Complex Regional Pain SyndromesPhase 2AclastaNCT01788176
The Use of Zoledronic Acid to Complex Regional Pain Syndrome
A Phase 2 study testing Zoledronic acid in people with Complex Regional Pain Syndromes, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
To evaluate the efficacy and the safety of using a single, intravenous 5mg dose of zoledronic acid in managing pain in Complex Regional Pain Syndrome patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Regional Pain Syndromes
- What is being tested?
- Zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2013to Dec 2016
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age of both genders, with continuing pain that is disproportionate to any inciting event, with cardinal features of CRPS.
- Pain - after initial injury with signs and symptoms present at first visit
- History of previous unsuccessful treatment for pain, with a minimum of two drug therapies, such as non steroidal anti-inflammatory drugs, steroids, antidepressants, central acting analgesics, calcitonin or sympathetic blocks, (not bisphosphonates) for at least six months.
- Must report at least one symptom in three of the four following categories:
- Sensory: Reports of hyperesthesia and/or allodynia
- Vasomotor: Reports of temperature asymmetry and/or skin color changes and/or skin color asymmetry
Show all 15Show fewer
- Sudomotor/Edema: Reports of edema and/or sweating changes and/or sweating asymmetry
- Motor/Trophic: Reports of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin).
- Must display at least one sign* at time of evaluation in two or more of the following categories:
- Sensory: Evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch and/or deep somatic pressure and/or joint movement)
- Vasomotor: Evidence of temperature asymmetry and/or skin color changes and/or asymmetry
- Sudomotor/Edema: Evidence of edema and/or sweating changes and/or sweating asymmetry
- Motor/Trophic: Evidence of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin).
- Skin temperature of the affected side equal or higher than on the non-affected side.
- No other diagnosis better explains the signs and symptoms.
Who cannot join
- Presence of systemic diseases including diabetes mellitus, hyperthyroidism, renal and liver dysfunction, peripheral vascular or cardiovascular diseases, uncontrolled hypertension, rheumatoid and hematopoietic diseases, neurological diseases not related to CRPS, overt alcohol addiction, positive pregnancy test and/or lactating women, hyperparathyroidism, and hypocalcaemia.
- Creatinine clearance <35mL/min, with serum creatinine measured before the dose of zoledronic acid.
- Pre-existing hypocalcaemia and disturbance of mineral metabolism (e.g. hyperparathyroidism, thyroid surgery, parathyroid surgery, malabsorption syndromes, and excision of small intestine).
- Hypersensitivity to zoledronic acid or any component drugs used in the trial.
- Patients with asthma and aspirin-sensitivity
- Pregnancy or unwillingness to use contraceptive methods during the trial
- Patients who have previously used any kind of bisphosphonate, especially zoledronic acid.
- Osteoporosis
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Pesquisa Clínica do Instituto de Medicina e Reabilitação do HCFMUSP
São Paulo, São Paulo, 05716-150
Pérola G Plapler, MDPhD, 55 11 39058512, perolagp@yahoo.com
Marta Imamura, MDPhD, 55 11 39058512, martaimf3@gmail.com
About this study
Official title: Phase 2 Study - The Use of a Single 5 mg Dose of Zoledronic Acid in Complex Regional Pain Syndrome Patient.
To evaluate the efficacy and the safety of using a single, intravenous 5mg dose of zoledronic acid in managing pain in Complex Regional Pain Syndrome patients.
Read the detailed description
Complex regional pain syndrome (CRPS) is a disorder of the extremities that is characterized by spontaneous unexplained disproportionate pain, hyperalgesia, swelling, limited range of motion, vasomotor instability, skin changes, and patchy bone demineralization.The incidence of CRPS was estimated to be 5.46 per 100,000 person years at risk in Olmsted County, Minnesota (US), with a prevalence of 20.57 per 100,000, while its incidence in the general population of the Netherlands was estimated to be much higher, at 26.2 per 100,000 person-years. The adverse effects were not serious and lasted just a few days. The beneficial effects of other bisphosphonates have been already documented in several placebo-controlled trials; however, there are no reports on the use of zoledronic acid to reduce pain in CRPS patients.
- Conditions
- Complex Regional Pain Syndromes
- Being tested
- Zoledronic acid, Placebo
- Keywords
- Complex Regional Pain Syndromes, drug therapy, zoledronic acid
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
One single dose of 5mg intravenous infusion of zoledronic acid (interventional group)
PlaceboDrug
one single intravenous infusion of 100ml of saline.
