Osteoporosis, Postmenopausal, Vertebral Fracture, Quality of Life
Conditions
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.
Interventions
DRUGTeriparatide
subcutaneous injection of teriparatide(20 mg) once daily
PROCEDUREPVP
With local anesthesia, bone cement was injected in to fractured body in a needle that penetrated transpedically and percutaneously
DRUGAlendronate
Alendronate Sodium, oral, 70mg, once a week
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
49 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed