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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT02025179 (opens ClinicalTrials.gov in a new tab)Other idA1195
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
25 participants (actual)
Sponsor
Northwestern University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jan 2013
Primary completion
14 Aug 2015
Completion
14 Aug 2015
First posted
31 Dec 2013 (estimated)
Last update posted
10 May 2023
Conditions
Spinal Cord Injury · Bone Loss · Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 2

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

    NCT02025179

    Jan 2013 to 14 Aug 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TeriparatideDrug
  • VibrationDevice

Arms1

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA)

    Time frame · Baseline to 24 months

    Registry description

    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).

Secondary outcomes(5)

  1. C-terminal Telopeptide

    Time frame · Baseline to 24 Months

    Registry description

    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).

  2. Bone Mineral Density (BMD) by DXA at the Lumbar Spine

    Time frame · Baseline to 24 Months

    Registry description

    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).

  3. Bone Mineral Density (BMD) by DXA at Femoral Neck

    Time frame · Baseline to 24 Months

    Registry description

    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).

  4. Amino-terminal Propeptide of Type 1 Collagen

    Time frame · Baseline to 24 Months

    Registry description

    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).

  5. Bone-specific Alkaline Phosphatase

    Time frame · Baseline to 24 Months

    Registry description

    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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline to 24 months

Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA)

GroupValue (Percent change)
Teriparatide6.73
Vibration-0.34
Teriparatide and Vibration4.24
Secondary and other outcome results(5)
Secondary outcomeMean· Baseline to 24 Months

C-terminal Telopeptide

GroupValue (Percent change)
Teriparatide-19.8
Vibration-14.8
Teriparatide and Vibration-2.12
Secondary outcomeMean· Baseline to 24 Months

Bone Mineral Density (BMD) by DXA at the Lumbar Spine

GroupValue (Percent change)
Teriparatide14.4
Vibration7.05
Teriparatide and Vibration8.98
Secondary outcomeMean· Baseline to 24 Months

Bone Mineral Density (BMD) by DXA at Femoral Neck

GroupValue (Percent change)
Teriparatide2.73
Vibration-0.06
Teriparatide and Vibration4.71
Secondary outcomeMean· Baseline to 24 Months

Amino-terminal Propeptide of Type 1 Collagen

GroupValue (Percent change)
Teriparatide102
Vibration104
Teriparatide and Vibration58
Secondary outcomeMean· Baseline to 24 Months

Bone-specific Alkaline Phosphatase

GroupValue (Percent change)
Teriparatide11.5
Vibration12.6
Teriparatide and Vibration10.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
TeriparatideExperimental: 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 months0 / 80 / 85 / 8
VibrationExperimental: 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 months0 / 91 / 97 / 9
Teriparatide and VibrationExperimental: 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 months0 / 72 / 75 / 7

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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