The Use of Zoledronic Acid to Complex Regional Pain Syndrome

NCT01788176 | Unknown Phase 2

• 1 other identifier: CZOL446HBR10T
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Complex Regional Pain Syndromes

Keywords

Complex Regional Pain Syndromes; drug therapy; zoledronic acid

Outcome Measures

Primary Outcomes (1)

• Pain measured on Visual Analog Scale

  up to 12 months after treatment

Secondary Outcomes (3)

• Lower Limbs vertical force on Wii platform

  Baseline, 3, 6 and 12 months

• American Orthopaedic Foot and Ankle Scale (AOFAS)

  Baseline, 3, 6 and 12 months after treatment

• 36-Item Short Form Health Survey (SF-36)

  Baseline, 3, 6 and 12 months after treatment

Study Arms (2)

Saline

PLACEBO COMPARATOR

One single intravenous infusion of 100ml of saline (placebo control group).

Drug: Placebo

Zoledronic acid

ACTIVE COMPARATOR

one single dose of 5mg intravenous infusion of zoledronic acid (interventional group)

Drug: Zoledronic acid

Interventions

Zoledronic acid DRUG

One single dose of 5mg intravenous infusion of zoledronic acid (interventional group)

Zoledronic acid

Placebo DRUG

one single intravenous infusion of 100ml of saline.

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Novartis: collaborator

Study Sites (1)

Centro de Pesquisa Clínica do Instituto de Medicina e Reabilitação do HCFMUSP

São Paulo, São Paulo, 05716-150, Brazil

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Linamara R. Battistella, PHD

  Centro de Pesquisa Clínica do Instituto de Medicina Física e de Reabilitação do Hospital das Clínicas da FMUSP

  STUDY DIRECTOR

Central Study Contacts

Perola Grinberg Plapler, MD

CONTACT

55 11 39058512; perolagp@yahoo.com

Marta Imamura, MD

CONTACT

55 11 39058512; martimf3@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Director of Physical Medicine Division Of Institute Orthopedics and Traumatology of University of Sao Paulo General Hospital

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: February 11, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: February 11, 2013

Record last verified: 2013-02

Locations

BR (1)