OsteoporosisPhase 2/3NCT01426555
FES-Rowing Versus Zoledronic Acid to Improve Bone Health in Spinal Cord Injury (SCI)
A Phase 2/3 study testing FES-Rowing and Zoledronic acid in people with Osteoporosis, run by Antonio Lazzari at 2 sites in United States.
Trial summary
This is a research study to determine the effects of functional electrical stimulation (FES) rowing and a drug called zoledronic acid in bone health. The investigators hoped to learn if zoledronic acid treatment will increase bone mineral density in persons with chronic spinal cord injury (SCI) who received it. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- FES-Rowing and Zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to Feb 2015
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female SCI outpatients
- women of child bearing age will be required to use an acceptable birth control method throughout the study
- aged 18 - over the age of 40
- physician's cardiac clearance to exercise
- who were at least age 14 at time of injury
- who are at least 18 months post injury
- who have a C4 spinal cord injury or lower
Who cannot join
- initial blood pressure higher than 140/90
- patients with orthostatic hypotension
- an active grade 2 or greater pressure ulcers
- lower extremity contractures
- history of significant arrhythmias
- coronary disease
Show all 26Show fewer
- diabetes
- neurological or renal disease
- cancer
- other neurological disease (i.e. stroke, peripheral neuropathy, myopathy)
- any implanted electronic device
- active treatment for epilepsy
- recent weight change
- regular use of tobacco
- family history of arrhythmia or sudden cardiac death
- current use of cardioactive or antidepressant medications
- current use of medications that may affect fracture risk including:
- bisphosphonates
- PTH and PTH analogs
- androgenic steroids
- estrogenic steroids
- glucocorticoids
- antiepileptics
- lithium.
- Any subject with a planned invasive dental procedure will be excluded.
- These criteria will be reviewed by telephone survey followed by a health exam where blood pressure will be assessed and a skin and neurological exam performed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston VAMC
Boston, Massachusetts, 02130
Spaulding Rehab. Hospital
Charlestown, Massachusetts, 02129
About this study
Official title: FES-Rowing Versus Zoledronic Acid to Improve Bone Health in SCI: A Comparative Clinical Trial
This is a research study to determine the effects of functional electrical stimulation (FES) rowing and a drug called zoledronic acid in bone health. The investigators hoped to learn if zoledronic acid treatment will increase bone mineral density in persons with chronic spinal cord injury (SCI) who received it. The investigators also want to find out if zoledronic acid is safe for persons with SCI to take without causing too many side effects.
Read the detailed description
This research study was designed to determine the effects of functional electrical stimulation (FES) rowing and a drug called zoledronic acid in bone health in individuals who have suffered a spinal cord injury (SCI). The investigators hoped to learn if zoledronic acid treatment would increase bone mineral density in persons with chronic spinal cord injury. This was designed and conducted as a three center study with multiple investigators. The investigators also had a goal to find out if zoledronic acid is safe for persons with SCI without causing too many side effects.
The Prime recipient of funding is Spaulding Rehabilitation Hospital (SRH). Dr. Leslie Morse is the Principal Investigator for the study, the coordination of the study was located at Spaulding Rehabilitation Hospital. Through a sub-award a research group from the Veterans Administration of Boston Healthcare System was contracted to conduct DXA scans, blood draws and zoledronic acid administration to support this study. Through another sub-award from SRH, another Investigator from Massachusetts General Hospital (MGH) participated conducting CT scans for the study. All adverse events related to this study were to be monitored and recorded by investigators at SRH.
