NCT01788176

The Use of Zoledronic Acid to Complex Regional Pain Syndrome

Phase 2 Study - The Use of a Single 5 mg Dose of Zoledronic Acid in Complex Regional Pain Syndrome Patient.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Zoledronic acid	One single dose of 5mg intravenous infusion of zoledronic acid (interventional group)
DRUG	Placebo	one single intravenous infusion of 100ml of saline.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-12-01
• Completion: 2016-12-01
• First posted: 2013-02-11
• Last updated: 2013-02-11

Locations

1 site across 1 country: Brazil