Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury

• Sponsor: Thomas J. Schnitzer (Other)
• Overall Status: Completed
• CT.gov ID: NCT01225055
• Collaborator: Edward Hines Jr. VA Hospital (U.S. Fed), University of Illinois at Chicago (Other)
• Enrollment: 60
• Locations: 2
• Arms: 3
• Duration (Months): 70
• Patients Per Site: 30
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Spinal cord injury (SCI) results in marked acute loss of bone. This study evaluates the effect of teriparatide (PTH) and the use of vibration as a form of mechanical stimulation on bone mass.

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

Detailed Description

The aim of this study is to evaluate PTH with vibration in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 60 subjects with SCI will be enrolled into a 12 month study assessing the effects of PTH (20 ug/day) and vibration (10 min/day) individually or in combination on BMD and bone markers. Subjects will be evaluated at 3, 6, 9, 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: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Teriparatide Teriparatide alone with sham vibration	Drug: Teriparatide; 20 ug daily over 12 months; Other Names: Forteo
Experimental: Vibration Vibration alone with placebo-teriparatide	Device: vibration; 10 min/day for 12 months
Experimental: Teriparatide and vibration Teriparatide with vibration applied in conjuction	Drug: Teriparatide; 20 ug daily over 12 months; Other Names: Forteo ; Device: vibration; 10 min/day for 12 months

Outcome Measures

Primary Outcome Measures

1. Bone Mineral Density BMD of the Total Hip as Assessed by DXA. [Baseline to 12 Months]

   The mean change in BMD of the total hip after 12 month of treatment

Secondary Outcome Measures

1. Bone Mineral Density (BMD) by DXA at the Lumbar Spine. [Baseline to 12 Months]

   The mean change in BMD at the lumbar spine from baseline after 12 month of treatment

2. Bone Mineral Density (BMD) by DXA at Femoral Neck [Baseline to 12 Months]

   The mean change in BMD of the femoral neck after 12 month of treatment

3. C-terminal Telopeptide [Baseline to 12 Months]

   The mean change in C-terminal telopeptide from baseline after 12 month of treatment

4. Bone-specific Alkaline Phosphatase [Baseline to 12 Months]

   The mean change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy

5. Amino-terminal Propeptide of Type 1 Collagen [Baseline to 12 Months]

   The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment

Eligibility Criteria

Criteria

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

Inclusion Criteria:

Age >21 years (must have closed epiphyses; PTH contraindicated if epiphyses open)

• Both males and females

• SCI with inability to ambulate independently

• Capable of positioning to have DXA performed

• Low bone mass at the total hip by DEXA (Z score < 1.5; T score < 2.5 or T score <-2.0 plus preexisting fragility fracture)

• Capable of reading and understanding informed consent document

• Able to self-administer teriparatide or have someone in the family who can do so

• No known endocrinopathies

• Normal TSH levels

• Normal 25-OH vitamin D levels (> 30ng/ml)

• Normal calcium levels

• Normal renal function (creatinine <2.0mg/dl)

• Able to return for all follow-up visits

Exclusion Criteria:

Surgical or other intervention resulting in metal or anatomy precluding obtaining DXA measurements (e.g., cardiac pacemakers, ferromagnetic implants or brain aneurysm clips).

• Had had an allergic reaction to Teriparatide (FORTEO) or one of its ingredients.

• Have Paget's disease of the bone

• Have unexplained high levels of f alkaline phosphatase in blood

• Any active Gastrointestinal condition that results in malabsorption

• History of presence of alcoholism or drug abuse within the 2 years prior to study screening

• Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study

• History of malignancy. Patients having had basal cell carcinomas successfully removed will be allowed to enroll in the protocol.

• History of radiation therapy

• Unable to self-administer PTH or have it administered

• Elevated liver function tests >2x normal

• Currently being prescribed anti-convulsants

• Currently being prescribed glucocorticoids, other than inhaled glucocorticoids

• Currently being prescribed any bone-active agents, including any bisphosphonate, raloxifene, hormone therapy (estrogen and estrogen/progestin), calcitonin or strontium-containing compounds. Bisphosphonate use will be allowed up the time of initiation of study medication but not during the dosing with study medication.

