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

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02025179
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 25
• Location: 1
• Arm: 1
• Actual Duration (Months): 31.4
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury; Bone Loss; Osteoporosis	Drug: Teriparatide; Device: Vibration	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 12 Month Open-Label Extension Study of the Effect of Teriparatide on Bone in People With Chronic SCI
• Actual Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Aug 14, 2015
• Actual Study Completion Date: Aug 14, 2015

Arms and Interventions

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	Drug: Teriparatide; Teriparatide 20 ug daily Sub-Q over 12 months; Other Names: Forteo ; Device: Vibration; Vibration 10 min/day for 12 months; Other Names: Soloflex Whole Body Vibration platform

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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).

2. 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).

3. 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).

4. 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).

5. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• United States Department of Defense

Investigators

• Principal Investigator: Thomas J Schnitzer, MD, PhD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas J. Schnitzer, Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT02025179
• Other Study ID Numbers: A1195
• First Posted: Dec 31, 2013
• Last Update Posted: Sep 25, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Thomas J. Schnitzer, Professor, Northwestern University: 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
• Additional relevant MeSH terms: Osteoporosis; Spinal Cord Injuries; Wounds and Injuries; Teriparatide

Study Results

Participant Flow

Arm/Group Title	Teriparatide	Vibration	Teriparatide and Vibration
Arm/Group Description	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	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	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
Period Title: Overall Study
STARTED	8	9	8
COMPLETED	8	9	7
NOT COMPLETED	0	0	1

Baseline Characteristics

Arm/Group Title	Teriparatide	Vibration	Teriparatide and Vibration	Total
Arm/Group Description	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	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	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	Total of all reporting groups
Overall Participants	8	9	8	25
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	42.2	38.0	41.7	40.5
Sex: Female, Male (Count of Participants)
Female	2 25%	2 22.2%	3 37.5%	7 28%
Male	6 75%	7 77.8%	5 62.5%	18 72%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 25%	2 22.2%	1 12.5%	5 20%
Not Hispanic or Latino	6 75%	7 77.8%	7 87.5%	20 80%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	1 11.1%	0 0%	1 4%
Native Hawaiian or Other Pacific Islander	0 0%	1 11.1%	0 0%	1 4%
Black or African American	3 37.5%	5 55.6%	5 62.5%	13 52%
White	5 62.5%	2 22.2%	3 37.5%	10 40%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
American Spinal Injury Association (ASIA) Impairment Scale (Count of Participants)
ASIA A (Complete Injury)	4 50%	8 88.9%	7 87.5%	19 76%
ASIA B (Sensory Incomplete Injury)	1 12.5%	0 0%	1 12.5%	2 8%
ASIA C (Motor Incomplete Injury)	3 37.5%	1 11.1%	0 0%	4 16%
ASIA D (Motor Incomplete Injury)	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA)
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).
Time Frame	Baseline to 24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Teriparatide	Vibration	Teriparatide and Vibration
Arm/Group Description	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	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	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
Measure Participants	8	9	7
Mean (95% Confidence Interval) [Percent change]	6.73	-0.34	4.24

2. Secondary Outcome

Title	C-terminal Telopeptide
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).
Time Frame	Baseline to 24 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Teriparatide	Vibration	Teriparatide and Vibration
Arm/Group Description	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	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	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
Measure Participants	8	9	7
Mean (95% Confidence Interval) [Percent change]	-19.8	-14.8	-2.12

3. Secondary Outcome

Title	Bone Mineral Density (BMD) by DXA at the Lumbar Spine
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).
Time Frame	Baseline to 24 Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Teriparatide	Vibration	Teriparatide and Vibration
Arm/Group Description	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	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	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
Measure Participants	8	9	6
Mean (95% Confidence Interval) [Percent change]	14.4	7.05	8.98

4. Secondary Outcome

Title	Bone Mineral Density (BMD) by DXA at Femoral Neck
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).
Time Frame	Baseline to 24 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Teriparatide	Vibration	Teriparatide and Vibration
Arm/Group Description	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	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	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
Measure Participants	8	9	7
Mean (95% Confidence Interval) [Percent change]	2.73	-0.06	4.71

