Pamidronate for pain in adult chronic nonbacterial osteitis (PAM-CNO): a randomized, double-blind, placebo-controlled trial

Phase 3

Recruiting

• Conditions: SAPHO-syndrome; sterile bone inflammation; 10005959

• Registration Number: NL-OMON52471
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

Adult patients (> 18 years of age or older) with an established diagnosis of
CNO based on clinical imaging features with a reported maximum pain score of
6/10 or higher and signs of active disease on imaging, and no treatment with
bisphosphonates for the previous 6 months, and willing to participate.

Exclusion Criteria

Patients who are under 18 years of age will be excluded. Active pregnancy wish,
pregnancy or nursing are exclusion criteria. Patients with generalized pain
without CNO-related pain are excluded. Bisphosphonate use during previous 6
months before study entry, bisphosphonate allergy, estimated glomerular
filtration rate < 30 ml/min, uncontrolled endocrine abnormalities, and active
cancer treatment are exclusion criteria. Patients will not be included in the
study in case of language barrier, severe co-morbidity, including poor mobility
and other causes preventing attendance for control visits, as are mentally
disabled patients. In case of poor dental hygiene or inadequate dental care,
patients will only be enrolled after oral maxillary surgeon consultation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in score of maximal pain on BPI (VAS 0-10) from baseline to 6 months .</p><br>