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Study halted prematurely, prior to enrollment of first participant, for strategic reasons
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It's to investigate the efficacy of Zoledronic acid treatment on the early prosthetic fixation in post-menopausal osteoporosis women under cementless total hip arthroplasty after 24-month observation.
To investigate the efficacy of Zoledronic acid and placebo treatment on the prosthetic transverse translation in post-menopausal osteoporosis women under cementless total hip arthroplasty by Radiostereometry (RSA)in two-year follow-up period .
Meanwhile to assess efficacy of Zoledronic acid treatment on the vertical translation of acetabulum and the subsidence translation of femoral stem by Radiostereometry(RSA), prevention of peri- prosthetic bone loss by observing the local average bone mineral density ( BMD ) changes for 7 femoral region Gruen zones through Dual Energy X-ray Absorptiometry (DXA)scans, et al.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoledronic acid 5mg | Experimental | interventional group which receive yearly Zoledronic acid 5mg/100ml infusion treatment for two years |
|
| blank | No Intervention | blank group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic acid 5mg | Drug | two-year Zoledronic acid 5mg infusion treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| the transverse translation (μm) | the transverse translation (μm, outside-inside) between acetabular prosthesis markers and reference point | baseline and month12,month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| average bone mineral density ( BMD ) | the local average bone mineral density ( BMD ) changes for 7 femoral region Gruen zones through Dual Energy X-ray Absorptiometry (DXA)scans. | 1w,6m,12m and 24m after THA operation |
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Inclusion Criteria:
Patients who was diagnosed with Post-menopausal osteoporosis( bone mineral density T<-2.5;or with previous fragility fracture, bone mineral density T -2.5~-1.5), responding to Zoledronic acid, within one week after the successful cementless total hip arthroplasty surgery.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Shanghai | Shanghai Municipality | 200011 | China |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |