## Protocol Section
### Identification Module
**NCT ID:** NCT02025179

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

**Official Title:** 12 Month Open-Label Extension Study of the Effect of Teriparatide on Bone in People With Chronic SCI

#### Organization Study ID Info
**ID:** A1195
#### Organization
**Class:** OTHER
**Full Name:** Northwestern University
### Status Module
#### Completion Date
**Date:** 2015-08-14

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-05-10

**Type:** ACTUAL

**Last Update Submit Date:** 2023-05-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-08-14

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2018-09-25

**Type:** ACTUAL

**Results First Submit Date:** 2018-05-10

**Results First Submit QC Date:** 2018-08-28

#### Start Date
**Date:** 2013-01

**Type:** ACTUAL

**Status Verified Date:** 2018-08

#### Study First Post Date
**Date:** 2013-12-31
**Type:** ESTIMATED
**Study First Submit Date:** 2013-12-21
**Study First Submit QC Date:** 2013-12-27
### Sponsor Collaborators Module

#### Collaborators

**Class:** FED

**Name:** United States Department of Defense

#### Lead Sponsor

**Class:** OTHER

**Name:** Northwestern University

#### Responsible Party

**Investigator Affiliation:** Northwestern University

**Investigator Full Name:** Thomas J. Schnitzer

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Spinal Cord Injury

- Bone Loss

- Osteoporosis

**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

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 25

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Experimental: Teriparatide and vibration

Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months

Device: Vibration 10 min/day for 12 months

**Intervention Names:**

- Drug: Teriparatide

- Device: Vibration

**Label:** Teriparatide and vibration

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Teriparatide and vibration

**Description:** Teriparatide 20 ug daily Sub-Q over 12 months

**Name:** Teriparatide

**Other Names:**

- Forteo

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Teriparatide and vibration

**Description:** Vibration 10 min/day for 12 months

**Name:** Vibration

**Other Names:**

- Soloflex Whole Body Vibration platform

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**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).

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

**Time Frame:** Baseline to 24 months

#### Secondary Outcomes

**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).

**Measure:** C-terminal Telopeptide

**Time Frame:** Baseline to 24 Months

**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).

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

**Time Frame:** Baseline to 24 Months

**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).

**Measure:** Bone Mineral Density (BMD) by DXA at Femoral Neck

**Time Frame:** Baseline to 24 Months

**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).

**Measure:** Amino-terminal Propeptide of Type 1 Collagen

**Time Frame:** Baseline to 24 Months

**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).

**Measure:** Bone-specific Alkaline Phosphatase

**Time Frame:** Baseline to 24 Months

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chicago

**Country:** United States

**Facility:** Northwestern University Feinberg School of Medicine

**State:** Illinois

**Zip:** 60611

#### Overall Officials

**Official 1:**

**Affiliation:** Northwestern University

**Name:** Thomas J Schnitzer, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013118

- Term: Spinal Cord Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000020196

- Term: Trauma, Nervous System

- ID: D000001851

- Term: Bone Diseases, Metabolic

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Injury

- ID: M12947

- Name: Osteoporosis

- Relevance: HIGH

- As Found: Osteoporosis

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15916

- Name: Spinal Cord Injuries

- Relevance: HIGH

- As Found: Spinal Cord Injury

- ID: M5130

- Name: Bone Diseases, Metabolic

- Relevance: LOW

- As Found: Unknown

- ID: M15915

- Name: Spinal Cord Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010024

- Term: Osteoporosis

- ID: D000013119

- Term: Spinal Cord Injuries

- ID: D000014947

- Term: Wounds and Injuries

### Intervention Browse Module - Ancestors

- ID: D000077264

- Term: Calcium-Regulating Hormones and Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000050071

- Term: Bone Density Conservation Agents

### Intervention Browse Module - Browse Branches

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21349

- Name: Teriparatide

- Relevance: HIGH

- As Found: Same as

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000019379

- Term: Teriparatide

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**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.

#### Event Groups

**Group ID:** EG000

**Title:** Teriparatide

**Deaths Num At Risk:** 8

**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

**ID:** EG000

**Other Num Affected:** 5

**Other Num at Risk:** 8

**Serious Number At Risk:** 8

**Title:** Teriparatide

**Group ID:** EG001

**Title:** Vibration

**Deaths Num At Risk:** 9

**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),

Vibration alone with placebo-teriparatide

vibration: 10 min/day for 12 months

**ID:** EG001

**Other Num Affected:** 7

**Other Num at Risk:** 9

**Serious Number Affected:** 1

**Serious Number At Risk:** 9

**Title:** Vibration

**Group ID:** EG002

**Title:** Teriparatide and Vibration

**Deaths Num At Risk:** 7

**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 with vibration applied in conjunction

Teriparatide: 20 ug daily over 12 months

vibration: 10 min/day for 12 months

**ID:** EG002

**Other Num Affected:** 5

**Other Num at Risk:** 7

**Serious Number Affected:** 2

**Serious Number At Risk:** 7

**Title:** Teriparatide and Vibration

**Frequency Threshold:** 0

#### Other Events

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Acne

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Allergic Reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** 

**Term:** Allergies

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** 

**Term:** Burn

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** 

**Term:** Cold/Flu

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Cut

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Cut Tip of Left Thumb

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** 

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Dry scalp

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Food poisoning

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Hyponatremia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** 

**Term:** Nephrolithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** 

**Term:** Lower extremity fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** 

**Term:** Musculoskeletal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Pinched nerve

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Pressure sore

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Toe wound

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** 

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Urinary Tract Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 8

**Group ID:** EG001

**Num At Risk:** 9

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 7

**Num Events:** 2

**Term:** Breast Cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

##### Stats

**Group ID:** EG000

**Num At Risk:** 8

**Group ID:** EG001

**Num At Risk:** 9

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 7

**Num Events:** 1

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 8

**Group ID:** EG001

**Num At Risk:** 9

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 7

**Num Events:** 1

**Term:** Paresthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 8

**Group ID:** EG001

**Num At Risk:** 9

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 7

**Num Events:** 1

**Term:** Kidney Stone

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 8

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 9

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 7

**Time Frame:** 12 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 8

**Group ID:** BG001

**Value:** 9

**Group ID:** BG002

**Value:** 8

**Group ID:** BG003

**Value:** 25

**Units:** Participants

### Group

**ID:** BG000

**Title:** Teriparatide

**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

### Group

**ID:** BG001

**Title:** Vibration

**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),

Vibration alone with placebo-teriparatide

vibration: 10 min/day for 12 months

### Group

**ID:** BG002

**Title:** Teriparatide and Vibration

**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 with vibration applied in conjunction

Teriparatide: 20 ug daily over 12 months

vibration: 10 min/day for 12 months

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 21.1

**Upper Limit:** 65.3

**Value:** 42.2

#### Measurement

**Group ID:** BG001

**Lower Limit:** 22.2

**Upper Limit:** 62.7

**Value:** 38.0

#### Measurement

**Group ID:** BG002

**Lower Limit:** 22.8

**Upper Limit:** 64.9

**Value:** 41.7

#### Measurement

**Group ID:** BG003

**Lower Limit:** 21.1

**Upper Limit:** 65.3

**Value:** 40.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 3

#### Measurement

**Group ID:** BG003

**Value:** 7

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 5

#### Measurement

**Group ID:** BG003

**Value:** 18

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 5

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 7

#### Measurement

**Group ID:** BG003

**Value:** 20

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 1

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 1

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 5

#### Measurement

**Group ID:** BG003

**Value:** 13

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 3

#### Measurement

**Group ID:** BG003

**Value:** 10

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 7

#### Measurement

**Group ID:** BG003

**Value:** 19

**Category Title:** ASIA A (Complete Injury)

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 2

**Category Title:** ASIA B (Sensory Incomplete Injury)

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 4

**Category Title:** ASIA C (Motor Incomplete Injury)

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** ASIA D (Motor Incomplete Injury)

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Description:** ASIA impairment scale describes a person's functional impairment as a result of their spinal cord injury.

A = Complete. No motor or sensory function in the lowest sacral spine segment (S4-5).

B = Sensory Incomplete. Sensory function below the neurological level of injury (NLI) and in S4-S5, no motor function below NLI.

C = Motor Incomplete. Motor function is preserved below NLI and more than half of the key muscle groups below NLI have a muscle grade \< 3.

D = Motor Incomplete. Motor function is preserved below NLI and at least half of the key muscle groups below NLI have a muscle grade 3.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** American Spinal Injury Association (ASIA) Impairment Scale
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** tjs@northwestern.edu
**Organization:** Northwestern University
**Phone:** 312-503-2315
**Title:** Dr. Thomas Schnitzer
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.37
- **Spread:** 
- **Upper Limit:** 10.1
- **Value:** 6.73
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -3.50
- **Spread:** 
- **Upper Limit:** 2.82
- **Value:** -0.34
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 0.37
- **Spread:** 
- **Upper Limit:** 8.11
- **Value:** 4.24
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -69.0
- **Spread:** 
- **Upper Limit:** 29.5
- **Value:** -19.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -61.2
- **Spread:** 
- **Upper Limit:** 31.6
- **Value:** -14.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -54.8
- **Spread:** 
- **Upper Limit:** 50.5
- **Value:** -2.12
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 11.0
- **Spread:** 
- **Upper Limit:** 17.8
- **Value:** 14.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.87
- **Spread:** 
- **Upper Limit:** 10.2
- **Value:** 7.05
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 5.08
- **Spread:** 
- **Upper Limit:** 12.9
- **Value:** 8.98
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.81
- **Spread:** 
- **Upper Limit:** 8.26
- **Value:** 2.73
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -5.28
- **Spread:** 
- **Upper Limit:** 5.16
- **Value:** -0.06
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -1.20
- **Spread:** 
- **Upper Limit:** 10.6
- **Value:** 4.71
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 73
- **Spread:** 
- **Upper Limit:** 132
- **Value:** 102
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 76.6
- **Spread:** 
- **Upper Limit:** 132
- **Value:** 104
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 26.6
- **Spread:** 
- **Upper Limit:** 89.5
- **Value:** 58
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 9.04
- **Spread:** 
- **Upper Limit:** 14.0
- **Value:** 11.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 10.3
- **Spread:** 
- **Upper Limit:** 14.9
- **Value:** 12.6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 8.30
- **Spread:** 
- **Upper Limit:** 13.6
- **Value:** 10.9
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**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).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** One subject in "Teriparatide and vibration" group was lost to follow-up
**Reporting Status:** POSTED
**Time Frame:** Baseline to 24 months
**Title:** Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA)
**Type:** PRIMARY
**Unit of Measure:** Percent change
##### 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
**ID:** OG000
**Title:** Teriparatide
##### 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),

