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Efficacy of Bisphosphonates in Patients With Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis (SAPHO) Syndrome

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.
 
ClinicalTrials.gov Identifier: NCT02544659
Recruitment Status : Completed
First Posted : September 9, 2015
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
This study is designed to evaluate long term efficacy of intravenous bisphosphonates for bone marrow edema in patients with SAPHO syndrome.

Condition or disease Intervention/treatment Phase
SAPHO Syndrome Drug: pamidronate disodium Phase 1

Detailed Description:
The study will evaluate the long term efficacy at 3 days, 3 and 6 months after pamidronate disodium administered. Patients will be administered pamidronate disodium 1 mg/kg, IV, QD, for 3 days, and every 3 months (up to month 6).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Unrandomized, Open Label Single-center Study to Assess the Long Term Efficacy of Intravenous Bisphosphonates for Bone Marrow Edema in Patients With SAPHO Syndrome
Study Start Date : October 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016


Arm Intervention/treatment
Experimental: pamidronate disodium
the patients will be administered intravenous pamidronate disodium
Drug: pamidronate disodium
the patients will be administered pamidronate disodium 1 mg/kg, IV, QD, for 3 days, and every 3 month (up to month 6)




Primary Outcome Measures :
  1. response to the treatment by the change of MRI result at screening, baseline, month 3 and month 6 [ Time Frame: 3 and 6 month (up to 6 month) ]

Secondary Outcome Measures :
  1. physician's global assessment of disease activity at screening, baseline, month 3 and month 6 [ Time Frame: 3 days, 3 and 6 month (up to 6 month) ]
  2. response to the treatment by the change of Visual Analogue ale/Score (VAS) at screening, baseline, month 3 and month 6 [ Time Frame: 3 days, 3 and 6 month (up to 6 month) ]
  3. response to the treatment by the change of bath ankylosing spondylitis disease activity index (BASDAI) at screening, baseline, month 3 and month 6 [ Time Frame: 3 days, 3 and 6 month (up to 6 month) ]
  4. response to the treatment by the change of bath ankylosing spondylitis functional index (BASFI) at screening, baseline, month 3 and month 6 [ Time Frame: 3 days, 3 and 6 month (up to 6 month) ]
  5. response to the treatment by the change of bath ankylosing spondylitis metroloty index (BASMI) at screening, baseline, month 3 and month 6 [ Time Frame: 3 days, 3 and 6 month (up to 6 month) ]
  6. response to the treatment by the change of ankylosing spondylitis disease activity score (ASDAS) at screening, baseline, month 3 and month 6 [ Time Frame: 3 days, 3 and 6 month (up to 6 month) ]
  7. response to the treatment by the change of erythrocyte sedimentation rate (ESR) at screening, baseline, month 3 and month 6 [ Time Frame: 3 days, 3 and 6 month (up to 6 month) ]
  8. response to the treatment by the change of high sensitivity-C reaction protein (hs-CRP) at screening, baseline, month 3 and month 6 [ Time Frame: 3 days, 3 and 6 month (up to 6 month) ]
  9. response to the treatment by the change of Osteocalcin at screening, baseline, month 3 and month 6 [ Time Frame: 3 days, 3 and 6 month (up to 6 month) ]
  10. response to the treatment by the change of beta-Crosslaps (beta-CTx) at screening, baseline, month 3 and month 6 [ Time Frame: 3 days, 3 and 6 month (up to 6 month) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients between the ages of 18 and 70 years
  2. Only 1 of the 4 inclusion criteria is sufficient to arrive at a diagnosis of SAPHO syndrome:

    • Osteo-articular manifestations of acne conglobata, acne fulminans, or hidradenitis suppurativa
    • Osteo-articular manifestations of PPP
    • Hyperostosis (of the anterior chest wall, limbs or spine) with or without dermatosis
    • CRMO involving the axial or peripheral skeleton with or without dermatosis Palmoplantar pustulosis(PPP); chronic recurrent multifocal osteomyelitis(CRMO)
  3. MRI shows bone marrow edema in affected site in patients
  4. Blood serum of patients show the normal white blood cell count, liver and renal function
  5. Patients who like to be followed up for 1 years
  6. Other protocol defined inclusion criteria may apply

Exclusion Criteria:

  1. Women in pregnancy or lactation.
  2. Septic osteomyelitis
  3. Infectious chest wall arthritis
  4. Infections PPP
  5. Palmo-plantar keratodermia
  6. DISH except for fortuitous association
  7. Osteoarticular manifestations of retinoid therapy
  8. Other protocol defined exclusion criteria may apply

Information from the National Library of Medicine

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): NCT02544659


Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Chen Li, Master Department of Traditional Chinese Medicine, Peking Union Medical College Hospital
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02544659    
Other Study ID Numbers: PUMCH-SAPHO-01
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: September 2015
Keywords provided by Peking Union Medical College Hospital:
Treatment
Bisphosphonates
Response rate
Additional relevant MeSH terms:
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Acquired Hyperostosis Syndrome
Syndrome
Disease
Pathologic Processes
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Pamidronate
Bone Density Conservation Agents
Physiological Effects of Drugs