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In a randomized, double-blind trial, BMD of the operated proximal femur after total hip replacement measured by dual-energy x-ray absorptiometry (DXA) were compared for up to two years in patients receiving IV ZOL 5 mg infusion (n = 27) or placebo (IV saline infusion; n = 24) at two weeks and one year after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Zoledronic Acid | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic acid | Drug | Zoledronic acid per protocol |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density (BMD) | Change in bone mineral density (BMD) (per dual energy x-ray absorptiometry (DXA) imaging) from 1 week post-operative data in the Standard and Custom Gruen Zones around the femoral stem. | 2 years post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo |
| FG001 | Zoledronic Acid | Zoledronic acid: Zoledronic acid per protocol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo |
| BG001 | Zoledronic Acid | Zoledronic acid: Zoledronic acid per protocol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bone Mineral Density (BMD) | Change in bone mineral density (BMD) (per dual energy x-ray absorptiometry (DXA) imaging) from 1 week post-operative data in the Standard and Custom Gruen Zones around the femoral stem. | Posted | Mean | Standard Deviation | Percent change | 2 years post-operative |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hepatic liver mass | Hepatobiliary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flu-like symptoms | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Spokane Joint Replacement Center | 509-466-6393 | dfscott@mac.com |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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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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| Placebo | Other | Placebo |
|
| BG002 |
| Total |
Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 24 |
| 2 |
| 24 |
| 0 |
| 24 |
| EG001 | Zoledronic Acid | Zoledronic acid: Zoledronic acid per protocol | 0 | 27 | 3 | 27 | 2 | 27 |
| THA revision | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Liver cancer | Hepatobiliary disorders | Non-systematic Assessment |
|
| Muscular atrophy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |