Comparation of Treatment Strategies for OVF: Teriparatide Injection and PVP

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03692143
• Other study ID #: NFEC-2018-067
• Status: Active, not recruiting
• Start date: January 1, 2017
• Est. completion date: December 1, 2030

Study information

• Verified date: July 2018
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 1, 2030
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 49 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Quality of Life
• Spinal Fractures
• Vertebral Fracture

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life of the patients	The quality of life will be evaluated with SF-36 questionaire	Change from pre treatment at 3 months, 6 months, 1 year and 2 years post treatment
Secondary	Pain cause by the fracture	VAS score will be used to evaluate the pain caused by OVF	Change from pre treatment at 3 months, 6 months, 1 year and 2 years post treatment
Secondary	Bone healing	Bone healing will be evaluated with MRI scanning	3 month after treatment
Secondary	Bone mineral density	Bone mineral density will be evaluated with DEXA.	Change from pre treatment at 6 months, 1 year and 2 years post treatment