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

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Saline
One single intravenous infusion of 100ml of saline (placebo control group).
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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)
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Drug: Zoledronic acid
One single dose of 5mg intravenous infusion of zoledronic acid (interventional group) |
- Pain measured on Visual Analog Scale [ Time Frame: up to 12 months after treatment ]
- 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 ]

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

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
Contact: Perola Grinberg Plapler, MD | 55 11 39058512 | perolagp@yahoo.com | |
Contact: Marta Imamura, MD | 55 11 39058512 | martimf3@gmail.com |
Brazil | |
Centro de Pesquisa Clínica do Instituto de Medicina e Reabilitação do HCFMUSP | |
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 |
Study Director: | Linamara R. Battistella, PHD | Centro de Pesquisa Clínica do Instituto de Medicina Física e de Reabilitação do Hospital das Clínicas da FMUSP |
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 |
Other Study ID Numbers: |
CZOL446HBR10T |
First Posted: | February 11, 2013 Key Record Dates |
Last Update Posted: | February 11, 2013 |
Last Verified: | February 2013 |
Complex Regional Pain Syndromes drug therapy zoledronic acid |
Complex Regional Pain Syndromes Reflex Sympathetic Dystrophy Syndrome Somatoform Disorders 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 |