Comparation of Treatment Strategies for OVF: Teriparatide Injection and PVP

N/AActive Not RecruitingNCT03692143

Nanfang Hospital, Southern Medical University90 enrolled

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.

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

OBSERVATIONAL

Enrollment

Conditions

Osteoporosis, Postmenopausal Vertebral Fracture Quality of Life

Interventions

TeriparatideDRUG

subcutaneous injection of teriparatide(20 mg) once daily

PVPPROCEDURE

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

AlendronateDRUG

Alendronate Sodium, oral, 70mg, once a week

Eligibility

Sex: FEMALEMin age: 49 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Quality of life of the patients

The quality of life will be evaluated with SF-36 questionaire

Time frame: Change from pre treatment at 3 months, 6 months, 1 year and 2 years post treatment

Secondary Outcomes

Pain cause by the fracture

VAS score will be used to evaluate the pain caused by OVF

Time frame: Change from pre treatment at 3 months, 6 months, 1 year and 2 years post treatment

Bone healing

Bone healing will be evaluated with MRI scanning

Time frame: 3 month after treatment

Bone mineral density

Bone mineral density will be evaluated with DEXA.

Time frame: Change from pre treatment at 6 months, 1 year and 2 years post treatment

Data from ClinicalTrials.gov

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