• Previous history of PTH use

• Pregnant, planning to become pregnant, or lactating

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611
2	Edward Hines, Jr, VA Hospital	Maywood	Illinois	United States	60153

Sponsors and Collaborators

• Thomas J. Schnitzer
• Edward Hines Jr. VA Hospital
• University of Illinois at Chicago

Investigators

• Principal Investigator: Thomas J Schnizter, 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: NCT01225055
• Other Study ID Numbers: STU00033380
• First Posted: Oct 20, 2010
• Last Update Posted: Jun 29, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Osteoporosis; Spinal Cord Injuries; Wounds and Injuries; Teriparatide

Study Results

Participant Flow

Pre-assignment Detail	One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. After consenting the subject did not participate in the study.. This accounts for the 61 in Participant Flow but 60 that were enrolled and started treatment according to their assigned group.

Arm/Group Title	Teriparatide	Vibration	Teriparatide and Vibration
Arm/Group Description	Teriparatide alone with sham vibration Teriparatide: 20 ug daily over 12 months	Vibration alone with placebo-teriparatide vibration: 10 min/day for 12 months	Teriparatide with vibration applied in conjuction Teriparatide: 20 ug daily over 12 months vibration: 10 min/day for 12 months
Period Title: Overall Study
STARTED	20	20	21
COMPLETED	20	18	18
NOT COMPLETED	0	2	3

Baseline Characteristics

Arm/Group Title	Teriparatide	Vibration	Teriparatide and Vibration	Total
Arm/Group Description	Teriparatide alone with sham vibration Teriparatide: 20 ug daily over 12 months	Vibration alone with placebo-teriparatide vibration: 10 min/day for 12 months	Teriparatide with vibration applied in conjuction Teriparatide: 20 ug daily over 12 months vibration: 10 min/day for 12 months	Total of all reporting groups
Overall Participants	20	20	21	61
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	16 80%	18 90%	19 90.5%	53 86.9%
>=65 years	4 20%	2 10%	2 9.5%	8 13.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.6 (16.3)	40.9 (16.4)	46.6 (15.4)	45.4 (16.3)
Sex: Female, Male (Count of Participants)
Female	3 15%	6 30%	5 23.8%	14 23%
Male	17 85%	14 70%	16 76.2%	47 77%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 30%	4 20%	6 28.6%	16 26.2%
Not Hispanic or Latino	14 70%	16 80%	15 71.4%	45 73.8%
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 5%	0 0%	1 1.6%
Native Hawaiian or Other Pacific Islander	0 0%	2 10%	0 0%	2 3.3%
Black or African American	9 45%	10 50%	14 66.7%	33 54.1%
White	11 55%	7 35%	7 33.3%	25 41%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	21 100%	60 98.4%

Outcome Measures

1. Primary Outcome

Title	Bone Mineral Density BMD of the Total Hip as Assessed by DXA.
Description	The mean change in BMD of the total hip after 12 month of treatment
Time Frame	Baseline to 12 Months

Outcome Measure Data

Analysis Population Description

One subject withdrew prior to receiving therapy. The samples from the Hines location (n=11) were also not included. Two additional subjects were not analyzed due to metal artifacts or heterotopic ossification that interfered with analysis. This accounts for the 14 subjects that were not analyzed.

Arm/Group Title	Teriparatide	Vibration	Teriparatide and Vibration
Arm/Group Description	Teriparatide alone with sham vibration Teriparatide: 20 ug daily over 12 months	Vibration alone with placebo-teriparatide vibration: 10 min/day for 12 months	Teriparatide with vibration applied in conjuction Teriparatide: 20 ug daily over 12 months vibration: 10 min/day for 12 months
Measure Participants	15	17	15
0 months	0.66 (0.03)	0.63 (0.03)	0.64 (0.03)
3 months	0.65 (0.03)	0.63 (0.03)	0.65 (0.03)
6 months	0.67 (0.03)	0.63 (0.03)	0.65 (0.03)
12 months	0.66 (0.03)	0.64 (0.03)	0.65 (0.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Teriparatide, Vibration, Teriparatide and Vibration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.84
	Comments	calculated p-value indicating the effect of different treatment groups
	Method	ANOVA
	Comments	Repeated measures ANOVA

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Teriparatide, Vibration, Teriparatide and Vibration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments	calculated p-value indicating the effect of different time points
	Method	ANOVA
	Comments	Repeated measures ANOVA

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Teriparatide, Vibration, Teriparatide and Vibration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.26
	Comments	calculated p-value indicating the effect of different treatment groups and time points
	Method	ANOVA
	Comments	Repeated measures ANOVA

2. Secondary Outcome

Title	Bone Mineral Density (BMD) by DXA at the Lumbar Spine.
Description	The mean change in BMD at the lumbar spine from baseline after 12 month of treatment
Time Frame	Baseline to 12 Months

Outcome Measure Data

Analysis Population Description

One subject withdrew prior to receiving therapy. The samples from the Hines location (n=11) were also not included. Five additional subjects were not analyzed due to metal artifacts that interfered with analysis. This accounts for the 17 subjects that were not analyzed.

