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Completed

NCT Number: NCT02544659

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

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

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Key information

Conditions

SAPHO Syndrome Acquired Hyperostosis Syndrome Bone Diseases Bone Diseases, Developmental Musculoskeletal Diseases Osteochondrodysplasias

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients between the ages of 18 and 70 years
  • 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)
  • MRI shows bone marrow edema in affected site in patients
  • Blood serum of patients show the normal white blood cell count, liver and renal function
  • Patients who like to be followed up for 1 years
  • Other protocol defined inclusion criteria may apply

Exclusion criteria

  • Women in pregnancy or lactation.
  • Septic osteomyelitis
  • Infectious chest wall arthritis
  • Infections PPP
  • Palmo-plantar keratodermia
  • DISH except for fortuitous association
  • Osteoarticular manifestations of retinoid therapy
  • Other protocol defined exclusion criteria may apply

Treatment and study plan

pamidronate disodium

Drug

the patients will be administered pamidronate disodium 1 mg/kg, IV, QD, for 3 days, and every 3 month (up to month 6)

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 9, 2015
Registry last updated
Oct 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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