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

Primary Purpose

SAPHO Syndrome

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

pamidronate disodium

About this trial

This is an interventional treatment trial for SAPHO Syndrome focused on measuring Treatment, Bisphosphonates, Response rate

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pamidronate disodium

Arm Description

the patients will be administered intravenous pamidronate disodium

Outcomes

Primary Outcome Measures

response to the treatment by the change of MRI result at screening, baseline, month 3 and month 6

Secondary Outcome Measures

physician's global assessment of disease activity at screening, baseline, month 3 and month 6

response to the treatment by the change of Visual Analogue ale/Score (VAS) at screening, baseline, month 3 and month 6

response to the treatment by the change of bath ankylosing spondylitis disease activity index (BASDAI) at screening, baseline, month 3 and month 6

response to the treatment by the change of bath ankylosing spondylitis functional index (BASFI) at screening, baseline, month 3 and month 6

response to the treatment by the change of bath ankylosing spondylitis metroloty index (BASMI) at screening, baseline, month 3 and month 6

response to the treatment by the change of ankylosing spondylitis disease activity score (ASDAS) at screening, baseline, month 3 and month 6

response to the treatment by the change of erythrocyte sedimentation rate (ESR) at screening, baseline, month 3 and month 6

response to the treatment by the change of high sensitivity-C reaction protein (hs-CRP) at screening, baseline, month 3 and month 6

response to the treatment by the change of Osteocalcin at screening, baseline, month 3 and month 6

response to the treatment by the change of beta-Crosslaps (beta-CTx) at screening, baseline, month 3 and month 6

Full Information

NCT ID

NCT02544659

First Posted

August 28, 2015

Last Updated

October 12, 2016

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02544659

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

October 2015 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

5. Study Description

Brief Summary

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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SAPHO Syndrome

Keywords

Treatment, Bisphosphonates, Response rate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pamidronate disodium

Arm Type

Experimental

Arm Description

the patients will be administered intravenous pamidronate disodium

Intervention Type

Drug

Intervention Name(s)

pamidronate disodium

Intervention Description

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 Measure Information:

Title

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 Measure Information:

Title

physician's global assessment of disease activity at screening, baseline, month 3 and month 6

Time Frame