Arm/Group Title	Teriparatide	Vibration	Teriparatide and Vibration
Arm/Group Description	Teriparatide alone with sham vibration Teriparatide: 20 ug daily over 12 months	Vibration alone with placebo-teriparatide vibration: 10 min/day for 12 months	Teriparatide with vibration applied in conjuction Teriparatide: 20 ug daily over 12 months vibration: 10 min/day for 12 months
Measure Participants	16	14	14
0 months	1.04 (0.04)	1.00 (0.04)	1.02 (0.04)
3 months	1.05 (0.04)	1.01 (0.04)	1.04 (0.04)
6 months	1.07 (0.04)	1.02 (0.04)	1.05 (0.04)
12 months	1.09 (0.04)	1.02 (0.04)	1.07 (0.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Teriparatide, Vibration, Teriparatide and Vibration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments	calculated p-value indicating the effect of different treatment groups
	Method	ANOVA
	Comments	Repeated measures ANOVA

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Teriparatide, Vibration, Teriparatide and Vibration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.00
	Comments	calculated p-value indicating the effect of different time points
	Method	ANOVA
	Comments	Repeated measures ANOVA

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Teriparatide, Vibration, Teriparatide and Vibration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.09
	Comments	calculated p-value indicating the effect of different treatment groups and time points
	Method	ANOVA
	Comments	Repeated measures ANOVA

3. Secondary Outcome

Title	Bone Mineral Density (BMD) by DXA at Femoral Neck
Description	The mean change in BMD of the femoral neck after 12 month of treatment
Time Frame	Baseline to 12 Months

Outcome Measure Data

Analysis Population Description

One subject withdrew prior to receiving therapy. The samples from the Hines location (n=11) were also not included. One additional subjects was not analyzed due to metal artifacts or heterotopic ossification that interfered with analysis. This accounts for the 13 subjects that were not analyzed.

Arm/Group Title	Teriparatide	Vibration	Teriparatide and Vibration
Arm/Group Description	Teriparatide alone with sham vibration Teriparatide: 20 ug daily over 12 months	Vibration alone with placebo-teriparatide vibration: 10 min/day for 12 months	Teriparatide with vibration applied in conjuction Teriparatide: 20 ug daily over 12 months vibration: 10 min/day for 12 months
Measure Participants	15	17	16
0 months	0.66 (0.03)	0.63 (0.03)	0.62 (0.03)
3 months	0.66 (0.04)	0.64 (0.04)	0.63 (0.04)
6 months	0.67 (0.04)	0.62 (0.03)	0.63 (0.04)
12 months	0.66 (0.03)	0.63 (0.03)	0.63 (0.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Teriparatide, Vibration, Teriparatide and Vibration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.72
	Comments	calculated p-value indicating the effect of different treatment groups
	Method	ANOVA
	Comments	Repeated measures ANOVA

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Teriparatide, Vibration, Teriparatide and Vibration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.58
	Comments	calculated p-value indicating the effect of different time points
	Method	ANOVA
	Comments	Repeated measures ANOVA

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Teriparatide, Vibration, Teriparatide and Vibration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments	calculated p-value indicating the effect of different treatment groups and time points
	Method	ANOVA
	Comments	Repeated measures ANOVA

4. Secondary Outcome

Title	C-terminal Telopeptide
Description	The mean change in C-terminal telopeptide from baseline after 12 month of treatment
Time Frame	Baseline to 12 Months

Outcome Measure Data

Analysis Population Description

One subject withdrew prior to receiving therapy from the Teriparatide and Vibration group. One sample was lost due to laboratory error. The samples from the Hines location (n=11) were also not included in this analysis. This accounts for the 13 subjects that were not analyzed.