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | One single intravenous infusion of 100ml of saline (placebo control group). Receives: Drug: Placebo |
| Zoledronic acid | Active comparator | one single dose of 5mg intravenous infusion of zoledronic acid (interventional group) Receives: Drug: Zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured on Visual Analog Scale
Measured: up to 12 months after treatment
Secondary outcomes (3)
Lower Limbs vertical force on Wii platform
Measured: Baseline, 3, 6 and 12 months
American Orthopaedic Foot and Ankle Scale (AOFAS)
Measured: Baseline, 3, 6 and 12 months after treatment
36-Item Short Form Health Survey (SF-36)
Measured: Baseline, 3, 6 and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain SyndromesStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Pérola Grinberg Plapler, University of Sao Paulo General Hospital
- Investigators
- Linamara R. Battistella, PHD, Study director, Centro de Pesquisa Clínica do Instituto de Medicina Física e de Reabilitação do Hospital das Clínicas da FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788176
- Sponsor's protocol ID
- CZOL446HBR10T
- Acronym
- Aclasta
- Status last verified
- Feb 2013
- First submitted
- 9 Oct 2012
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study - The Use of a Single 5 mg Dose of Zoledronic Acid in Complex Regional Pain Syndrome Patient.
- ClinicalTrials.gov ID
- NCT01788176
- Acronym / sponsor ID
- Aclasta / CZOL446HBR10T
- Conditions
- Complex Regional Pain Syndromes
- Keywords
- Complex Regional Pain Syndromes, drug therapy, zoledronic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Feb 2013 (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.
To evaluate the efficacy and the safety of using a single, intravenous 5mg dose of zoledronic acid in managing pain in Complex Regional Pain Syndrome patients.
Detailed description
Complex regional pain syndrome (CRPS) is a disorder of the extremities that is characterized by spontaneous unexplained disproportionate pain, hyperalgesia, swelling, limited range of motion, vasomotor instability, skin changes, and patchy bone demineralization.The incidence of CRPS was estimated to be 5.46 per 100,000 person years at risk in Olmsted County, Minnesota (US), with a prevalence of 20.57 per 100,000, while its incidence in the general population of the Netherlands was estimated to be much higher, at 26.2 per 100,000 person-years. The adverse effects were not serious and lasted just a few days. The beneficial effects of other bisphosphonates have been already documented in several placebo-controlled trials; however, there are no reports on the use of zoledronic acid to reduce pain in CRPS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Drug: PlaceboOne single intravenous infusion of 100ml of saline (placebo control group). |
| Zoledronic acid | Active comparator | Drug: Zoledronic acidone single dose of 5mg intravenous infusion of zoledronic acid (interventional group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients over 18 years of age of both genders, with continuing pain that is disproportionate to any inciting event, with cardinal features of CRPS.
- Pain - after initial injury with signs and symptoms present at first visit
- History of previous unsuccessful treatment for pain, with a minimum of two drug therapies, such as non steroidal anti-inflammatory drugs, steroids, antidepressants, central acting analgesics, calcitonin or sympathetic blocks, (not bisphosphonates) for at least six months.
- Must report at least one symptom in three of the four following categories:
- Must display at least one sign* at time of evaluation in two or more of the following categories:
Key exclusion criteria (8 listed)
- Presence of systemic diseases including diabetes mellitus, hyperthyroidism, renal and liver dysfunction, peripheral vascular or cardiovascular diseases, uncontrolled hypertension, rheumatoid and hematopoietic diseases, neurological diseases not related to CRPS, overt alcohol addiction, positive pregnancy test and/or lactating women, hyperparathyroidism, and hypocalcaemia.
- Creatinine clearance <35mL/min, with serum creatinine measured before the dose of zoledronic acid.
- Pre-existing hypocalcaemia and disturbance of mineral metabolism (e.g. hyperparathyroidism, thyroid surgery, parathyroid surgery, malabsorption syndromes, and excision of small intestine).
- Hypersensitivity to zoledronic acid or any component drugs used in the trial.
- Patients with asthma and aspirin-sensitivity
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 |
|---|---|---|
| Zoledronic acidOne single dose of 5mg intravenous infusion of zoledronic acid (interventional group) | Drug | Zoledronic acid |
| Placeboone single intravenous infusion of 100ml of saline. | Drug | Saline |
Primary outcome
Pain measured on Visual Analog Scale
Time frame: up to 12 months after treatment
3 secondary outcomes
Lower Limbs vertical force on Wii platform
Time frame: Baseline, 3, 6 and 12 months
American Orthopaedic Foot and Ankle Scale (AOFAS)
Time frame: Baseline, 3, 6 and 12 months after treatment
36-Item Short Form Health Survey (SF-36)
Time frame: Baseline, 3, 6 and 12 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
Related trials for Complex Regional Pain Syndromes
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 3
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Complex Regional Pain Syndrome Type I
Recruiting
The Effectiveness of Conservative Treatment in Patients With Complex Regional Pain Syndrome.
CRPS (Complex Regional Pain Syndromes)
RecruitingPhase 3
Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1
Complex Regional Pain Syndrome Type I
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
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.
Linamara R. Battistella, PHD study director
Centro de Pesquisa Clínica do Instituto de Medicina Física e de Reabilitação do Hospital das Clínicas da FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zoledronic acid in people with Complex Regional Pain Syndromes, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 15 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: status not confirmed, as of the sponsor's last update on 11 Feb 2013. 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 Brazil. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Perola Grinberg Plapler, MD (55 11 39058512, perolagp@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measured on Visual Analog Scale (time frame: up to 12 months after treatment). 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 Feb 2013.