Malignant transformation in patients with monoclonal gammopathy of undetermined significance treated with teriparatide for osteoporosis: a bicenter retrospective study and analysis of the French national pharmacovigilance database

IF 2.7 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Archives of Osteoporosis Pub Date : 2026-03-29 DOI:10.1007/s11657-026-01693-x

R. Cassez, B. Cortet, B. Bouvard, D. Theis, C. Potey, S. Manier, J. Paccou, C. Philippoteaux

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引用次数: 0

Abstract

Summary

Malignant transformation in patients with monoclonal gammopathy of undetermined significance treated with teriparatide was evaluated. Among 29 patients, only two progressed to hematologic malignancy (one multiple myeloma, one Waldenström’s macroglobulinemia). These findings are reassuring and suggest that TPT may remain an option for selected patients with severe osteoporosis and MGUS.

Purpose

Osteoporosis is a highly prevalent bone disease with limited therapeutic options, particularly in multimorbid patients. Monoclonal gammopathy of undetermined significance (MGUS), a frequent finding in osteoporosis and a recognized fracture risk factor, often leads to contraindication of teriparatide (TPT), further restricting treatment choices. This study aimed to assess hematologic malignant transformation in osteoporotic patients with MGUS treated with TPT.

Methods

A retrospective bicenter observational study was conducted at Lille and Angers University Hospitals (2016–2022). Patients with osteoporosis and confirmed MGUS at TPT initiation were included. Demographic, hematologic, bone, and treatment parameters were collected. In parallel, hematologic malignancies reported with TPT were reviewed from the French national pharmacovigilance database (PVDB) over the same period.

Results

Twenty-nine patients (69% women; mean age 72.6 ± 12.6 years) were included. Most had major comorbidities (89.7% with Charlson Comorbidity Index ≥ 3). MGUS was IgG-type in 55.2% and IgM-type in 41.4%. The mean follow-up from TPT initiation was 60.2 ± 30.7 months (median 54.0; 95% CI 49.0–71.4). Two patients developed hematologic malignancy: one multiple myeloma (MM) 7 years after TPT and one Waldenström’s macroglobulinemia 21 months after initiation, both with intermediate-risk MGUS. TPT was well tolerated with premature discontinuation in 17.2% of cases. Of the two hematologic malignancies identified in the PVDB, only one (MM) occurred in a patient with pre-existing MGUS.

Conclusion

Malignant progression was rare, providing reassuring evidence regarding hematologic safety. TPT may be considered in selected patients with severe osteoporosis and MGUS, provided careful hematologic monitoring.

Graphical abstract

Abstract Image

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用特立帕肽治疗骨质疏松的单克隆伽玛病患者的恶性转化：法国国家药物警戒数据库的一项双中心回顾性研究和分析。

评价特立帕肽治疗意义不明的单克隆伽玛病患者的恶性转化。在29例患者中，只有2例进展为血液恶性肿瘤（1例多发性骨髓瘤，1例Waldenström巨球蛋白血症）。这些发现令人放心，并表明TPT可能仍然是严重骨质疏松症和MGUS患者的选择。目的：骨质疏松症是一种非常普遍的骨病，治疗选择有限，特别是在多病患者中。未确定意义单克隆γ病变（MGUS）是骨质疏松症的常见发现，也是公认的骨折危险因素，通常导致特立帕肽（TPT）的禁忌症，进一步限制了治疗选择。本研究旨在评估骨质疏松性MGUS患者经TPT治疗后的血液学恶性转化。方法：2016-2022年在里尔和昂热大学医院进行回顾性双中心观察研究。纳入了在TPT开始时骨质疏松和确诊MGUS的患者。收集了人口统计学、血液学、骨学和治疗参数。与此同时，法国国家药物警戒数据库（PVDB）同期对TPT报告的血液恶性肿瘤进行了审查。结果：纳入29例患者（69%为女性，平均年龄72.6±12.6岁）。多数患者存在严重合并症（89.7%，Charlson合并症指数≥3）。igg型占55.2%，igm型占41.4%。TPT开始后的平均随访时间为60.2±30.7个月（中位54.0;95% CI 49.0-71.4）。两名患者出现血液恶性肿瘤：一名患者在TPT后7年出现多发性骨髓瘤（MM），一名患者在TPT后21个月出现Waldenström巨球蛋白血症，均为中危MGUS。TPT耐受性良好，17.2%的病例过早停药。在PVDB中发现的两种血液恶性肿瘤中，只有一种（MM）发生在已有MGUS的患者中。结论：恶性进展罕见，为血液安全提供了可靠的证据。在提供仔细的血液学监测的情况下，选择性的严重骨质疏松症和MGUS患者可以考虑TPT。

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来源期刊

Archives of Osteoporosis ENDOCRINOLOGY & METABOLISMORTHOPEDICS -ORTHOPEDICS

CiteScore

5.50

自引率

10.00%

发文量

133

期刊介绍： Archives of Osteoporosis is an international multidisciplinary journal which is a joint initiative of the International Osteoporosis Foundation and the National Osteoporosis Foundation of the USA. The journal will highlight the specificities of different regions around the world concerning epidemiology, reference values for bone density and bone metabolism, as well as clinical aspects of osteoporosis and other bone diseases.