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Only 1 participant enrolled since the beginning of this study
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Study is designed to evaluate the efficacy of oral fosamax in prevention on osteoporosis in acute spinal cord injury. Efficacy will be measured by a duel energy X-Ray absorptiometry (DEXA) scan every 6 months. Patients will complete 3 visits, screening, 6 months, 12 months and be required to take oral fosamax versus placebo weekly.
The project was funded on August 13, 2009 and was awarded to one of our trainees, Dr. Matthew Abraham, a PGY3 in our program and our IRB approval was obtained with much time and effort on February 24, 2010. We followed the protocol and so far we recruited just one patient on September 19, 2011 who completed the study but we encountered with many unexpected obstacles to recruit any more patients to the study. The main obstacle was that the spine surgeons' refusal to start the study drug for months after surgery for fear of complications with wound healing. Secondly, the few appropriate and eligible patients we tried to recruit declined to participate.
We were unable to recruit any more patients to this study and hence the study was closed.
The one patient that was recruited completed the study. Since it is only one subject in the study, no conclusions can be drawn.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fosamax | Active Comparator | Fosamax at 70 mgs q weekly by mouth for the duration of the study. |
|
| Placebo Sugar Pill | Placebo Comparator | Double blind study using Fosamax versus placebo. Placebo is an inactive drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fosamax | Drug | 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density | Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis | 1 year after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kanakadurga R Poduri, M.D. | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Physical Medicine and Rehabilitation | Rochester | New York | 14642 | United States | ||
Recruitment beyond one patient was not possible due to A. surgeons unwillingness to initiate Fosomax treatment for fear of wound healing. B. The eligible patients' reluctance to participate in the study. C. Given the length of time it took to enroll one, it is not feasible to complete the study with required # in the protocol in the next few years
A 57 year old T4 paraplegic was recruited while he was going through rehabilitation at Strong Memorial Hospital inpatient rehab unit. This patient was recruited and signed consent on 8/05/2011.He underwent lab work and dexa scan per protocol and on completion of the investigation on September 19, 2011 he started the treatment(Fosamax vs. Placebo).
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| ID | Title | Description |
|---|---|---|
| FG000 | Fosamax | Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year |
| FG001 | Placebo Sugar Pill | Double blind study using Fosamax versus placebo. Placebo is an inactive drug. Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fosamax | Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year |
| BG001 | Placebo Sugar Pill | Double blind study using Fosamax versus placebo. Placebo is an inactive drug. Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| 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 | Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis | No analysis performed as there was only one patient who participated in this study | Posted | 1 year after enrollment |
|
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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 | Fosamax | Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| K.Rao Poduri, M.D., Chair of Physical Medicine & Rehab | University of Rochester | 585-275-6978 | kr_poduri@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D019386 | Alendronate |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo. |
|
|
| University of Rochester |
| Rochester |
| New York |
| 14642 |
| United States |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Placebo Sugar Pill | Double blind study using Fosamax versus placebo. Placebo is an inactive drug. Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo. | 0 | 0 | 0 | 0 |
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| D014947 | Wounds and Injuries |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002241 |
| Carbohydrates |