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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-SC090010 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| Edward Hines Jr. VA Hospital | FED |
| University of Illinois at Chicago | OTHER |
| Congressionally Directed Medical Research Programs | FED |
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Spinal cord injury (SCI) results in marked acute loss of bone. This study evaluates the effect of teriparatide (PTH) and the use of vibration as a form of mechanical stimulation on bone mass.
The aim of this study is to evaluate PTH with vibration in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 60 subjects with SCI will be enrolled into a 12 month study assessing the effects of PTH (20 ug/day) and vibration (10 min/day) individually or in combination on BMD and bone markers. Subjects will be evaluated at 3, 6, 9, and 12 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teriparatide | Experimental | Teriparatide alone with sham vibration |
|
| Vibration | Experimental | Vibration alone with placebo-teriparatide |
|
| Teriparatide and vibration | Experimental | Teriparatide with vibration applied in conjuction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | 20 ug daily over 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density BMD of the Total Hip as Assessed by DXA. | The mean change in BMD of the total hip after 12 month of treatment | Baseline to 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density (BMD) by DXA at the Lumbar Spine. | The mean change in BMD at the lumbar spine from baseline after 12 month of treatment | Baseline to 12 Months |
| Bone Mineral Density (BMD) by DXA at Femoral Neck |
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Inclusion Criteria:
Age >21 years (must have closed epiphyses; PTH contraindicated if epiphyses open)
Exclusion Criteria:
Surgical or other intervention resulting in metal or anatomy precluding obtaining DXA measurements (e.g., cardiac pacemakers, ferromagnetic implants or brain aneurysm clips).
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| Name | Affiliation | Role |
|---|---|---|
| Thomas J Schnizter, MD, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States | ||
| Edward Hines, Jr, VA Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30334093 | Derived | Haider IT, Lobos SM, Simonian N, Schnitzer TJ, Edwards WB. Bone fragility after spinal cord injury: reductions in stiffness and bone mineral at the distal femur and proximal tibia as a function of time. Osteoporos Int. 2018 Dec;29(12):2703-2715. doi: 10.1007/s00198-018-4733-0. Epub 2018 Oct 17. |
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One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. After consenting the subject did not participate in the study.. This accounts for the 61 in Participant Flow but 60 that were enrolled and started treatment according to their assigned group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Teriparatide | Teriparatide alone with sham vibration Teriparatide: 20 ug daily over 12 months |
| FG001 | Vibration | Vibration alone with placebo-teriparatide vibration: 10 min/day for 12 months |
| FG002 | Teriparatide and Vibration | Teriparatide with vibration applied in conjuction Teriparatide: 20 ug daily over 12 months vibration: 10 min/day for 12 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Teriparatide | Teriparatide alone with sham vibration Teriparatide: 20 ug daily over 12 months |
| BG001 | Vibration | Vibration alone with placebo-teriparatide vibration: 10 min/day for 12 months |
| 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 | Bone Mineral Density BMD of the Total Hip as Assessed by DXA. | The mean change in BMD of the total hip after 12 month of treatment | One subject withdrew prior to receiving therapy. The samples from the Hines location (n=11) were also not included. Two additional subjects were not analyzed due to metal artifacts or heterotopic ossification that interfered with analysis. This accounts for the 14 subjects that were not analyzed. | Posted | Mean | Standard Deviation | g/cm^2 | Baseline to 12 Months |
|
Baseline to 12 months
One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
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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 | Teriparatide | Teriparatide alone with sham vibration Teriparatide: 20 ug daily over 12 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular Event | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acid Reflux | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Schnitzer | Northwestern University | 312-503-2315 | tjs@northwestern.edu |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D001851 | Bone Diseases, Metabolic |
| 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 |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| vibration | Device | 10 min/day for 12 months |
|
The mean change in BMD of the femoral neck after 12 month of treatment
| Baseline to 12 Months |
| C-terminal Telopeptide | The mean change in C-terminal telopeptide from baseline after 12 month of treatment | Baseline to 12 Months |
| Bone-specific Alkaline Phosphatase | The mean change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy | Baseline to 12 Months |
| Amino-terminal Propeptide of Type 1 Collagen | The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment | Baseline to 12 Months |
| Maywood |
| Illinois |
| 60153 |
| United States |
| BG002 | Teriparatide and Vibration | Teriparatide with vibration applied in conjuction Teriparatide: 20 ug daily over 12 months vibration: 10 min/day for 12 months |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Teriparatide and Vibration | Teriparatide with vibration applied in conjuction Teriparatide: 20 ug daily over 12 months vibration: 10 min/day for 12 months |
