Comparation of Treatment Strategies for OVF: Teriparatide Injection and PVP

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoporosis, Postmenopausal, Vertebral Fracture, Quality of Life

Intervention / Treatment
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* Drug: Teriparatide
* Procedure: PVP
* Drug: Alendronate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 49 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| teriparatide group<br>The group of postmenopausal women who diagnosis with osteoporotic fractures treated with teriparatide | Drug: Teriparatide<br>* subcutaneous injection of teriparatide(20 mg) once daily<br>|
| PVP group plus alendronate<br>The group of postmenopausal women who diagnosis with osteoporotic fractures treated with vertebroplasty. Then alendronate was prescribed. | Procedure: PVP<br>* With local anesthesia, bone cement was injected in to fractured body in a needle that penetrated transpedically and percutaneously<br>Drug: Alendronate<br>* Alendronate Sodium, oral, 70mg, once a week<br>|
| teriparatide and PVP group<br>The group of postmenopausal women who diagnosis with osteoporotic fractures treated with teriparatide after vertebroplasty | Drug: Teriparatide<br>* subcutaneous injection of teriparatide(20 mg) once daily<br>Procedure: PVP<br>* With local anesthesia, bone cement was injected in to fractured body in a needle that penetrated transpedically and percutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Bone healing | Bone healing will be evaluated with MRI scanning | 3 month after treatment | 
| 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 |