Trial record 14 of 1102 for:    "Spinal Cord Diseases"

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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University
ClinicalTrials.gov Identifier:
NCT02025179
First received: December 21, 2013
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injury
Bone Loss
Osteoporosis
Drug: Teriparatide
Device: Vibration
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Bone Mass Density (BMD) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    To determine if a second year of teriparatide treatment will result in an increase in BMD compared to baseline BMD values in people with chronic SCI.


Secondary Outcome Measures:
  • Serum markers of bone metabolism [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    To determine the effects of continued teriparatide on serum markers of bone metabolism


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Forteo
Device: Vibration
Vibration 10 min/day for 12 months
Other Name: Soloflex WBV platorm

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02025179

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Thomas J Schnitzer, MD, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Thomas J. Schnitzer, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02025179     History of Changes
Other Study ID Numbers: A1195
Study First Received: December 21, 2013
Last Updated: December 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
Spinal Cord Diseases
Teriparatide
Osteoporosis
Spinal Cord Injury
Bone Diseases
Metabolic Bone Diseases
Musculoskeletal 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:
Spinal Cord Diseases
Osteoporosis
Spinal Cord Injuries
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014