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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 1

Conditions: SAPHO Syndrome

Treatments: Drug: pamidronate disodium

Study type: Interventional

Funder types: Other

Identifiers

NCT02544659

PUMCH-SAPHO-01

Details and patient eligibility

About

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

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

pamidronate disodium

Experimental group

Description:

the patients will be administered intravenous pamidronate disodium

Treatment:

Drug: pamidronate disodium