Original Title: Dosage sanguin du propeptide N-terminal du procollagène de type 1 (P1NP) au moyen d’un essai immunologique par électrochimiluminescence (ECLIA)

Authors' objectives: P1NP testing by ECLIA was first evaluated by INESSS in 2015, which led to its refusal for inclusion in the Répertoire. Although the clinical validity and utility of this test were recognized in people treated with teriparatide, additional analytical data from locally tested clinical specimens were needed.

Authors' results and conclusions: RESULTS (#1 POPULATION DIMENSION): • Bone mineral density (BMD) measurement is used to, among other things, evaluate bone response one or two years after the initiation of anti-osteoporosis treatments. • Variations in bone remodeling markers measured after a few months of therapeutic intervention may predict long-term bone response. (#2 CLINICAL DIMENSION - CLINICAL VALIDITY): Data showing that P1NP measurement provides information on fracture risk in the context of anabolic treatment are limited. (#2.1 CLINICAL DIMENSION - CLINICAL UTILITY): According to the literature and the consulted clinicians, measuring P1NP could enable early detection of an inadequate response to treatment, helping to adjust the therapeutic strategy, correct a compliance problem, or identify a secondary cause of osteoporosis. (#3 SOCIOCULTURAL DIMENSION): • Canadian and international guidelines recommend that family physicians do not monitor bone remodeling markers in people with osteoporosis. • In some countries, P1NP testing appears to have already been integrated into osteoporosis care pathways to assess treatment response. (#4 ORGANIZATIONAL DIMENSION): • The two-week turnaround time proposed by the requesting laboratory is considered acceptable by the consulted clinicians. • P1NP blood testing should be limited to medical specialists in osteoporosis and other bone diseases. (#5 ECONOMIC DIMENSION): • The estimated net budget impact of introducing P1NP testing to the Répertoire is approximately $168,000 over the first three years, assuming that access is restricted to specialists in osteoporosis and other bone diseases and the target population includes new patients receiving teriparatide or romosozumab. • The effect of P1NP testing on drug costs and other potential changes in clinical practice is uncertain.

Authors' recommendations: Based on the above findings, the INESSS recommends that the Minister introduce P1NP blood testing using electrochemiluminescence immunoassay (ECLIA) in the Répertoire. However, to mitigate the risk of inappropriate use, INESSS recommends the following measures to ensure proper use of the test:  The test should be restricted to specialists in osteoporosis and other bone diseases who prescribe anabolic agents, monitor complex or rare clinical cases, or monitor and treat symptomatic cases of Paget's disease.  The INESSS proposes to evaluate the current use of osteocalcin testing, as high volume indicates suboptimal use.  The test must meet the requirements of ISO 15189.

Project Status: Completed

Year Published: 2025

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/dosage-sanguin-du-propeptide-n-terminal-du-procollagene-de-type-1-p1np-au-moyen-dun-essai-immunologique-par-electrochimiluminescense-eclia.html

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: L'Institut national d'excellence en sante et en services sociaux (INESSS)