Osteoporosis, Spinal Cord Injury
Conditions
Keywords
ASIA A or ASIA B Spinal Cord Injury
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.
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.
Interventions
DRUGFosamax
70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
DRUGPlacebo
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.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
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 details
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
Participants by arm
| Arm | Count |
|---|---|
| Fosamax Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year | 1 |
| 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 |
| Total | 1 |
Baseline characteristics
| Characteristic | Total | Fosamax |
|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants |
| Age, Categorical >=65 years | 0 participants | 0 participants |
| Age, Categorical Between 18 and 65 years | 1 participants | 1 participants |
| Age, Continuous | 58 years STANDARD_DEVIATION 0 | 58 years STANDARD_DEVIATION 0 |
| Gender Female | 0 participants | 0 participants |
| Gender Male | 1 participants | 1 participants |
| Region of Enrollment United States | 1 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Bone Mineral Density
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
Population: No analysis performed as there was only one patient who participated in this study