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Risedronate for the Treatment of Osteoporosis for People With Spinal Cord Injury

Risedronate for Treatment of Sublesional Osteoporosis After Spinal Cord Injury

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00138866
Enrollment
46
Registered
2005-08-30
Start date
2004-11-30
Completion date
2009-03-31
Last updated
2010-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

Spinal cord injury

Brief summary

The purpose of this study is to find out if risedronate works for the treatment of osteoporosis for people with spinal cord injury.

Interventions

DRUGRisedronate

Sponsors

The Physicians' Services Incorporated Foundation
CollaboratorOTHER
St. Joseph's Health Care London
CollaboratorOTHER
Toronto Rehabilitation Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Traumatic spinal cord injury of greater than 18 months * Osteopenia or osteoporosis of the hip * Must be able to swallow tablets and sit upright

Exclusion criteria

* Bilateral heterotopic ossification * Bilateral lower extremity metal implants * Pregnant or lactating females * Paget's disease * Osteomalacia * Steroid induced bone loss * Untreated parathyroid or thyroid disease * Symptomatic hypocalcemia or hypophosphatemia * Treatment in the last year with calcitonin, fluoride or anabolic steroids * Current treatment with prednisone

Design outcomes

Primary

MeasureTime frame
Change in bone mineral density of the distal femur between baseline and 18-months18 months

Secondary

MeasureTime frame
Change in bone mineral density of the hips and proximal tibia between baseline and 18-months18 months
The change in biochemical bone markers of bone turnover between baseline and 18-months18 months
The frequency and severity of adverse events18 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026