Acute Spinal Cord Injury.Phase 3NCT00150696
Risedronate for the Prevention of Osteoporosis in People With Spinal Cord Injury.
A Phase 3 study testing Risedronate in people with Acute Spinal Cord Injury., run by Toronto Rehabilitation Institute at 2 sites in Canada.
Trial summary
The purpose of this study is to find out if Risedronate works to prevent osteoporosis after spinal cord injury. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Acute Spinal Cord Injury.
- What is being tested?
- Risedronate
- How many people
- 38 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2000to Nov 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Traumatic spinal cord injury less than 100 days.
- Must be able to swallow tablets and sit upright.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hamilton Health Sciences, Chedoke Site
Hamilton, Ontario, L8N 3Z5
Toronto Rehab, Lyndhurst Centre
Toronto, Ontario, M4G 3V9
About this study
Official title: Risedronate for Prevention of Osteoporosis After Spinal Cord Injury
The purpose of this study is to find out if Risedronate works to prevent osteoporosis after spinal cord injury.
- Conditions
- Acute Spinal Cord Injury.
- Being tested
- Risedronate
- Keywords
- Osteoporosis, Spinal Cord Injury
- Medical subject headings
- Osteoporosis, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisedronateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startFeb 2000
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord Injury.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 38 participants
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation, St. Joseph's Healthcare Foundation, Queen Elizabeth Hospital NHS Foundation Trust
- Investigators
- B. Cathy Craven, MD, FRCPC, Principal investigator, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150696
- Sponsor's protocol ID
- TRI REB #02-040
- Other IDs
- ONRO-79
- Status last verified
- Nov 2007
- First submitted
- 6 Sep 2005
- Last updated
- 21 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risedronate for Prevention of Osteoporosis After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00150696
- Acronym / sponsor ID
- TRI REB #02-040
- Conditions
- Acute Spinal Cord Injury.
- Keywords
- Osteoporosis, Spinal Cord Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation, St. Joseph's Healthcare Foundation, Queen Elizabeth Hospital NHS Foundation Trust
- Study start
- Feb 2000
- Study completion
- Nov 2005
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if Risedronate works to prevent osteoporosis after spinal cord injury.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Traumatic spinal cord injury less than 100 days.
- Must be able to swallow tablets and sit upright.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risedronate | Drug | – |
Primary outcome
Change in bone mineral density of the distal femur and proximal tibia between baseline, 12-months and 24-months.
4 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2007.
Related trials for Acute Spinal Cord Injury.
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Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
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Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
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Functional Electrical Stimulation vs Transcutaneous Stimulation in Patients With Subacute Spinal Cord Injury
Non Traumatic Spinal Cord Injury, Sub-Acute Rehabilitation
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NG004 in Incomplete Spinal Cord Injury Patients
Acute Spinal Cord Injury (SCI), Spinal Cord Diseases
Recruiting
Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial
Spinal Cord Injuries, Spinal Cord Injury (SCI), Initial Encounter
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
B. Cathy Craven, MD, FRCPC principal investigator
Toronto Rehabilitation Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Risedronate in people with Acute Spinal Cord Injury., run by Toronto Rehabilitation Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone mineral density of the distal femur and proximal tibia between baseline, 12-months and 24-months.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2007.