Pamidronate for adult CNO

Phase 1

• Conditions: Chronic nonbacterial osteitis (CNO) in adults; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2020-001068-27-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-27
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Adult patients with an established diagnosis of CNO based on clinical and imaging features.
- NRS score for maximal pain of 6/10 or higher at lesion sites*
- Signs of disease activity on imaging at lesion sites
- No treatment with bisphosphonates for the previous 6 months **

* If the patient uses co-medication possibly targeting CNO-related pain, i.e. paracetamol, NSAIDs, opioids, DMARDs and biologicals on stable dosage, score for maximal pain should be 6/10 or higher despite the use of these medication(s) . Co-medication can be continued throughout the study and will be periodically monitored by the researcher.
**For bisphosphonates, a pre-specified wash-out period of 6 months is indicated before inclusion in the study. Biologicals and steroids that are discontinued in a regular care setting (so not continued as co-medication) prior to inclusion in the study also require a pre-specified wash-out period prior to inclusion (as specified in Standard Operating Procedure Washout Periods).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 68
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

- Age below 18 years of age
- Active pregnancy wish, pregnancy or nursing
- Generalized pain without CNO related pain
- Bisphosphonate allergy
- Estimated glomerular filtration rate < 30 ml/min
- Uncontrolled endocrine abnormalities
- Active cancer treatment.
- Language barrier
- Severe co-morbidity, including poor mobility and other causes preventing attendance for control visits
- Mental disability
NB: 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 clinical trial of medicinal product
• Study Design: Not specified