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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02025179

Enrollment

Registered

2013-12-31

Start date

2013-01-31

Completion date

2015-08-14

Last updated

2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Loss, Osteoporosis, Spinal Cord Injury

Keywords

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, Pharmacologic Actions, Vibration

Brief summary

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

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.

Interventions

DRUGTeriparatide

Teriparatide 20 ug daily Sub-Q over 12 months

DEVICEVibration

Vibration 10 min/day for 12 months

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
C-terminal Telopeptide	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).
Bone Mineral Density (BMD) by DXA at the Lumbar Spine	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).
Bone Mineral Density (BMD) by DXA at Femoral Neck	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).
Amino-terminal Propeptide of Type 1 Collagen	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).
Bone-specific Alkaline Phosphatase	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).

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	8
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	9
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	8
Total	25

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	0	0	1

Baseline characteristics

Characteristic	Total	Teriparatide and Vibration	Vibration	Teriparatide
Age, Continuous	40.5 years	41.7 years	38.0 years	42.2 years
American Spinal Injury Association (ASIA) Impairment Scale ASIA A (Complete Injury)	19 Participants	7 Participants	8 Participants	4 Participants
American Spinal Injury Association (ASIA) Impairment Scale ASIA B (Sensory Incomplete Injury)	2 Participants	1 Participants	0 Participants	1 Participants
American Spinal Injury Association (ASIA) Impairment Scale ASIA C (Motor Incomplete Injury)	4 Participants	0 Participants	1 Participants	3 Participants
American Spinal Injury Association (ASIA) Impairment Scale ASIA D (Motor Incomplete Injury)	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants	1 Participants	2 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants	7 Participants	7 Participants	6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	0 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	13 Participants	5 Participants	5 Participants	3 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants	0 Participants	1 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	10 Participants	3 Participants	2 Participants	5 Participants
Sex: Female, Male Female	7 Participants	3 Participants	2 Participants	2 Participants
Sex: Female, Male Male	18 Participants	5 Participants	7 Participants	6 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 8	0 / 9	0 / 7
other Total, other adverse events	5 / 8	7 / 9	5 / 7
serious Total, serious adverse events	0 / 8	1 / 9	2 / 7

Outcome results

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).

Time frame: Baseline to 24 months

Population: One subject in Teriparatide and vibration group was lost to follow-up

Arm	Measure	Value (MEAN)
Teriparatide	Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA)	6.73 Percent change
Vibration	Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA)	-0.34 Percent change
Teriparatide and Vibration	Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA)	4.24 Percent change

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).