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Incomplete data set & analysis
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Spaulding Rehabilitation Hospital | OTHER |
| VA Boston Healthcare System | FED |
| Massachusetts General Hospital |
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This is a research study to determine the effects of functional electrical stimulation (FES) rowing and a drug called zoledronic acid in bone health. The investigators hoped to learn if zoledronic acid treatment will increase bone mineral density in persons with chronic spinal cord injury (SCI) who received it. The investigators also want to find out if zoledronic acid is safe for persons with SCI to take without causing too many side effects.
This research study was designed to determine the effects of functional electrical stimulation (FES) rowing and a drug called zoledronic acid in bone health in individuals who have suffered a spinal cord injury (SCI). The investigators hoped to learn if zoledronic acid treatment would increase bone mineral density in persons with chronic spinal cord injury. This was designed and conducted as a three center study with multiple investigators. The investigators also had a goal to find out if zoledronic acid is safe for persons with SCI without causing too many side effects.
The Prime recipient of funding is Spaulding Rehabilitation Hospital (SRH). Dr. Leslie Morse is the Principal Investigator for the study, the coordination of the study was located at Spaulding Rehabilitation Hospital. Through a sub-award a research group from the Veterans Administration of Boston Healthcare System was contracted to conduct DXA scans, blood draws and zoledronic acid administration to support this study. Through another sub-award from SRH, another Investigator from Massachusetts General Hospital (MGH) participated conducting CT scans for the study. All adverse events related to this study were to be monitored and recorded by investigators at SRH.
Seventy subjects age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were enrolled. Enrollment and initial screening for the study and follow up was performed at SRH. After enrollment the subjects were randomized to 1) FES-rowing alone or 2) FES-rowing plus a 1-time infusion of zoledronic acid. Following a variable period of strength training which was necessary for preparing quads and hamstrings for extended FES use, enrolled participants were planned to begin a regular rowing program for 12 months at the Cardiovascular Laboratory at the Spaulding Rehabilitation Hospital . DXA scans to measure bone mineral density were planned to be performed at the VA Boston Healthcare System-Jamaica Plain Campus (VABHS) three times during the study on all participants. In addition, 25 subjects in each arm of the study were planned to receive CT scans of their knees at MGH at the beginning and end of the study. Up to 20 subjects were to have an additional CT scan (at MGH) six months into rowing. Research blood samples were planned to be collected at VABHS five times during duration of the study and stored at the VA for further study of molecular markers of bone turnover. All participants were expected to be screened for renal function and calcium and vitamin D levels at the beginning and end of the study, with additional renal screening done before and after the zoledronic acid infusion. Calcium and vitamin D supplements were to be provided to each subject throughout the study. Those with insufficient vitamin D levels were to be provided additional repletion and planned to be periodically rechecked. Up to 15 male subjects were asked to have two echocardiograms at one of the SRH sites - one at the beginning of the study and the other halfway through the year-long rowing regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FES Rowing | Active Comparator | Group 1 - FES-Rowing Exercise for entire study period |
|
| FES Rowing + Zoledronic acid | Experimental | Group 2 - FES-Rowing Exercise for entire study period plus Zoledronic Acid 5mg administered by i.v. infusion one-time at the end of observation period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FES-Rowing | Other | FES- Rowing Exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Bone Mass as Measured by Sequential Evaluation of Bone Density and Bone Structure | This work was designed to determine if FES-rowing plus Zoledronic acid is superior to FES-rowing alone reversing deterioration and weakening of the bones due to SCI and was planned to confirm the effects of FES-rowing in bone structure in patients not receiving Zoledronic Acid. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Validation of DXA Scanning in Patients With SCI | This study has been designed to evaluate whether sequential DXA scanning of the distal femur and proximal femur is an appropriate clinical tool to monitor bone changes in response to either treatment. Evaluation of bone density by DXA was planned to be compared to CT scans of the distal femur and proximal tibia. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
These criteria will be reviewed by telephone survey followed by a health exam where blood pressure will be assessed and a skin and neurological exam performed.
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Morse, DO | Spaulding Rehab. Hospital | Principal Investigator |
| Antonio A Lazzari, MD | Boston Division VAMC - New England | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston VAMC | Boston | Massachusetts | 02130 | United States | ||
| Spaulding Rehab. Hospital |
The study has been closed by the VABHS IRB.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rowing Arm | Prior to FES-row, subjects undertook a 2 -12 weeks strength-training program at SRH, depending on how the subjects respond to the FES-strength training. Subjects who completed strength training, progressed to rowing. In the FES-Rowing program, the goal was for each subject to achieve an exercise intensity of 75-85% maintained for a continuous 40 minutes performed 3 times each week in additional to maintaining strength training at home on days when they are not rowing. All subjects received a daily minimum supplementation of 1000mg Calcium & 1000 IUs of Vitamin-D supplementation during the duration of the program. |
| FG001 | ZA Infusion Arm | Prior to FES-row, subjects undertook a 2 -12 weeks strength-training program at SRH, depending on how the subjects respond to the FES-strength training. Subjects who completed strength training, progressed to rowing. In the FES-Rowing program, the goal was for each subject to achieve an exercise intensity of 75-85% maintained for a continuous 40 minutes performed 3 times each week in additional to maintaining strength training at home on days when they are not rowing. After the observation period, subjects in the FES rowing plus zoledronic acid arm were planned to receive Zoledronic Acid (Reclast ®) administered as a dose of 5mg intravenously. All subjects received a daily minimum supplementation of 1000mg Calcium & 1000 IUs of Vitamin-D supplementation during the duration of the program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ZA Infusion Arm | Thirty five subjects in each arm, age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were enrolled. |
| BG001 | Rowing Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Improvement of Bone Mass as Measured by Sequential Evaluation of Bone Density and Bone Structure | This work was designed to determine if FES-rowing plus Zoledronic acid is superior to FES-rowing alone reversing deterioration and weakening of the bones due to SCI and was planned to confirm the effects of FES-rowing in bone structure in patients not receiving Zoledronic Acid. | Data was never analyzed because the study was closed by the VABHS IRB. Full dataset is unavailable for analysis. | Posted | 12 months |
|
Participants were followed up for the duration of the study for up to 4 years.
