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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2009-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Risedronate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Toronto Rehab Institute

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

B. Cathy Craven, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Toronto Rehabilitation Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Toronto Rehab, Lyndhurst Centre

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PSI #03-52

Identifier Type: -

Identifier Source: secondary_id

TRI REB #04-016