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

Primary Purpose

Complex Regional Pain Syndromes

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Zoledronic acid
Placebo
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndromes focused on measuring Complex Regional Pain Syndromes, drug therapy, zoledronic acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Saline

Zoledronic acid

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain measured on Visual Analog Scale

Secondary Outcome Measures

Lower Limbs vertical force on Wii platform
American Orthopaedic Foot and Ankle Scale (AOFAS)
36-Item Short Form Health Survey (SF-36)

Full Information

First Posted
October 9, 2012
Last Updated
February 8, 2013
Sponsor
University of Sao Paulo General Hospital
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01788176
Brief Title
The Use of Zoledronic Acid to Complex Regional Pain Syndrome
Acronym
Aclasta
Official Title
Phase 2 Study - The Use of a Single 5 mg Dose of Zoledronic Acid in Complex Regional Pain Syndrome Patient.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndromes
Keywords
Complex Regional Pain Syndromes, drug therapy, zoledronic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
One single intravenous infusion of 100ml of saline (placebo control group).
Arm Title
Zoledronic acid
Arm Type
Active Comparator
Arm Description
one single dose of 5mg intravenous infusion of zoledronic acid (interventional group)
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Intervention Description
One single dose of 5mg intravenous infusion of zoledronic acid (interventional group)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
one single intravenous infusion of 100ml of saline.
Primary Outcome Measure Information:
Title
Pain measured on Visual Analog Scale
Time Frame
up to 12 months after treatment
Secondary Outcome Measure Information:
Title
Lower Limbs vertical force on Wii platform
Time Frame
Baseline, 3, 6 and 12 months
Title
American Orthopaedic Foot and Ankle Scale (AOFAS)
Time Frame
Baseline, 3, 6 and 12 months after treatment
Title
36-Item Short Form Health Survey (SF-36)
Time Frame
Baseline, 3, 6 and 12 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Perola Grinberg Plapler, MD
Phone
55 11 39058512
Email
perolagp@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marta Imamura, MD
Phone
55 11 39058512
Email
martimf3@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linamara R. Battistella, PHD
Organizational Affiliation
Centro de Pesquisa Clínica do Instituto de Medicina Física e de Reabilitação do Hospital das Clínicas da FMUSP
Official's Role
Study Director
Facility Information:
Facility Name
Centro de Pesquisa Clínica do Instituto de Medicina e Reabilitação do HCFMUSP
City
São Paulo
ZIP/Postal Code
05716-150
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pérola G Plapler, MDPhD
Phone
55 11 39058512
Email
perolagp@yahoo.com
First Name & Middle Initial & Last Name & Degree
Marta Imamura, MDPhD
Phone
55 11 39058512
Email
martaimf3@gmail.com
First Name & Middle Initial & Last Name & Degree
Pérola G. Plapler, MDPhD

12. IPD Sharing Statement

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The Use of Zoledronic Acid to Complex Regional Pain Syndrome

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