NCT00150696

Brief Summary

The purpose of this study is to find out if Risedronate works to prevent osteoporosis after spinal cord injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2000

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

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

February 1, 2000

Completed
5.6 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
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

November 21, 2007

Status Verified

November 1, 2007

First QC Date

September 6, 2005

Last Update Submit

November 20, 2007

Conditions

Acute Spinal Cord Injury.

Keywords

OsteoporosisSpinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • Change in bone mineral density of the distal femur and proximal tibia between baseline, 12-months and 24-months.

Secondary Outcomes (4)

  • Change in bone mineral density of the total body, spine and femoral neck between baseline, 12-months and 24-months.

  • Change in biochemical markers of bone turnover between baseline, 12-months and 24-months.

  • Frequency and severity of adverse events.

  • Quality of life.

Interventions

RisedronateDRUG

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Traumatic spinal cord injury less than 100 days.
  • Must be able to swallow tablets and sit upright.

You may not qualify if:

  • Bilateral knee flexion contractures.
  • Pregnant, lactating or post-menopausal females.
  • Paget's disease, osteomalacia, steroid induced bone loss, untreated thyroid disease, iritis, uveitis, pancreatitis, gastritis, peptic ulcer or cholecystitis.
  • Treatment in the last year with calcitonin, fluoride or anabolic steroid.
  • Concurrent treatment with prednisone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hamilton Health Sciences, Chedoke Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

Toronto Rehab, Lyndhurst Centre

Toronto, Ontario, M4G 3V9, Canada

Location

MeSH Terms

Conditions

OsteoporosisSpinal Cord Injuries

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • B. Cathy Craven, MD, FRCPC

    Toronto Rehabilitation Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

February 1, 2000

Study Completion

November 1, 2005

Last Updated

November 21, 2007

Record last verified: 2007-11

Locations

CA(2)