Seventy subjects age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were enrolled. Enrollment and initial screening for the study and follow up was performed at SRH. After enrollment the subjects were randomized to 1) FES-rowing alone or 2) FES-rowing plus a 1-time infusion of zoledronic acid. Following a variable period of strength training which was necessary for preparing quads and hamstrings for extended FES use, enrolled participants were planned to begin a regular rowing program for 12 months at the Cardiovascular Laboratory at the Spaulding Rehabilitation Hospital . DXA scans to measure bone mineral density were planned to be performed at the VA Boston Healthcare System-Jamaica Plain Campus (VABHS) three times during the study on all participants. In addition, 25 subjects in each arm of the study were planned to receive CT scans of their knees at MGH at the beginning and end of the study. Up to 20 subjects were to have an additional CT scan (at MGH) six months into rowing. Research blood samples were planned to be collected at VABHS five times during duration of the study and stored at the VA for further study of molecular markers of bone turnover. All participants were expected to be screened for renal function and calcium and vitamin D levels at the beginning and end of the study, with additional renal screening done before and after the zoledronic acid infusion. Calcium and vitamin D supplements were to be provided to each subject throughout the study. Those with insufficient vitamin D levels were to be provided additional repletion and planned to be periodically rechecked. Up to 15 male subjects were asked to have two echocardiograms at one of the SRH sites - one at the beginning of the study and the other halfway through the year-long rowing regimen.
- Conditions
- Osteoporosis
- Being tested
- FES-Rowing, Zoledronic acid
- Keywords
- Disorder of Bone Density and Structure, Unspecified, Weakening of the bone structure
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES-RowingOther
Also called Rowing exercise
FES- Rowing Exercise
Zoledronic acidDrug
Also called Reclast
5 mg IV single dose
| Study group | Role | What they receive |
|---|---|---|
| FES Rowing | Active comparator | Group 1 - FES-Rowing Exercise for entire study period Receives: Other: FES-Rowing |
| FES Rowing + Zoledronic acid | Experimental | Group 2 - FES-Rowing Exercise for entire study period plus Zoledronic Acid 5mg administered by i.v. infusion one-time at the end of observation period Receives: Other: FES-Rowing; Drug: Zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Bone Mass as Measured by Sequential Evaluation of Bone Density and Bone Structure
This work was designed to determine if FES-rowing plus Zoledronic acid is superior to FES-rowing alone reversing deterioration and weakening of the bones due to SCI and was planned to confirm the effects of FES-rowing in bone structure in patients not receiving Zoledronic Acid.
Measured: 12 months
Secondary outcomes (1)
Validation of DXA Scanning in Patients With SCI
This study has been designed to evaluate whether sequential DXA scanning of the distal femur and proximal femur is an appropriate clinical tool to monitor bone changes in response to either treatment. Evaluation of bone density by DXA was planned to be compared to CT scans of the distal femur and proximal tibia.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Incomplete data set \& analysis
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 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonio Lazzari
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Spaulding Rehabilitation Hospital, VA Boston Healthcare System, Massachusetts General Hospital
- Responsible party
- Sponsor-investigator, Antonio Lazzari, Boston VA Research Institute, Inc.
- Investigators
- Leslie Morse, DO, Principal investigator, Spaulding Rehab. HospitalAntonio A Lazzari, MD, Principal investigator, Boston Division VAMC - New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426555
- Sponsor's protocol ID
- 109241
- Status last verified
- Mar 2016
- First submitted
- 8 Jun 2011
- Last updated
- 11 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: The study has been closed by the VABHS IRB.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FES-Rowing Versus Zoledronic Acid to Improve Bone Health in SCI: A Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT01426555
- Acronym / sponsor ID
- 109241
- Conditions
- Osteoporosis
- Keywords
- Disorder of Bone Density and Structure, Unspecified, Weakening of the bone structure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Incomplete data set \& analysis
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Antonio LazzariUniversity, hospital or other
- Collaborators
- United States Department of Defense, Spaulding Rehabilitation Hospital, VA Boston Healthcare System, Massachusetts General Hospital
- Study start
- Feb 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 31 Aug 2011 (estimated)
- Results
- Posted 10 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study to determine the effects of functional electrical stimulation (FES) rowing and a drug called zoledronic acid in bone health. The investigators hoped to learn if zoledronic acid treatment will increase bone mineral density in persons with chronic spinal cord injury (SCI) who received it. The investigators also want to find out if zoledronic acid is safe for persons with SCI to take without causing too many side effects.
Detailed description
This research study was designed to determine the effects of functional electrical stimulation (FES) rowing and a drug called zoledronic acid in bone health in individuals who have suffered a spinal cord injury (SCI). The investigators hoped to learn if zoledronic acid treatment would increase bone mineral density in persons with chronic spinal cord injury. This was designed and conducted as a three center study with multiple investigators. The investigators also had a goal to find out if zoledronic acid is safe for persons with SCI without causing too many side effects.
