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The Use of Zoledronic Acid to Complex Regional Pain Syndrome (Aclasta)

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ClinicalTrials.gov Identifier: NCT01788176
Recruitment Status : Unknown
Verified February 2013 by Pérola Grinberg Plapler, University of Sao Paulo General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 11, 2013
Last Update Posted : February 11, 2013
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Pérola Grinberg Plapler, University of Sao Paulo General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndromes Drug: Zoledronic acid Drug: Placebo Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2 Study - The Use of a Single 5 mg Dose of Zoledronic Acid in Complex Regional Pain Syndrome Patient.
Study Start Date : December 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Saline
One single intravenous infusion of 100ml of saline (placebo control group).
 Drug: Placebo
one single intravenous infusion of 100ml of saline.
Active Comparator: Zoledronic acid
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)


Outcome Measures
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Primary Outcome Measures :
  1. Pain measured on Visual Analog Scale [ Time Frame: up to 12 months after treatment ]

Secondary Outcome Measures :
  1. Lower Limbs vertical force on Wii platform [ Time Frame: Baseline, 3, 6 and 12 months ]
  2. American Orthopaedic Foot and Ankle Scale (AOFAS) [ Time Frame: Baseline, 3, 6 and 12 months after treatment ]
  3. 36-Item Short Form Health Survey (SF-36) [ Time Frame: Baseline, 3, 6 and 12 months after treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients over 18 years of age of both genders, with continuing pain that is disproportionate to any inciting event, with cardinal features of CRPS.
  2. Pain - after initial injury with signs and symptoms present at first visit
  3. 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.

  4. Must report at least one symptom in three of the four following categories:

    1. Sensory: Reports of hyperesthesia and/or allodynia
    2. Vasomotor: Reports of temperature asymmetry and/or skin color changes and/or skin color asymmetry
    3. Sudomotor/Edema: Reports of edema and/or sweating changes and/or sweating asymmetry
    4. Motor/Trophic: Reports of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin).

  5. Must display at least one sign* at time of evaluation in two or more of the following categories:

    1. Sensory: Evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch and/or deep somatic pressure and/or joint movement)
    2. Vasomotor: Evidence of temperature asymmetry and/or skin color changes and/or asymmetry
    3. Sudomotor/Edema: Evidence of edema and/or sweating changes and/or sweating asymmetry
    4. Motor/Trophic: Evidence of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin).
  6. Skin temperature of the affected side equal or higher than on the non-affected side.
  7. No other diagnosis better explains the signs and symptoms.

Exclusion Criteria:

  1. 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.
  2. Creatinine clearance <35mL/min, with serum creatinine measured before the dose of zoledronic acid.
  3. Pre-existing hypocalcaemia and disturbance of mineral metabolism (e.g. hyperparathyroidism, thyroid surgery, parathyroid surgery, malabsorption syndromes, and excision of small intestine).
  4. Hypersensitivity to zoledronic acid or any component drugs used in the trial.
  5. Patients with asthma and aspirin-sensitivity
  6. Pregnancy or unwillingness to use contraceptive methods during the trial
  7. Patients who have previously used any kind of bisphosphonate, especially zoledronic acid.
  8. Osteoporosis
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788176


Contacts
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Contact: Perola Grinberg Plapler, MD 55 11 39058512 perolagp@yahoo.com
Contact: Marta Imamura, MD 55 11 39058512 martimf3@gmail.com

Locations
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Brazil
Centro de Pesquisa Clínica do Instituto de Medicina e Reabilitação do HCFMUSP Not yet recruiting
São Paulo, Brazil, 05716-150
Contact: Pérola G Plapler, MDPhD    55 11 39058512    perolagp@yahoo.com   
Contact: Marta Imamura, MDPhD    55 11 39058512    martaimf3@gmail.com   
Principal Investigator: Pérola G. Plapler, MDPhD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Novartis
Investigators
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Study Director: Linamara R. Battistella, PHD Centro de Pesquisa Clínica do Instituto de Medicina Física e de Reabilitação do Hospital das Clínicas da FMUSP
More Information
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Responsible Party: Pérola Grinberg Plapler, MD, PhD, Director of Physical Medicine Division Of Institute Orthopedics and Traumatology of University of Sao Paulo General Hospital, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01788176     History of Changes
Other Study ID Numbers: CZOL446HBR10T
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: February 2013

Keywords provided by Pérola Grinberg Plapler, University of Sao Paulo General Hospital:
Complex Regional Pain Syndromes
drug therapy
zoledronic acid

Additional relevant MeSH terms:
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Syndrome
Somatoform Disorders
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Disease
Pathologic Processes
Mental Disorders
 Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs