Comparation of Treatment Strategies for OVF: Teriparatide Injection and PVP

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 19, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

January 1, 2017

Estimated Primary Completion Date

March 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

Comparation of Treatment Strategies for OVF: Teriparatide Injection and PVP

Official Title ^ICMJE

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

Brief 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.

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.

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

: 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

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 1, 2030

Estimated Primary Completion Date

March 1, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Female

Ages

49 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Nanfang Hospital of Southern Medical University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Dehong Yang, MD ,PhD Nanfang Hospital of Southern Medical University

PRS Account

Verification Date

July 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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