NCT00150683

Brief Summary

The purpose of this study is to find out if standing and/or standing with vibration works for the treatment of osteoporosis for people with a spinal cord injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 1999

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

September 8, 2005

Status Verified

September 1, 2005

First QC Date

September 6, 2005

Last Update Submit

September 6, 2005

Conditions

Spinal Cord Injury.Osteoporosis.

Keywords

Spinal Cord Injury.Osteoporosis.Standing.Vibration.

Outcome Measures

Primary Outcomes (1)

  • Change in bone mineral density from baseline of the hip, distal femur and proximal tibia at 6-months and 12-months.

Secondary Outcomes (3)

  • Spasticity (modified Ashworth).

  • Quality of life.

  • Frequency and severity of adverse events.

Interventions

vibration and passive standing versus passive standing aloneDEVICE

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Traumatic spinal cord injury of greater than 12 months.
  • Osteopenia or osteoporosis of the hip.

You may not qualify if:

  • Pregnant or lactating females.
  • Nonunion lower extremity fracture within the last 6 months.
  • Bilateral hip or knee flexion contractures.
  • Bilateral lower extremity total hip or knee replacement.
  • Heterotopic ossification of the hip or knee.
  • Concurrent treatment with a bisphosphonate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Rehab, Lyndhurst Centre

Toronto, Ontario, M4G 3V9, Canada

Location

MeSH Terms

Conditions

Spinal Cord InjuriesOsteoporosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • B. Cathy Craven, BPHE

    Toronto Rehabilitation Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

March 1, 1999

Study Completion

July 1, 2001

Last Updated

September 8, 2005

Record last verified: 2005-09

Locations

CA(1)