Arm/Group Title	Teriparatide	Vibration	Teriparatide and Vibration
Arm/Group Description	Teriparatide alone with sham vibration Teriparatide: 20 ug daily over 12 months	Vibration alone with placebo-teriparatide vibration: 10 min/day for 12 months	Teriparatide with vibration applied in conjuction Teriparatide: 20 ug daily over 12 months vibration: 10 min/day for 12 months
Measure Participants	15	17	16
0 months	0.38 (0.07)	0.31 (0.06)	0.38 (0.06)
3 months	0.72 (0.11)	0.25 (0.10)	0.43 (0.11)
6 months	0.74 (0.11)	0.25 (0.11)	0.44 (0.11)
12 months	0.59 (0.11)	0.29 (0.11)	0.45 (0.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Teriparatide, Vibration, Teriparatide and Vibration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments	calculated p-value indicating the effect of different treatment groups
	Method	ANOVA
	Comments	Repeated measures ANOVA

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Teriparatide, Vibration, Teriparatide and Vibration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.10
	Comments	calculated p-value indicating the effect of different time points
	Method	ANOVA
	Comments	Repeated measures ANOVA

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Teriparatide, Vibration, Teriparatide and Vibration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments	calculated p-value indicating the effect of different treatment groups and time points
	Method	ANOVA
	Comments	Repeated measures ANOVA

5. Secondary Outcome

Title	Bone-specific Alkaline Phosphatase
Description	The mean change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy
Time Frame	Baseline to 12 Months

Outcome Measure Data

Analysis Population Description

One subject withdrew prior to receiving therapy from the Teriparatide and Vibration group. One sample was lost due to laboratory error. The samples from the Hines location (n=11) were also not included in this analysis. This accounts for the 13 subjects that were not analyzed.

Arm/Group Title	Teriparatide	Vibration	Teriparatide and Vibration
Arm/Group Description	Teriparatide alone with sham vibration Teriparatide: 20 ug daily over 12 months	Vibration alone with placebo-teriparatide vibration: 10 min/day for 12 months	Teriparatide with vibration applied in conjuction Teriparatide: 20 ug daily over 12 months vibration: 10 min/day for 12 months
Measure Participants	15	17	16
0 months	15.3 (1.63)	13.9 (1.53)	12.4 (1.58)
3 months	18.4 (1.81)	11.6 (1.70)	12.8 (1.75)
6 months	20.3 (2.64)	11.3 (2.48)	16.2 (2.56)
12 months	20.4 (1.58)	11.8 (1.48)	14.0 (1.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Teriparatide, Vibration, Teriparatide and Vibration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments	calculated p-value indicating the effect of different treatment groups
	Method	ANOVA
	Comments	Repeated measures ANOVA

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Teriparatide, Vibration, Teriparatide and Vibration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.34
	Comments	calculated p-value indicating the effect of different time points
	Method	ANOVA
	Comments	Repeated measures ANOVA

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Teriparatide, Vibration, Teriparatide and Vibration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.20
	Comments	calculated p-value indicating the effect of different treatment groups and time points
	Method	ANOVA
	Comments	Repeated measures ANOVA

6. Secondary Outcome

Title	Amino-terminal Propeptide of Type 1 Collagen
Description	The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment
Time Frame	Baseline to 12 Months

Outcome Measure Data

Analysis Population Description

One subject withdrew prior to receiving therapy from the Teriparatide and Vibration group. One sample was lost due to laboratory error. The samples from the Hines location (n=11) were also not included in this analysis. This accounts for the 13 subjects that were not analyzed.

Arm/Group Title	Teriparatide	Vibration	Teriparatide and Vibration
Arm/Group Description	Teriparatide alone with sham vibration Teriparatide: 20 ug daily over 12 months	Vibration alone with placebo-teriparatide vibration: 10 min/day for 12 months	Teriparatide with vibration applied in conjuction Teriparatide: 20 ug daily over 12 months vibration: 10 min/day for 12 months
Measure Participants	15	17	16
0 months	67.1 (8.90)	64.7 (8.36)	67.9 (8.61)
3 months	128 (12.9)	51.8 (12.1)	90.1 (12.5)
6 months	163 (30.4)	54.5 (28.6)	125 (29.4)
12 months	124 (13.5)	49.8 (12.7)	77.0 (13.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Teriparatide, Vibration, Teriparatide and Vibration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.00
	Comments	calculated p-value indicating the effect of different treatment groups
	Method	ANOVA
	Comments	Repeated measures ANOVA

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Teriparatide, Vibration, Teriparatide and Vibration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments	calculated p-value indicating the effect of different time points
	Method	ANOVA
	Comments	Repeated measures ANOVA

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Teriparatide, Vibration, Teriparatide and Vibration
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments	calculated p-value indicating the effect of different treatment groups and time points
	Method	ANOVA
	Comments	Repeated measures ANOVA

