Spinal Cord InjuryNCT01131884
Pilot Study of Fosamax in Spinal Cord Injury
A study testing Fosamax in people with Spinal Cord Injury and Osteoporosis, run by University of Rochester at 2 sites in United States.
Trial summary
Study is designed to evaluate the efficacy of oral fosamax in prevention on osteoporosis in acute spinal cord injury. Efficacy will be measured by a duel energy X-Ray absorptiometry (DEXA) scan every 6 months. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Spinal Cord Injury, Osteoporosis
- What is being tested?
- Fosamax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Spinal Cord Injury Association (ASIA) A or American Spinal Cord Injury Association (ASIA) B Spinal Cord Injury
Who cannot join
- History of hypersensitivity to alendronate or other bisphosphonates
- esophageal abnormality
- inability to sit/stand upright for 30 minutes
- creatinine clearance less than 35 milliliters/minute
- hypothyroidism
- malignancy
- pregnancy
- prolonged steroid use
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Rochester Physical Medicine and Rehabilitation
Rochester, New York, 14642
University of Rochester
Rochester, New York, 14642
About this study
Official title: Double Blind Placebo Controlled Trial to Evaluate Preservation of Bone Mineral Density of the Hip and Distal Femur by Biphosphate Therapy (Fosamax) Following Spinal Cord Injury
Study is designed to evaluate the efficacy of oral fosamax in prevention on osteoporosis in acute spinal cord injury. Efficacy will be measured by a duel energy X-Ray absorptiometry (DEXA) scan every 6 months. Patients will complete 3 visits, screening, 6 months, 12 months and be required to take oral fosamax versus placebo weekly.
Read the detailed description
The project was funded on August 13, 2009 and was awarded to one of our trainees, Dr. Matthew Abraham, a PGY3 in our program and our IRB approval was obtained with much time and effort on February 24, 2010. We followed the protocol and so far we recruited just one patient on September 19, 2011 who completed the study but we encountered with many unexpected obstacles to recruit any more patients to the study. The main obstacle was that the spine surgeons' refusal to start the study drug for months after surgery for fear of complications with wound healing. Secondly, the few appropriate and eligible patients we tried to recruit declined to participate.
We were unable to recruit any more patients to this study and hence the study was closed.
The one patient that was recruited completed the study. Since it is only one subject in the study, no conclusions can be drawn.
- Conditions
- Spinal Cord Injury, Osteoporosis
- Being tested
- Fosamax, Placebo
- Keywords
- ASIA A or ASIA B Spinal Cord Injury
- Medical subject headings
- Spinal Cord Injuries, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FosamaxDrug
Also called Alendronate sodiuum
70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
PlaceboDrug
Also called Sugar pill
Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo.
| Study group | Role | What they receive |
|---|---|---|
| Fosamax | Active comparator | Fosamax at 70 mgs q weekly by mouth for the duration of the study. Receives: Drug: Fosamax |
| Placebo Sugar Pill | Placebo comparator | Double blind study using Fosamax versus placebo. Placebo is an inactive drug. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis
Measured: 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Only 1 participant enrolled since the beginning of this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, K. R Poduri, University of Rochester
- Investigators
- Kanakadurga R Poduri, M.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131884
- Sponsor's protocol ID
- U of R 29563
- Status last verified
- Dec 2015
- First submitted
- 25 May 2010
- Last updated
- 29 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Placebo Controlled Trial to Evaluate Preservation of Bone Mineral Density of the Hip and Distal Femur by Biphosphate Therapy (Fosamax) Following Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01131884
- Acronym / sponsor ID
- U of R 29563
- Conditions
- Spinal Cord Injury, Osteoporosis
- Keywords
- ASIA A or ASIA B Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only 1 participant enrolled since the beginning of this study
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 May 2010 (estimated)
- Results
- Posted 16 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study is designed to evaluate the efficacy of oral fosamax in prevention on osteoporosis in acute spinal cord injury. Efficacy will be measured by a duel energy X-Ray absorptiometry (DEXA) scan every 6 months. Patients will complete 3 visits, screening, 6 months, 12 months and be required to take oral fosamax versus placebo weekly.
Detailed description
The project was funded on August 13, 2009 and was awarded to one of our trainees, Dr. Matthew Abraham, a PGY3 in our program and our IRB approval was obtained with much time and effort on February 24, 2010. We followed the protocol and so far we recruited just one patient on September 19, 2011 who completed the study but we encountered with many unexpected obstacles to recruit any more patients to the study. The main obstacle was that the spine surgeons' refusal to start the study drug for months after surgery for fear of complications with wound healing. Secondly, the few appropriate and eligible patients we tried to recruit declined to participate.
We were unable to recruit any more patients to this study and hence the study was closed.
The one patient that was recruited completed the study. Since it is only one subject in the study, no conclusions can be drawn.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fosamax | Active comparator | Drug: FosamaxFosamax at 70 mgs q weekly by mouth for the duration of the study. |
| Placebo Sugar Pill | Placebo comparator | Drug: PlaceboDouble blind study using Fosamax versus placebo. Placebo is an inactive drug. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Spinal Cord Injury Association (ASIA) A or American Spinal Cord Injury Association (ASIA) B Spinal Cord Injury
Key exclusion criteria (8 listed)
- History of hypersensitivity to alendronate or other bisphosphonates
- esophageal abnormality
- inability to sit/stand upright for 30 minutes
- creatinine clearance less than 35 milliliters/minute
- hypothyroidism
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 |
|---|---|---|
| FosamaxAlso: Alendronate sodiuum70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year | Drug | Fosamax |
| PlaceboAlso: Sugar pillPlacebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo. | Drug | Placebo Sugar Pill |
Primary outcome
Bone Mineral Density
Time frame: 1 year after enrollment
Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kanakadurga R Poduri, M.D. principal investigator
University of Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fosamax in people with Spinal Cord Injury and Osteoporosis, run by University of Rochester at 2 sites in United States.
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 1 inclusion and 8 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: stopped early, as of the sponsor's last update on 29 Jan 2016. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bone Mineral Density (time frame: 1 year after enrollment). 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 29 Jan 2016.