Pilot Study of Fosamax in Spinal Cord Injury
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Fosamax Fosamax at 70 mgs q weekly by mouth for the duration of the study. |
Drug: Fosamax
70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
Other Names:
|
| Placebo Comparator: Placebo Sugar Pill Double blind study using Fosamax versus placebo. Placebo is an inactive drug. |
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Bone Mineral Density [1 year after enrollment]
Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis
Eligibility Criteria
Criteria
Inclusion Criteria:
- American Spinal Cord Injury Association (ASIA) A or American Spinal Cord Injury Association (ASIA) B Spinal Cord Injury
Exclusion Criteria:
-
History of hypersensitivity to alendronate or other bisphosphonates
-
esophageal abnormality
-
inability to sit/stand upright for 30 minutes
-
creatinine clearance less than 35 milliliters/minute
-
hypothyroidism
-
malignancy
-
pregnancy
-
prolonged steroid use
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Rochester Physical Medicine and Rehabilitation | Rochester | New York | United States | 14642 |
| 2 | University of Rochester | Rochester | New York | United States | 14642 |
Sponsors and Collaborators
- University of Rochester
Investigators
- Principal Investigator: Kanakadurga R Poduri, M.D., University of Rochester
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- U of R 29563
Study Results
Participant Flow
| Recruitment Details | 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). |
|---|---|
| Pre-assignment Detail | 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 |
| Arm/Group Title | Fosamax | Placebo Sugar Pill |
|---|---|---|
| Arm/Group Description | Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year | 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. |
| Period Title: Overall Study | ||
| STARTED | 1 | 0 |
| COMPLETED | 1 | 0 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Fosamax | Placebo Sugar Pill | Total |
|---|---|---|---|
| Arm/Group Description | Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year | 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. | Total of all reporting groups |
| Overall Participants | 1 | 0 | 1 |
| Age (participants) [Number] | |||
| <=18 years |
0
0%
|
0
NaN
|
|
| Between 18 and 65 years |
1
100%
|
1
Infinity
|
|
| >=65 years |
0
0%
|
0
NaN
|
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
58
(0)
|
58
(0)
|
|
| Gender (participants) [Number] | |||
| Female |
0
0%
|
0
NaN
|
|
| Male |
1
100%
|
1
Infinity
|
|
| Region of Enrollment (participants) [Number] | |||
| United States |
1
100%
|
1
Infinity
|
|
Outcome Measures
| Title | Bone Mineral Density |
|---|---|
| Description | Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis |
| Time Frame | 1 year after enrollment |
Outcome Measure Data
| Analysis Population Description |
|---|
| No analysis performed as there was only one patient who participated in this study |
| Arm/Group Title | Fosamax | Placebo Sugar Pill |
|---|---|---|
| Arm/Group Description | Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year | 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. |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Fosamax | Placebo Sugar Pill | ||
| Arm/Group Description | Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year | 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. | ||
All Cause Mortality |
||||
| Fosamax | Placebo Sugar Pill | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Fosamax | Placebo Sugar Pill | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
| Fosamax | Placebo Sugar Pill | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/0 (NaN) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | K.Rao Poduri, M.D., Chair of Physical Medicine & Rehab |
|---|---|
| Organization | University of Rochester |
| Phone | 585-275-6978 |
| kr_poduri@urmc.rochester.edu |
- U of R 29563