NCT02544659

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 13, 2016

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

August 28, 2015

Last Update Submit

October 12, 2016

Conditions

SAPHO Syndrome

Keywords

TreatmentBisphosphonatesResponse rate

Outcome Measures

Primary Outcomes (1)

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

    3 and 6 month (up to 6 month)

Secondary Outcomes (10)

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

    3 days, 3 and 6 month (up to 6 month)

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

    3 days, 3 and 6 month (up to 6 month)

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

    3 days, 3 and 6 month (up to 6 month)

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

    3 days, 3 and 6 month (up to 6 month)

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

    3 days, 3 and 6 month (up to 6 month)

  • +5 more secondary outcomes

Study Arms (1)

pamidronate disodium

EXPERIMENTAL

the patients will be administered intravenous pamidronate disodium

Drug: pamidronate disodium

Interventions

pamidronate disodiumDRUG

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

pamidronate disodium

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients between the ages of 18 and 70 years
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acquired Hyperostosis Syndrome

Interventions

Pamidronate

Condition Hierarchy (Ancestors)

OsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Chen Li, Master

    Department of Traditional Chinese Medicine, Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2015

First Posted

September 9, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 13, 2016

Record last verified: 2015-09