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

NCT02025179 | Completed Phase 2 Results DMC

• 1 other identifier: A1195
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

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

  The mean percent change in BMD of the total hip after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The "Baseline" refers to the baseline at the parent protocol (NCT01225055). The "24 months" refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179).

  Baseline to 24 months

Secondary Outcomes (5)

• C-terminal Telopeptide

  Baseline to 24 Months

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

  Baseline to 24 Months

• Bone Mineral Density (BMD) by DXA at Femoral Neck

  Baseline to 24 Months

• Amino-terminal Propeptide of Type 1 Collagen

  Baseline to 24 Months

• Bone-specific Alkaline Phosphatase

  Baseline to 24 Months

Study Arms (1)

Teriparatide and vibration

EXPERIMENTAL

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; Device: Vibration

Interventions

Teriparatide DRUG

Teriparatide 20 ug daily Sub-Q over 12 months

Also known as: Forteo

Teriparatide and vibration

Vibration DEVICE

Vibration 10 min/day for 12 months

Also known as: Soloflex Whole Body Vibration platform

Teriparatide and vibration

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Bone Diseases, Metabolic; Osteoporosis; Bone Diseases; Musculoskeletal Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Thomas Schnitzer
• Organization: Northwestern University

tjs@northwestern.edu

312-503-2315

Study Officials

• Thomas J Schnitzer, MD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2013
• First Posted: December 31, 2013
• Study Start: January 1, 2013
• Primary Completion: August 14, 2015
• Study Completion: August 14, 2015
• Last Updated: May 10, 2023
• Results First Posted: September 25, 2018

Record last verified: 2018-08

Locations

US (1)