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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52471

Enrollment

Registered

2020-11-10

Start date

2020-12-08

Completion date

Unknown

Last updated

2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SAPHO-syndrome sterile bone inflammation

Interventions

Pamidronate infusion 30 mg/day (diluted in 0.9% saline) or placebo (0.9% saline) on 3 consecutive days, at start of the study and after 3 months (double blind randomized phase) and possibly during o

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Change in score of maximal pain on BPI (VAS 0-10) from baseline to 6 months .	—

Secondary

Measure	Time frame
• Change in range of motion • Number of patients with mild pain (maximal pain as measured with NRS score in BPI 4 or below) • Number of patients with 50% reduction in maximal pain (NRS score in BPI) • Change in shoulder rating questionnaire11 and facets of SFA score12 (among which are ability to dress) • Change in general health, quality of life, fatigue, work activity score, physical activity, and partner burden • Change in standard dose of analgesics (including NSAIDs) possible during course of the study as evidence for efficacy of treatment. • Evaluation of confounding factors for outcome of treatment such as delay in diagnosis and the amount of baseline tracer uptake, pain and range of motion • Evaluation of a possible neuropathic component of the reported pain • Number of SCCH patients exhibiting signs of central sensitization • Association between central sensitization and therapeutic response • Change in biochemical markers of inflammation • Amount of tracer uptake of CNO lesions on Na18F-PET/CT • Cost-effectiveness • Spinal involvement	—

Measure

Time frame

• Change in range of motion • Number of patients with mild pain (maximal pain as measured with NRS score in BPI 4 or below) • Number of patients with 50% reduction in maximal pain (NRS score in BPI) • Change in shoulder rating questionnaire11 and facets of SFA score12 (among which are ability to dress) • Change in general health, quality of life, fatigue, work activity score, physical activity, and partner burden • Change in standard dose of analgesics (including NSAIDs) possible during course of the study as evidence for efficacy of treatment. • Evaluation of confounding factors for outcome of treatment such as delay in diagnosis and the amount of baseline tracer uptake, pain and range of motion • Evaluation of a possible neuropathic component of the reported pain • Number of SCCH patients exhibiting signs of central sensitization • Association between central sensitization and therapeutic response • Change in biochemical markers of inflammation • Amount of tracer uptake of CNO lesions on Na18F-PET/CT • Cost-effectiveness • Spinal involvement

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)