The Prime recipient of funding is Spaulding Rehabilitation Hospital (SRH). Dr. Leslie Morse is the Principal Investigator for the study, the coordination of the study was located at Spaulding Rehabilitation Hospital. Through a sub-award a research group from the Veterans Administration of Boston Healthcare System was contracted to conduct DXA scans, blood draws and zoledronic acid administration to support this study. Through another sub-award from SRH, another Investigator from Massachusetts General Hospital (MGH) participated conducting CT scans for the study. All adverse events related to this study were to be monitored and recorded by investigators at SRH.
Seventy subjects age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were enrolled. Enrollment and initial screening for the study and follow up was performed at SRH. After enrollment the subjects were randomized to 1) FES-rowing alone or 2) FES-rowing plus a 1-time infusion of zoledronic acid. Following a variable period of strength training which was necessary for preparing quads and hamstrings for extended FES use, enrolled participants were planned to begin a regular rowing program for 12 months at the Cardiovascular Laboratory at the Spaulding Rehabilitation Hospital . DXA scans to measure bone mineral density were planned to be performed at the VA Boston Healthcare System-Jamaica Plain Campus (VABHS) three times during the study on all participants. In addition, 25 subjects in each arm of the study were planned to receive CT scans of their knees at MGH at the beginning and end of the study. Up to 20 subjects were to have an additional CT scan (at MGH) six months into rowing. Research blood samples were planned to be collected at VABHS five times during duration of the study and stored at the VA for further study of molecular markers of bone turnover. All participants were expected to be screened for renal function and calcium and vitamin D levels at the beginning and end of the study, with additional renal screening done before and after the zoledronic acid infusion. Calcium and vitamin D supplements were to be provided to each subject throughout the study. Those with insufficient vitamin D levels were to be provided additional repletion and planned to be periodically rechecked. Up to 15 male subjects were asked to have two echocardiograms at one of the SRH sites - one at the beginning of the study and the other halfway through the year-long rowing regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FES Rowing | Active comparator | Other: FES-RowingGroup 1 - FES-Rowing Exercise for entire study period |
| FES Rowing + Zoledronic acid | Experimental | Other: FES-Rowing, Drug: Zoledronic acidGroup 2 - FES-Rowing Exercise for entire study period plus Zoledronic Acid 5mg administered by i.v. infusion one-time at the end of observation period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- male and female SCI outpatients
- women of child bearing age will be required to use an acceptable birth control method throughout the study
- aged 18 - over the age of 40
- physician's cardiac clearance to exercise
- who were at least age 14 at time of injury
Key exclusion criteria (26 listed)
- initial blood pressure higher than 140/90
- patients with orthostatic hypotension
- an active grade 2 or greater pressure ulcers
- lower extremity contractures
- history of significant arrhythmias
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 |
|---|---|---|
| FES-RowingAlso: Rowing exerciseFES- Rowing Exercise | Other | FES Rowing, FES Rowing + Zoledronic acid |
| Zoledronic acidAlso: Reclast5 mg IV single dose | Drug | FES Rowing + Zoledronic acid |
Primary outcome
Improvement of Bone Mass as Measured by Sequential Evaluation of Bone Density and Bone Structure
Time frame: 12 months
This work was designed to determine if FES-rowing plus Zoledronic acid is superior to FES-rowing alone reversing deterioration and weakening of the bones due to SCI and was planned to confirm the effects of FES-rowing in bone structure in patients not receiving Zoledronic Acid.
1 secondary outcome
Validation of DXA Scanning in Patients With SCI
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The study has been closed by the VABHS IRB.
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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.
Leslie Morse, DO principal investigator
Spaulding Rehab. Hospital
Antonio A Lazzari, MD principal investigator
Boston Division VAMC - New England
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing FES-Rowing and Zoledronic acid in people with Osteoporosis, run by Antonio Lazzari 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 7 inclusion and 26 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 11 Apr 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Yes. Results are posted in the registry (first posted 10 Mar 2016). 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?
Improvement of Bone Mass as Measured by Sequential Evaluation of Bone Density and Bone Structure (time frame: 12 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 11 Apr 2016.