Vibration alone with placebo-teriparatide

vibration: 10 min/day for 12 months
**ID:** OG001
**Title:** Vibration
##### 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 with vibration applied in conjunction

Teriparatide: 20 ug daily over 12 months

vibration: 10 min/day for 12 months
**ID:** OG002
**Title:** Teriparatide and Vibration
#### Outcome Measure 2
**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).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** One subject in "Teriparatide and vibration" group was lost to follow-up
**Reporting Status:** POSTED
**Time Frame:** Baseline to 24 Months
**Title:** C-terminal Telopeptide
**Type:** SECONDARY
**Unit of Measure:** Percent change
##### 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
**ID:** OG000
**Title:** Teriparatide
##### 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),

Vibration alone with placebo-teriparatide

vibration: 10 min/day for 12 months
**ID:** OG001
**Title:** Vibration
##### 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 with vibration applied in conjunction

Teriparatide: 20 ug daily over 12 months

vibration: 10 min/day for 12 months
**ID:** OG002
**Title:** Teriparatide and Vibration
#### Outcome Measure 3
**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).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**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.
**Reporting Status:** POSTED
**Time Frame:** Baseline to 24 Months
**Title:** Bone Mineral Density (BMD) by DXA at the Lumbar Spine
**Type:** SECONDARY
**Unit of Measure:** Percent change
##### 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
**ID:** OG000
**Title:** Teriparatide
##### 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),

Vibration alone with placebo-teriparatide

vibration: 10 min/day for 12 months
**ID:** OG001
**Title:** Vibration
##### 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 with vibration applied in conjunction

Teriparatide: 20 ug daily over 12 months

vibration: 10 min/day for 12 months
**ID:** OG002
**Title:** Teriparatide and Vibration
#### Outcome Measure 4
**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).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** One subject in "Teriparatide and vibration" group was lost to follow-up
**Reporting Status:** POSTED
**Time Frame:** Baseline to 24 Months
**Title:** Bone Mineral Density (BMD) by DXA at Femoral Neck
**Type:** SECONDARY
**Unit of Measure:** Percent change
##### 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
**ID:** OG000
**Title:** Teriparatide
##### 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),

Vibration alone with placebo-teriparatide

vibration: 10 min/day for 12 months
**ID:** OG001
**Title:** Vibration
##### 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 with vibration applied in conjunction

Teriparatide: 20 ug daily over 12 months

vibration: 10 min/day for 12 months
**ID:** OG002
**Title:** Teriparatide and Vibration
#### Outcome Measure 5
**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).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** One subject in "Teriparatide and vibration" group was lost to follow-up
**Reporting Status:** POSTED
**Time Frame:** Baseline to 24 Months
**Title:** Amino-terminal Propeptide of Type 1 Collagen
**Type:** SECONDARY
**Unit of Measure:** Percent change
##### 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
**ID:** OG000
**Title:** Teriparatide
##### 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),

Vibration alone with placebo-teriparatide

vibration: 10 min/day for 12 months
**ID:** OG001
**Title:** Vibration
##### 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 with vibration applied in conjunction

Teriparatide: 20 ug daily over 12 months

vibration: 10 min/day for 12 months
**ID:** OG002
**Title:** Teriparatide and Vibration
#### Outcome Measure 6
**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).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** One subject in "Teriparatide and vibration" group was lost to follow-up
**Reporting Status:** POSTED
**Time Frame:** Baseline to 24 Months
**Title:** Bone-specific Alkaline Phosphatase
**Type:** SECONDARY
**Unit of Measure:** Percent change
##### 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
**ID:** OG000
**Title:** Teriparatide
##### 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),

Vibration alone with placebo-teriparatide

vibration: 10 min/day for 12 months
**ID:** OG001
**Title:** Vibration
##### 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 with vibration applied in conjunction

Teriparatide: 20 ug daily over 12 months

vibration: 10 min/day for 12 months
**ID:** OG002
**Title:** Teriparatide and Vibration
### Participant Flow Module
#### 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
**ID:** FG000
**Title:** Teriparatide
#### 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),

Vibration alone with placebo-teriparatide

vibration: 10 min/day for 12 months
**ID:** FG001
**Title:** Vibration
#### 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 with vibration applied in conjunction

Teriparatide: 20 ug daily over 12 months

vibration: 10 min/day for 12 months
**ID:** FG002
**Title:** Teriparatide and Vibration
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 9
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 8
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 9
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 7
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 1
**Has Results:** True