|
|
|
| Secondary | Bone Mineral Density (BMD) by DXA at the Lumbar Spine. | The mean change in BMD at the lumbar spine from baseline after 12 month of treatment | One subject withdrew prior to receiving therapy. The samples from the Hines location (n=11) were also not included. Five additional subjects were not analyzed due to metal artifacts that interfered with analysis. This accounts for the 17 subjects that were not analyzed. | Posted | Mean | Standard Deviation | g/cm^2 | Baseline to 12 Months |
|
|
|
|
| Secondary | Bone Mineral Density (BMD) by DXA at Femoral Neck | The mean change in BMD of the femoral neck after 12 month of treatment | One subject withdrew prior to receiving therapy. The samples from the Hines location (n=11) were also not included. One additional subjects was not analyzed due to metal artifacts or heterotopic ossification that interfered with analysis. This accounts for the 13 subjects that were not analyzed. | Posted | Mean | Standard Deviation | g/cm^2 | Baseline to 12 Months |
|
|
|
|
| Secondary | C-terminal Telopeptide | The mean change in C-terminal telopeptide from baseline after 12 month of treatment | One subject withdrew prior to receiving therapy from the Teriparatide and Vibration group. One sample was lost due to laboratory error. The samples from the Hines location (n=11) were also not included in this analysis. This accounts for the 13 subjects that were not analyzed. | Posted | Mean | Standard Deviation | ng/ml | Baseline to 12 Months |
|
|
|
|
| Secondary | Bone-specific Alkaline Phosphatase | The mean change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy | One subject withdrew prior to receiving therapy from the Teriparatide and Vibration group. One sample was lost due to laboratory error. The samples from the Hines location (n=11) were also not included in this analysis. This accounts for the 13 subjects that were not analyzed. | Posted | Mean | Standard Deviation | ng/ml | Baseline to 12 Months |
|
|
|
|
| Secondary | Amino-terminal Propeptide of Type 1 Collagen | The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment | One subject withdrew prior to receiving therapy from the Teriparatide and Vibration group. One sample was lost due to laboratory error. The samples from the Hines location (n=11) were also not included in this analysis. This accounts for the 13 subjects that were not analyzed. | Posted | Mean | Standard Deviation | ng/ml | Baseline to 12 Months |
|
|
|
|
| 0 |
| 20 |
| 7 |
| 20 |
| 16 |
| 20 |
| EG001 | Vibration | Vibration alone with placebo-teriparatide vibration: 10 min/day for 12 months | 0 | 20 | 1 | 20 | 16 | 20 |
| EG002 | Teriparatide and Vibration | Teriparatide with vibration applied in conjuction Teriparatide: 20 ug daily over 12 months vibration: 10 min/day for 12 months | 0 | 20 | 8 | 20 | 16 | 20 |
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Lower extremity fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pneumonia and respiratory distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Soft tissue infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Bleeding, bruising or irritation at injection site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Burns | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Flu like symptoms | Infections and infestations | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Increased Nerve Pain | Nervous system disorders | Non-systematic Assessment |
|
| Increased spasticity | Nervous system disorders | Non-systematic Assessment |
|
| Indigestion | Gastrointestinal disorders | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Lower extremity fractures | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lower extremity pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Nausea/Vomitting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Parageusia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Parathesias | Nervous system disorders | Non-systematic Assessment |
|
| Pressure sore | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
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| D014947 | Wounds and Injuries |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
|
| 6 months |
|
| 12 months |
|
Repeated measures ANOVA |
| 0.00 |
calculated p-value indicating the effect of different time points |
| Superiority |
| ANOVA | Repeated measures ANOVA | 0.09 | calculated p-value indicating the effect of different treatment groups and time points | Superiority |
|
| 6 months |
|
| 12 months |
|
Repeated measures ANOVA |
| 0.58 |
calculated p-value indicating the effect of different time points |
| Superiority |
| ANOVA | Repeated measures ANOVA | 0.44 | calculated p-value indicating the effect of different treatment groups and time points | Superiority |
|
| 6 months |
|
| 12 months |
|
Repeated measures ANOVA |
| 0.10 |
calculated p-value indicating the effect of different time points |
| Superiority |
| ANOVA | Repeated measures ANOVA | 0.04 | calculated p-value indicating the effect of different treatment groups and time points | Superiority |
|
| 6 months |
|
| 12 months |
|
Repeated measures ANOVA |
| 0.34 |
calculated p-value indicating the effect of different time points |
| Superiority |
| ANOVA | Repeated measures ANOVA | 0.20 | calculated p-value indicating the effect of different treatment groups and time points | Superiority |
|
| 6 months |
|
| 12 months |
|
Repeated measures ANOVA |
| 0.01 |
calculated p-value indicating the effect of different time points |
| Superiority |
| ANOVA | Repeated measures ANOVA | 0.04 | calculated p-value indicating the effect of different treatment groups and time points | Superiority |