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CompletedNCT00150696Updated Nov 21, 2007

Risedronate for the Prevention of Osteoporosis in People With Spinal Cord Injury.

A Phase 3 interventional study of Risedronate in Acute Spinal Cord Injury., sponsored by Toronto Rehabilitation Institute. Completed at 2 sites in Canada. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2007-11-21.

Sponsored by Toronto Rehabilitation Institute · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
16 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Acute Spinal Cord Injury.

Keywords

  • Osteoporosis
  • Spinal Cord Injury
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 38 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Toronto Rehabilitation Institute is the lead sponsor of 39 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
38 participants

Interventions

  • DrugRisedronate
06

What researchers measure

Primary outcomes

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

Secondary outcomes

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

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

  3. Frequency and severity of adverse events.

  4. Quality of life.

07

Study locations

2 sites
  • Hamilton Health Sciences, Chedoke Site
    Hamilton, Ontario L8N 3Z5, Canada
  • Toronto Rehab, Lyndhurst Centre
    Toronto, Ontario M4G 3V9, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00150696
Lead sponsor
Toronto Rehabilitation Institute
Collaborators
Ontario Neurotrauma Foundation, St. Joseph's Healthcare Foundation, Queen Elizabeth Hospital NHS Foundation Trust
First posted
Sep 8, 2005
Start date
Feb 2000
Completion
Nov 2005
Last update
Nov 21, 2007

Study contacts

B. Cathy Craven, MD, FRCPC
principal investigator · Toronto Rehabilitation Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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