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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Pérola Grinberg Plapler, University of Sao Paulo General Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01788176
First Posted: February 11, 2013
Last Update Posted: February 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by (Responsible Party):
Pérola Grinberg Plapler, University of Sao Paulo General Hospital
October 9, 2012
February 11, 2013
February 11, 2013
December 2013
December 2015   (Final data collection date for primary outcome measure)
Pain measured on Visual Analog Scale [ Time Frame: up to 12 months after treatment ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Complex Regional Pain Syndromes
  • 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.
  • Placebo Comparator: Saline
    One single intravenous infusion of 100ml of saline (placebo control group).
    Intervention: Drug: Placebo
  • Active Comparator: Zoledronic acid
    one single dose of 5mg intravenous infusion of zoledronic acid (interventional group)
    Intervention: Drug: Zoledronic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
December 2016
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01788176
CZOL446HBR10T
No
Not Provided
Not Provided
Pérola Grinberg Plapler, University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
Novartis
Study Director: Linamara R. Battistella, PHD Centro de Pesquisa Clínica do Instituto de Medicina Física e de Reabilitação do Hospital das Clínicas da FMUSP
University of Sao Paulo General Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP