Comparation of Treatment Strategies for OVF: Teriparatide Injection and PVP

Overview

This study aimed to compare teriparatide treatments and PVPs, focusing on its effects on life qualities and effect/coast ratio and evaluate which method is better for patients.

Full Title of Study: “Effect and Cost Comparation of Different Treatment Strategies for Osteoporotic Vertebral Fractures (OVF): Teriparatide Injection and Percutaneous Vertebroplasty (PVP)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 1, 2025

Detailed Description

Osteoporosis and osteoporotic vertebral fracture (OVF)s are the common diseases that affect the qualities of senior people. The general treatments for OVFs including percutaneous vertebroplasty (PVP) operation and conservative treatments with pain killers. But with the widely used methods, the life quality of patients were still not satisfied. Teriparatide has been proven to increase bone qualities in patients with severe osteoporosis and reduced the fracture possibilities. The investigators' previous clinical observation found teriparatide could be applied to treat fresh OVFs. 90 participants who diagnosed fresh OVFS were included in the trial. After they received each of three kinds of interventions mentioned in this study, The investigators followed up all these cases. Once 30 cases goal reaches in a certain group, the data collection in that special will stop automatically. The quality of life, pain score and BMDs will be evaluated in certain time during the trial.

Interventions

  • Drug: Teriparatide
    • subcutaneous injection of teriparatide(20 mg) once daily
  • Procedure: PVP
    • With local anesthesia, bone cement was injected in to fractured body in a needle that penetrated transpedically and percutaneously
  • Drug: Alendronate
    • Alendronate Sodium, oral, 70mg, once a week

Arms, Groups and Cohorts

  • teriparatide group
    • The group of postmenopausal women who diagnosis with osteoporotic fractures treated with teriparatide
  • PVP group plus alendronate
    • The group of postmenopausal women who diagnosis with osteoporotic fractures treated with vertebroplasty. Then alendronate was prescribed.
  • teriparatide and PVP group
    • The group of postmenopausal women who diagnosis with osteoporotic fractures treated with teriparatide after vertebroplasty

Clinical Trial Outcome Measures

Primary Measures

  • Quality of life of the patients
    • Time Frame: Change from pre treatment at 3 months, 6 months, 1 year and 2 years post treatment
    • The quality of life will be evaluated with SF-36 questionaire

Secondary Measures

  • Pain cause by the fracture
    • Time Frame: Change from pre treatment at 3 months, 6 months, 1 year and 2 years post treatment
    • VAS score will be used to evaluate the pain caused by OVF
  • Bone healing
    • Time Frame: 3 month after treatment
    • Bone healing will be evaluated with MRI scanning
  • Bone mineral density
    • Time Frame: Change from pre treatment at 6 months, 1 year and 2 years post treatment
    • Bone mineral density will be evaluated with DEXA.

Participating in This Clinical Trial

Inclusion Criteria

  • 1.postmenopausal women with osteoporotic fractures 2.treated with teriparatide 3.or treated with vertebroplasty 4.or treated with teriparatide after vertebroplasty 5.or treated with Fosamax 6. willing to anticipate the trial Exclusion Criteria:

  • Serious other illness or disease which effecting quality of life occurs later in treatment – unwilling to anticipate the trial

Gender Eligibility: Female

Minimum Age: 49 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nanfang Hospital, Southern Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dehong Yang, MD,PhD, Principal Investigator, Nanfang Hospital, Southern Medical University

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