A Phase 2 interventional study of Zoledronic acid and Placebo in Complex Regional Pain Syndromes, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-11.
Sponsored by University of Sao Paulo General Hospital · Phase 2, Interventional, and Treatment
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.
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.
198 studies on the registry are indexed under Complex Regional Pain Syndromes; 55 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 146 interventional studies indexed under Complex Regional Pain Syndromes.
Browse Complex Regional Pain Syndromes studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
One single intravenous infusion of 100ml of saline (placebo control group).
Drug: Placebo
one single dose of 5mg intravenous infusion of zoledronic acid (interventional group)
Drug: Zoledronic acid
One single dose of 5mg intravenous infusion of zoledronic acid (interventional group)
one single intravenous infusion of 100ml of saline.
Pain measured on Visual Analog Scale
Time frame: up to 12 months after treatment
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
This study is status unknown, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Complex Regional Pain Syndromes→
University of Sao Paulo General Hospital