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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose of this study is to determine if a second year of exposure to teriparatide in both subjects that received a year of teriparatide or teriparatide-placebo will result in a greater increase in bone mass density (BMD) compared to that seen in a single year's treatment.
This study will also investigate 1) if a second year of teriparatide therapy will increase bone strength in people with chronic spinal cord injury (SCI) who previously received a year of teriparatide or teriparatide-placebo, 2) the number of participants with adverse events from teriparatide, and 3) the effects of teriparatide on serum markers of bone metabolism.
This extension study will only enroll individuals who have completed one year of treatment in the parent protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury (NCT01225055)". This study will allow those individuals who received Teriparatide (20ug/day) and vibration (10 min/day) during the parent study to be treated for a second year and will allow those individuals who received teriparatide-placebo to have the opportunity to have a full year of teriparatide therapy. This study will determine if two years of exposure to teriparatide will result in a greater increase in Bone Mass Density (BMD) than that seen after a single year's treatment. Subjects will be evaluated at 6 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 and vibration | Experimental | Experimental: Teriparatide and vibration Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months Device: Vibration 10 min/day for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | Teriparatide 20 ug daily Sub-Q over 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA) | The mean percent change in BMD of the total hip after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179). | Baseline to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| C-terminal Telopeptide | The mean percent change in C-terminal telopeptide from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179). |
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Inclusion Criteria:
Enrollment in, and completion of one year of treatment, in protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury".
Adherence rate for teriparatide use of ≥60%.
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Ability to understand and the willingness to sign a written informed consent.
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 |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Teriparatide | Experimental: Teriparatide and vibration Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months Device: Vibration 10 min/day for 12 months Completed in previously enrolled study (STU00033380), Teriparatide alone with sham vibration Teriparatide: 20 ug daily over 12 months |
| FG001 | Vibration | Experimental: Teriparatide and vibration Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months Device: Vibration 10 min/day for 12 months Completed in previously enrolled study (STU00033380), Vibration alone with placebo-teriparatide vibration: 10 min/day for 12 months |
| FG002 | Teriparatide and Vibration | Experimental: Teriparatide and vibration Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months Device: Vibration 10 min/day for 12 months Completed in previously enrolled study (STU00033380), Teriparatide with vibration applied in conjunction 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 | Experimental: Teriparatide and vibration Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months Device: Vibration 10 min/day for 12 months Completed in previously enrolled study (STU00033380), Teriparatide alone with sham vibration Teriparatide: 20 ug daily over 12 months |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Dual-energy X-ray Absorptiometry (DXA) | The mean percent change in BMD of the total hip after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179). | One subject in "Teriparatide and vibration" group was lost to follow-up | Posted | Mean | 95% Confidence Interval | Percent change | Baseline to 24 months |
|
12 months
One subject in "Teriparatide and vibration" group was lost to follow-up. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section.
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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 | Experimental: Teriparatide and vibration Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months Device: Vibration 10 min/day for 12 months Completed in previously enrolled study (STU00033380), Teriparatide alone with sham vibration Teriparatide: 20 ug daily over 12 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | 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 |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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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 | Vibration 10 min/day for 12 months |
|
|
| Baseline to 24 Months |
| Bone Mineral Density (BMD) by DXA at the Lumbar Spine | The mean percent change in BMD at the lumbar spine from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179). | Baseline to 24 Months |
| Bone Mineral Density (BMD) by DXA at Femoral Neck | The mean percent change in BMD of the femoral neck after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179). | Baseline to 24 Months |
| Amino-terminal Propeptide of Type 1 Collagen | The mean percent change in Amino-terminal of type 1 collagen from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179). | Baseline to 24 Months |
| Bone-specific Alkaline Phosphatase | The mean percent change in Bone-specific alkaline phosphatase from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179). | Baseline to 24 Months |
| Vibration |
Experimental: Teriparatide and vibration Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months Device: Vibration 10 min/day for 12 months Completed in previously enrolled study (STU00033380), Vibration alone with placebo-teriparatide vibration: 10 min/day for 12 months |
