OsteoporosisPhase 3NCT00138866
Risedronate for the Treatment of Osteoporosis for People With Spinal Cord Injury
A Phase 3 study testing Risedronate in people with Osteoporosis, run by Toronto Rehabilitation Institute at 1 site in Canada.
Trial summary
The purpose of this study is to find out if risedronate works for the treatment of osteoporosis for people with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Risedronate
- How many people
- 46 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2004to Mar 2009
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic spinal cord injury of greater than 18 months
- Osteopenia or osteoporosis of the hip
- Must be able to swallow tablets and sit upright
Who cannot join
- Bilateral heterotopic ossification
- Bilateral lower extremity metal implants
- Pregnant or lactating females
- Paget's disease
- Osteomalacia
- Steroid induced bone loss
Show all 10Show fewer
- Untreated parathyroid or thyroid disease
- Symptomatic hypocalcemia or hypophosphatemia
- Treatment in the last year with calcitonin, fluoride or anabolic steroids
- Current treatment with prednisone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risedronate for Treatment of Sublesional Osteoporosis After Spinal Cord Injury
The purpose of this study is to find out if risedronate works for the treatment of osteoporosis for people with spinal cord injury.
- Conditions
- Osteoporosis
- Being tested
- Risedronate
- Keywords
- 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 between baseline and 18-months
Measured: 18 months
Secondary outcomes (3)
Change in bone mineral density of the hips and proximal tibia between baseline and 18-months
Measured: 18 months
The change in biochemical bone markers of bone turnover between baseline and 18-months
Measured: 18 months
The frequency and severity of adverse events
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startNov 2004
- Primary completionJan 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, St. Joseph's Health Care London
- Investigators
- B. Cathy Craven, MD, FRCPC, Principal investigator, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138866
- Sponsor's protocol ID
- TRI REB #04-016
- Other IDs
- PSI #03-52
- Status last verified
- Jul 2008
- First submitted
- 29 Aug 2005
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risedronate for Treatment of Sublesional Osteoporosis After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00138866
- Acronym / sponsor ID
- TRI REB #04-016
- Conditions
- Osteoporosis
- Keywords
- Spinal cord injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, St. Joseph's Health Care London
- Study start
- Nov 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 30 Aug 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 for the treatment of osteoporosis for people with spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Traumatic spinal cord injury of greater than 18 months
- Osteopenia or osteoporosis of the hip
- Must be able to swallow tablets and sit upright
Key exclusion criteria (10 listed)
- Bilateral heterotopic ossification
- Bilateral lower extremity metal implants
- Pregnant or lactating females
- Paget's disease
- Osteomalacia
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 between baseline and 18-months
Time frame: 18 months
3 secondary outcomes
Change in bone mineral density of the hips and proximal tibia between baseline and 18-months
Time frame: 18 months
The change in biochemical bone markers of bone turnover between baseline and 18-months
Time frame: 18 months
The frequency and severity of adverse events
Time frame: 18 months
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 13 Oct 2010.
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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
1 site 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 Osteoporosis, run by Toronto Rehabilitation Institute at 1 site 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 3 inclusion and 10 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 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 between baseline and 18-months (time frame: 18 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 13 Oct 2010.