Adverse Events

Time Frame	Baseline to 12 months
Adverse Event Reporting Description	One subject withdrew prior to receiving therapy from the "Teriparatide and Vibration" group. The adverse events for this individual were not reported. This explains why for the "Teriparatide and Vibration" n = 20 rather than n = 21.
Arm/Group Title	Teriparatide		Vibration		Teriparatide and Vibration
Arm/Group Description	Teriparatide alone with sham vibration Teriparatide: 20 ug daily over 12 months		Vibration alone with placebo-teriparatide vibration: 10 min/day for 12 months		Teriparatide with vibration applied in conjuction 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	0/20 (0%)		0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Teriparatide		Vibration		Teriparatide and Vibration
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/20 (35%)		1/20 (5%)		8/20 (40%)
Cardiac disorders
Cardiovascular Event	1/20 (5%)	3	0/20 (0%)	0	0/20 (0%)	0
Injury, poisoning and procedural complications
Injury	0/20 (0%)	0	0/20 (0%)	0	2/20 (10%)	2
Musculoskeletal and connective tissue disorders
Lower extremity fracture	2/20 (10%)	2	0/20 (0%)	0	0/20 (0%)	0
Renal and urinary disorders
Urinary tract infection	4/20 (20%)	5	1/20 (5%)	1	2/20 (10%)	8
Respiratory, thoracic and mediastinal disorders
Pneumonia and respiratory distress	0/20 (0%)	0	0/20 (0%)	0	2/20 (10%)	4
Skin and subcutaneous tissue disorders
Soft tissue infection	0/20 (0%)	0	0/20 (0%)	0	2/20 (10%)	2
Other (Not Including Serious) Adverse Events
	Teriparatide		Vibration		Teriparatide and Vibration
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/20 (80%)		16/20 (80%)		16/20 (80%)
Cardiac disorders
Chest Pain	0/20 (0%)	0	1/20 (5%)	1	1/20 (5%)	2
Gastrointestinal disorders
Acid Reflux	4/20 (20%)	4	0/20 (0%)	0	0/20 (0%)	0
Constipation	4/20 (20%)	4	5/20 (25%)	5	2/20 (10%)	2
Diarrhea	2/20 (10%)	2	1/20 (5%)	1	1/20 (5%)	1
Indigestion	0/20 (0%)	0	0/20 (0%)	0	2/20 (10%)	2
Nausea/Vomitting	4/20 (20%)	4	3/20 (15%)	3	4/20 (20%)	5
Parageusia	0/20 (0%)	0	0/20 (0%)	0	2/20 (10%)	2
Infections and infestations
Flu like symptoms	5/20 (25%)	6	2/20 (10%)	2	2/20 (10%)	4
Injury, poisoning and procedural complications
Injury	2/20 (10%)	2	3/20 (15%)	5	4/20 (20%)	4
Musculoskeletal and connective tissue disorders
Arthralgia	5/20 (25%)	6	1/20 (5%)	1	4/20 (20%)	6
Lower extremity fractures	1/20 (5%)	1	2/20 (10%)	2	1/20 (5%)	1
Lower extremity pain	4/20 (20%)	5	0/20 (0%)	0	1/20 (5%)	2
Nervous system disorders
Dizziness	2/20 (10%)	2	3/20 (15%)	3	7/20 (35%)	8
Headache	2/20 (10%)	2	3/20 (15%)	4	4/20 (20%)	4
Increased Nerve Pain	2/20 (10%)	2	0/20 (0%)	0	2/20 (10%)	3
Increased spasticity	0/20 (0%)	0	0/20 (0%)	0	2/20 (10%)	2
Parathesias	2/20 (10%)	2	0/20 (0%)	0	2/20 (10%)	2
Renal and urinary disorders
Urinary tract infection	9/20 (45%)	11	3/20 (15%)	4	4/20 (20%)	4
Respiratory, thoracic and mediastinal disorders
Rhinorrhea	0/20 (0%)	0	0/20 (0%)	0	2/20 (10%)	2
Upper respiratory infection	6/20 (30%)	6	5/20 (25%)	6	5/20 (25%)	6
Skin and subcutaneous tissue disorders
Bleeding, bruising or irritation at injection site	3/20 (15%)	3	3/20 (15%)	3	6/20 (30%)	6
Burns	1/20 (5%)	1	0/20 (0%)	0	2/20 (10%)	2
Dermatitis	0/20 (0%)	0	5/20 (25%)	5	1/20 (5%)	1
Pressure sore	2/20 (10%)	2	0/20 (0%)	0	3/20 (15%)	7

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.