| BG002 | Teriparatide and Vibration | Experimental: Teriparatide and vibration Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months Device: Vibration 10 min/day for 12 months Completed in previously enrolled study (STU00033380), Teriparatide with vibration applied in conjunction Teriparatide: 20 ug daily over 12 months vibration: 10 min/day for 12 months |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| American Spinal Injury Association (ASIA) Impairment Scale | ASIA impairment scale describes a person's functional impairment as a result of their spinal cord injury. A = Complete. No motor or sensory function in the lowest sacral spine segment (S4-5). B = Sensory Incomplete. Sensory function below the neurological level of injury (NLI) and in S4-S5, no motor function below NLI. C = Motor Incomplete. Motor function is preserved below NLI and more than half of the key muscle groups below NLI have a muscle grade < 3. D = Motor Incomplete. Motor function is preserved below NLI and at least half of the key muscle groups below NLI have a muscle grade 3. | Count of Participants | Participants |
|
Experimental: Teriparatide and vibration
Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months
Device: Vibration 10 min/day for 12 months
Completed in previously enrolled study (STU00033380),
Teriparatide alone with sham vibration
Teriparatide: 20 ug daily over 12 months
| OG001 | Vibration | Experimental: Teriparatide and vibration Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months Device: Vibration 10 min/day for 12 months Completed in previously enrolled study (STU00033380), Vibration alone with placebo-teriparatide vibration: 10 min/day for 12 months |
| OG002 | Teriparatide and Vibration | Experimental: Teriparatide and vibration Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months Device: Vibration 10 min/day for 12 months Completed in previously enrolled study (STU00033380), Teriparatide with vibration applied in conjunction Teriparatide: 20 ug daily over 12 months vibration: 10 min/day for 12 months |
|
|
| Secondary | C-terminal Telopeptide | The mean percent change in C-terminal telopeptide from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179). | One subject in "Teriparatide and vibration" group was lost to follow-up | Posted | Mean | 95% Confidence Interval | Percent change | Baseline to 24 Months |
|
|
|
| Secondary | Bone Mineral Density (BMD) by DXA at the Lumbar Spine | The mean percent change in BMD at the lumbar spine from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179). | One subject in "Teriparatide and vibration" group was lost to follow-up. Another subject in "Teriparatide and vibration" spine could not be analyzed due to a baclofen pump. | Posted | Mean | 95% Confidence Interval | Percent change | Baseline to 24 Months |
|
|
|
| Secondary | Bone Mineral Density (BMD) by DXA at Femoral Neck | The mean percent change in BMD of the femoral neck after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179). | One subject in "Teriparatide and vibration" group was lost to follow-up | Posted | Mean | 95% Confidence Interval | Percent change | Baseline to 24 Months |
|
|
|
| Secondary | Amino-terminal Propeptide of Type 1 Collagen | The mean percent change in Amino-terminal of type 1 collagen from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179). | One subject in "Teriparatide and vibration" group was lost to follow-up | Posted | Mean | 95% Confidence Interval | Percent change | Baseline to 24 Months |
|
|
|
| Secondary | Bone-specific Alkaline Phosphatase | The mean percent change in Bone-specific alkaline phosphatase from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179). | One subject in "Teriparatide and vibration" group was lost to follow-up | Posted | Mean | 95% Confidence Interval | Percent change | Baseline to 24 Months |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 5 |
| 8 |
| EG001 | Vibration | Experimental: Teriparatide and vibration Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months Device: Vibration 10 min/day for 12 months Completed in previously enrolled study (STU00033380), Vibration alone with placebo-teriparatide vibration: 10 min/day for 12 months | 0 | 9 | 1 | 9 | 7 | 9 |
| EG002 | Teriparatide and Vibration | Experimental: Teriparatide and vibration Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months Device: Vibration 10 min/day for 12 months Completed in previously enrolled study (STU00033380), Teriparatide with vibration applied in conjunction Teriparatide: 20 ug daily over 12 months vibration: 10 min/day for 12 months | 0 | 7 | 2 | 7 | 5 | 7 |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Dehydration | General disorders | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | Systematic Assessment |
|
| Kidney Stone | Renal and urinary disorders | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Allergic Reaction | Immune system disorders | Systematic Assessment |
|
| Allergies | Immune system disorders | Systematic Assessment |
|
| Burn | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cold/Flu | Infections and infestations | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Cut | Injury, poisoning and procedural complications | Systematic Assessment | Cut Tip of Left Thumb |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Dry scalp | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fall | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Hyponatremia | Renal and urinary disorders | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
|
| Lower extremity fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pinched nerve | Nervous system disorders | Systematic Assessment |
|
| Pressure sore | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Toe wound | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |