Pamidronate for pain in adult chronic nonbacterial osteitis: protocol of a randomized, double-blind, placebo-controlled trial.

Autor:	Leerling AT; Department of Internal Medicine, Division of Endocrinology, Leiden University Medical Center, Leiden, 2333 ZA, the Netherlands.; Center for Bone Quality, Leiden University Medical Center, Leiden, 2333 ZA, the Netherlands.; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, 2333 ZA, the Netherlands., Cañete AN; Center for Bone Quality, Leiden University Medical Center, Leiden, 2333 ZA, the Netherlands.; Department of Radiology, section of Nuclear Medicine, Leiden University Medical Center, Leiden, ZA 2333, the Netherlands., Smit F; Center for Bone Quality, Leiden University Medical Center, Leiden, 2333 ZA, the Netherlands.; Department of Radiology, section of Nuclear Medicine, Leiden University Medical Center, Leiden, ZA 2333, the Netherlands.; Department of Nuclear Medicine, Alrijne Hospital, Leiderdorp, 2353 GA, the Netherlands., Hamdy NAT; Department of Internal Medicine, Division of Endocrinology, Leiden University Medical Center, Leiden, 2333 ZA, the Netherlands.; Center for Bone Quality, Leiden University Medical Center, Leiden, 2333 ZA, the Netherlands., van de Burgt A; Department of Nuclear Medicine, Alrijne Hospital, Leiderdorp, 2353 GA, the Netherlands., Appelman-Dijkstra NM; Department of Internal Medicine, Division of Endocrinology, Leiden University Medical Center, Leiden, 2333 ZA, the Netherlands.; Center for Bone Quality, Leiden University Medical Center, Leiden, 2333 ZA, the Netherlands., Dekkers OM; Department of Internal Medicine, Division of Endocrinology, Leiden University Medical Center, Leiden, 2333 ZA, the Netherlands.; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, 2333 ZA, the Netherlands., Winter EM; Department of Internal Medicine, Division of Endocrinology, Leiden University Medical Center, Leiden, 2333 ZA, the Netherlands.; Center for Bone Quality, Leiden University Medical Center, Leiden, 2333 ZA, the Netherlands.
Jazyk:	angličtina
Zdroj:	JBMR plus [JBMR Plus] 2024 Aug 27; Vol. 8 (10), pp. ziae114. Date of Electronic Publication: 2024 Aug 27 (Print Publication: 2024).
DOI:	10.1093/jbmrpl/ziae114
Abstrakt:	Chronic nonbacterial osteitis (CNO) is a rare auto-inflammatory bone disease affecting children and adults. Adult CNO is characterized by painful bone lesions, primarily of the anterior chest wall. There is no approved therapy for adult CNO. Current off-label treatments include intravenous bisphosphonates, which have been shown to alleviate pain through decreasing bone turnover. However, no adequately powered randomized controlled trials (RCTs) have been conducted. This double-blind, placebo-controlled RCT investigates the efficacy of intravenous pamidronate to decrease bone pain in adult CNO patients. Recruiting at the Dutch national referral center for CNO, adult patients with persistent bone pain despite non-steroidal anti-inflammatory drugs, or optionally other standard-of-care treatments are randomized to receive two courses of intravenous pamidronate (at 0 and 3 mo, 30 mg daily, on 3 consecutive d) or placebo. From 6 mo onwards, all patients receive open-label pamidronate for another two courses. The primary outcome is change in score for maximum pain from 0 to 6 mo. Secondary outcomes include change in quantitative intralesional bone turnover as measured on sodium-fluoride positron emission computed tomography ([ 18 F]NaF-PET/CT), inflammation markers, shoulder function, general health, quality of life, fatigue, physical, and work activity. The pamidronate for pain in adult chronic nonbacterial osteitis trial addresses the need for evidence-based treatments in adult CNO. Results will directly impact daily clinical practice, either validating the use of intravenous pamidronate in CNO at the dose used in this trial or prompting the search for alternative regimens or agents. This trial was registered in EudraCT (reference 2020-001068-27) and the Dutch Trial Register (reference NL68020.058.20). Competing Interests: The authors declare that they have no competing interests. (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Society for Bone and Mineral Research.)
Databáze:	MEDLINE
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