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NCT Number: NCT03692143

Comparation of Treatment Strategies for OVF: Teriparatide Injection and PVP

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteoporosis, Postmenopausal Back Injuries Bone Diseases Bone Diseases, Metabolic Fractures, Bone Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Quality of Life Spinal Fractures Spinal Injuries Vertebral Fracture Wounds and Injuries

Age range

49 year–99 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teriparatide

Drug

subcutaneous injection of teriparatide(20 mg) once daily

PVP

Procedure

With local anesthesia, bone cement was injected in to fractured body in a needle that penetrated transpedically and percutaneously

Alendronate

Drug

Alendronate Sodium, oral, 70mg, once a week

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Bone healing

    Time frame: 3 month after treatment

    Bone healing will be evaluated with MRI scanning

  3. 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.

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2025
Study completion
2030
First posted
Oct 2, 2018
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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