Efficacy of Bisphosphonates in Patients With Synovitis, A... | NCT02544659

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

NCT02544659

Sponsor

Peking Union Medical College Hospital

Status

Completed

Last Update Posted

Oct 13, 2016Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

SAPHO Syndrome

Interventions

pamidronate disodium

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Aug 28, 2015

First Submission Date that Met QC Criteria

Sep 8, 2015

First Posted Date

Sep 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2016

Last Update Posted Date

Oct 13, 2016Estimated

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pamidronate disodium	Experimental	the patients will be administered intravenous pamidronate disodium	Drug: pamidronate disodium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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)	pamidronate disodium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010009	Osteochondrodysplasias
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals