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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
| Shirley Ryan AbilityLab | OTHER |
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Individuals with spinal cord injury sustain significant loss of bone mass in their lower extremities (20-40% or more). This study evaluates the ability of PTH and weight-bearing, two interventions that build bone, to increase bone mass in this population.
This pilot project aims to evaluate PTH with weight-bearing in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 12 people with SCI will be enrolled into a 6 month study assessing the effects of a weight-bearing regime plus daily PTH (Forteo 20ug sc) on BMD and bone markers. Subjects will be evaluated at 3 and 6 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption. An optional extension to 12 months will be offered to all subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTH/Weight-Bearing | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teriparatide | Drug | teriparatide 20ug daily sc for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| BMD at Left Total Hip | Bone mineral density (gm/cm2) of the total hip region of interest on the left | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| P1NP | amino-terminal propeptide of type I collagen (P1NP) | Baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas J Schnitzer, MD, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Institute of Chicago | Chicago | Illinois | 60611 | United States |
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Recruitment from outpatient clinic at rehab hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | PTH/Weight-Bearing | PTH 20ug/day plus assisted weight-bearing on a Lokomat |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PTH/Weight-Bearing | PTH 20ug/day plus assisted weight-bearing of one hour 3x/week |
| 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 | BMD at Left Total Hip | Bone mineral density (gm/cm2) of the total hip region of interest on the left | Posted | Mean | Standard Deviation | % change in BMD (gm/cm2) from baseline | Baseline to 6 months |
|
|
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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 | PTH/Weight-Bearing | PTH 20ug/day plus assisted weight-bearing of one hour 3x/week |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Small numbers of subjects analyzed with considerable between-subject variability.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas J Schnitzer | Northwestern University Feinberg School of Medicine | 3125032315 | tjs@northwestern.edu |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| D016474 | Weight-Bearing |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| weight-bearing | Other | device assisted walking |
|
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | P1NP | amino-terminal propeptide of type I collagen (P1NP) | Only 8 of the total 12 participants enrolled had serum available for testing | Posted | Mean | Standard Deviation | % change from baseline | Baseline to 6 months |
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|
|
| 0 |
| 12 |
| 1 |
| 12 |
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| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |