - Wound Healing/drug effects
EDAT- 2017/03/01 06:00
MHDA- 2017/03/09 06:00
CRDT- 2017/03/01 06:00
AID - 10.2106/JBJS.16.00230 [doi]
AID - 00004623-201703010-00001 [pii]
PST - ppublish
SO  - J Bone Joint Surg Am. 2017 Mar 1;99(5):365-372. doi: 10.2106/JBJS.16.00230.

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