- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02025179
12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI)
12 Month Open-Label Extension Study of the Effect of Teriparatide on Bone in People With Chronic SCI
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University Feinberg School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 |
Teriparatide 20 ug daily Sub-Q over 12 months
Other Names:
Vibration 10 min/day for 12 months
Other Names:
|
What is the study measuring?
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)
Time Frame: Baseline to 24 months
|
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
Time Frame: Baseline to 24 Months
|
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
Time Frame: Baseline to 24 Months
|
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
Time Frame: Baseline to 24 Months
|
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
Time Frame: Baseline to 24 Months
|
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
Time Frame: Baseline to 24 Months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas J Schnitzer, MD, PhD, Northwestern University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Nervous System Diseases
- Central Nervous System Diseases
- Vibration
- Musculoskeletal Diseases
- Spinal Cord Injury
- Osteoporosis
- Physiological Effects of Drugs
- Bone Diseases
- Pharmacologic Actions
- Teriparatide
- Metabolic Bone Diseases
- Spinal Cord Diseases
- Nervous System
- Wounds and Injuries
- Bone Density Conservation Agents
Additional Relevant MeSH Terms
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Musculoskeletal Diseases
- Trauma, Nervous System
- Spinal Cord Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Wounds and Injuries
- Osteoporosis
- Spinal Cord Injuries
- Physiological Effects of Drugs
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Teriparatide
Other Study ID Numbers
- A1195
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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