Comparation of Treatment Strategies for OVF: Teriparatide Injection and PVP

Active, not recruiting

• Conditions: Osteoporosis, Postmenopausal; Vertebral Fracture; Quality of Life
• Interventions: Drug: Teriparatide; Procedure: PVP; Drug: Alendronate

• Registration Number: NCT03692143
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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 Timeline

• Study Start: 2017-01-01
• Status Verified: 2018-07
• Study First Submitted: 2018-09-19
• Study First Submitted QC: 2018-09-28
• Last Update Submitted: 2018-09-28
• Study First Posted: 2018-10-02
• Last Update Posted: 2018-10-02
• Primary Completion: 2025-03-01
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
teriparatide group	Teriparatide	The group of postmenopausal women who diagnosis with osteoporotic fractures treated with teriparatide
PVP group plus alendronate	PVP	The group of postmenopausal women who diagnosis with osteoporotic fractures treated with vertebroplasty. Then alendronate was prescribed.
PVP group plus alendronate	Alendronate	The group of postmenopausal women who diagnosis with osteoporotic fractures treated with vertebroplasty. Then alendronate was prescribed.
teriparatide and PVP group	Teriparatide	The group of postmenopausal women who diagnosis with osteoporotic fractures treated with teriparatide after vertebroplasty
teriparatide and PVP group	PVP	The group of postmenopausal women who diagnosis with osteoporotic fractures treated with teriparatide after vertebroplasty

Primary Outcome Measures

Name	Time	Method
Quality of life of the patients	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 Outcome Measures

Name	Time	Method
Pain cause by the fracture	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	3 month after treatment	Bone healing will be evaluated with MRI scanning
Bone mineral density	Change from pre treatment at 6 months, 1 year and 2 years post treatment	Bone mineral density will be evaluated with DEXA.