Adverse Events data not complete on participants to the IND Sponsor.
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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 | ZA Infusion Arm | No adverse event data were available for the remaining 9 participants. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| UTI | Renal and urinary disorders | UTI | Non-systematic Assessment | Hospitalized for UTI unrelated to rowing. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spasticity | Musculoskeletal and connective tissue disorders | Spasms | Systematic Assessment | Spasms or contractions. |
No Data Safety Monitor Board established for this project. Incomplete data set and analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Antonio Lazzari | VA Boston Healthcare System | 857-364-6381 | antonio.lazzari@va.gov |
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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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| OTHER |
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| Zoledronic acid | Drug | 5 mg IV single dose |
|
|
| Charlestown |
| Massachusetts |
| 02129 |
| United States |
Thirty five subjects, in each arm age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were enrolled.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Rowing Arm |
Thirty Five subjects, in each arm age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were planned to be enrolled. No Data was analyzed because dataset is not available to VABHS Study team. |
|
| Secondary | Validation of DXA Scanning in Patients With SCI | This study has been designed to evaluate whether sequential DXA scanning of the distal femur and proximal femur is an appropriate clinical tool to monitor bone changes in response to either treatment. Evaluation of bone density by DXA was planned to be compared to CT scans of the distal femur and proximal tibia. | Dataset unavailable for analysis to VABHS study team. The study was closed by the VABHS IRB. | Posted | 12 months |
|
|
| 6 |
| 26 |
| 15 |
| 26 |
| EG001 | Rowing Arm | No adverse event data were available for the remaining 16 participants. | 6 | 19 | 15 | 19 |
|
| Kidney Stone | Renal and urinary disorders | Kidney Stone | Non-systematic Assessment | Kidney stone |
|
| Fracture | Musculoskeletal and connective tissue disorders | Fracture | Non-systematic Assessment | Fractured bone. Patient withdrew from the study before underdoing study procedures. |
|
| Upper Respiratory Tract Infection | Infections and infestations | URI | Non-systematic Assessment | Subject developed a Upper Respiratory Tract Infection |
|
| Elevated Heart Rate | Cardiac disorders | Tachycardia | Non-systematic Assessment |
|
| High Fever | Infections and infestations | High Fever | Systematic Assessment | High Fever, vomiting, chills and fatigue. |
|
| Pressure Ulcers | Skin and subcutaneous tissue disorders | Pressure Ulcer | Non-systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | Cellulitis | Non-systematic Assessment |
|
|
| Fatigue / Not Feeling Well / Asthenia | General disorders | Fatigue / Asthenia | Systematic Assessment | Fatigue, Not Feeling Well, Asthenia, Dizziness |
|
| Injury / Skin Cuts | Injury, poisoning and procedural complications | Injury | Systematic Assessment | Injury, skin cuts, bruises |
|
| Fracture | Musculoskeletal and connective tissue disorders | Fracture | Systematic Assessment | Fracture |
|
| Blood Pressure | Cardiac disorders | Blood Pressure | Systematic Assessment | High Blood Pressure Low Blood Pressure |
|
| Gastrointestinal Disorders | Gastrointestinal disorders | GI Disorder | Systematic Assessment | gastroenteritis, stomach pain, constipation or diarrhea. |
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| Cardiac Conditions / Arrhythmias | Cardiac disorders | Cardia Disorder | Systematic Assessment | Fast heart rate, atrial fibrillation, arrhythmias |
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| Respiratory Illness/Disorder | Respiratory, thoracic and mediastinal disorders | Respiratory Disorder | Systematic Assessment | Respiratory Illness/Disorder, Bronchitis, Upper respiratory infection, Flu symptoms |
|
| Pain / Aches / Neuralgia | Musculoskeletal and connective tissue disorders | Aches and Pain | Systematic Assessment | Aches Pain Neuralgia including musculoskeletal pains |
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| Fever | General disorders | Fever / Chills | Systematic Assessment | fever, chills |
|
| Falls / Injuries | Injury, poisoning and procedural complications | Falls or Injuries | Systematic Assessment | fall or injury car accident with injury |
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| Pressure Ulcer / Sore | Skin and subcutaneous tissue disorders | Pressure Ulcer | Systematic Assessment | Pressure Ulcer / Sore Decubitus Ulcer |
|
| Urinary Tract Infection | Renal and urinary disorders | Urinary Tract Infect | Systematic Assessment | urinary tract infections |
|
| Autonomic Dysreflexia / Other General Symptoms | General disorders | Autonomic Dysreflexi | Systematic Assessment | autonomic dysreflexia, other general symptoms |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |