12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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12 Month Open-Label Extension Study of the Effect of Teriparatide on Bone in People With Chronic SCI

Conditions
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Spinal Cord Injury, Bone Loss, Osteoporosis

Intervention / Treatment
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* Drug: Teriparatide
* Device: Vibration


Participation Criteria
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Eligibility Criteria
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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: Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: Individuals who could not tolerate teriparatide treatment. Individuals who will not be able to return for all study visits. Patients may not be receiving any other investigational agents. Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teriparatide and vibration<br>Experimental: Teriparatide and vibration Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months Device: Vibration 10 min/day for 12 months | Drug: Teriparatide<br>* Teriparatide 20 ug daily Sub-Q over 12 months<br>* Other names: Forteo;Device: Vibration<br>* Vibration 10 min/day for 12 months<br>* Other names: Soloflex Whole Body Vibration platform;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacologic Actions, Teriparatide, Osteoporosis, Spinal Cord Injury, Bone Diseases, Metabolic Bone Diseases, Musculoskeletal Diseases, Spinal Cord Diseases, Central Nervous System Diseases, Nervous System Diseases, Nervous System, Wounds and Injuries, Bone Density Conservation Agents, Physiological Effects of Drugs, Vibration