5. Secondary Outcome

Title	Amino-terminal Propeptide of Type 1 Collagen
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).
Time Frame	Baseline to 24 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Teriparatide	Vibration	Teriparatide and Vibration
Arm/Group Description	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	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	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
Measure Participants	8	9	7
Mean (95% Confidence Interval) [Percent change]	102	104	58

6. Secondary Outcome

Title	Bone-specific Alkaline Phosphatase
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).
Time Frame	Baseline to 24 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Teriparatide	Vibration	Teriparatide and Vibration
Arm/Group Description	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	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	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
Measure Participants	8	9	7
Mean (95% Confidence Interval) [Percent change]	11.5	12.6	10.9

Adverse Events

Time Frame	12 months
Adverse Event Reporting Description	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.
Arm/Group Title	Teriparatide		Vibration		Teriparatide and Vibration
Arm/Group Description	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		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		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
All Cause Mortality
	Teriparatide		Vibration		Teriparatide and Vibration
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/9 (0%)		0/7 (0%)
Serious Adverse Events
	Teriparatide		Vibration		Teriparatide and Vibration
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		1/9 (11.1%)		2/7 (28.6%)
General disorders
Dehydration	0/8 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer	0/8 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1
Nervous system disorders
Paresthesia	0/8 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1
Renal and urinary disorders
Urinary Tract Infection	0/8 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	2
Kidney Stone	0/8 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0
Other (Not Including Serious) Adverse Events
	Teriparatide		Vibration		Teriparatide and Vibration
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/8 (62.5%)		7/9 (77.8%)		5/7 (71.4%)
Cardiac disorders
Hypertension	1/8 (12.5%)	1	1/9 (11.1%)	1	0/7 (0%)	0
Gastrointestinal disorders
Abdominal pain	0/8 (0%)	0	1/9 (11.1%)	1	2/7 (28.6%)	2
Constipation	1/8 (12.5%)	1	0/9 (0%)	0	1/7 (14.3%)	1
Food poisoning	1/8 (12.5%)	1	0/9 (0%)	0	0/7 (0%)	0
General disorders
Dizziness	0/8 (0%)	0	1/9 (11.1%)	1	1/7 (14.3%)	1
Fall	1/8 (12.5%)	1	0/9 (0%)	0	0/7 (0%)	0
Fatigue	0/8 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0
Immune system disorders
Allergic Reaction	1/8 (12.5%)	1	1/9 (11.1%)	1	0/7 (0%)	0
Allergies	0/8 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0
Infections and infestations
Cold/Flu	2/8 (25%)	3	2/9 (22.2%)	2	2/7 (28.6%)	3
Injury, poisoning and procedural complications
Burn	0/8 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1
Cut	0/8 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1
Lower extremity fracture	1/8 (12.5%)	1	0/9 (0%)	0	1/7 (14.3%)	2
Toe wound	1/8 (12.5%)	1	0/9 (0%)	0	0/7 (0%)	0
Musculoskeletal and connective tissue disorders
Musculoskeletal pain	3/8 (37.5%)	3	1/9 (11.1%)	1	3/7 (42.9%)	6
Nervous system disorders
Headache	0/8 (0%)	0	2/9 (22.2%)	2	0/7 (0%)	0
Pinched nerve	0/8 (0%)	0	1/9 (11.1%)	2	0/7 (0%)	0
Renal and urinary disorders
Hyponatremia	0/8 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1
Nephrolithiasis	0/8 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0
Urinary tract infection	0/8 (0%)	0	1/9 (11.1%)	1	1/7 (14.3%)	1
Skin and subcutaneous tissue disorders
Acne	2/8 (25%)	2	0/9 (0%)	0	0/7 (0%)	0
Dry scalp	1/8 (12.5%)	1	0/9 (0%)	0	0/7 (0%)	0
Pressure sore	0/8 (0%)	0	1/9 (11.1%)	1	2/7 (28.6%)	3
Rash	0/8 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.