Multiple vertebral fractures after antiosteoporotic medications discontinuation: A comparative study to evaluate the potential rebound effect of denosumab

Article

作者: Elisa, Martín-Merino ; Mar, Martín-Pérez ; Patricia, García-Poza ; Beatriz, Sánchez-Delgado ; López-Álvarez, Sergio

BACKGROUNDDiscontinuation of anti-osteoporotic medications (AOM), except for bisphosphonates (BP), is not favorable for the bone, being especially negative for Prolia® (60 mg denosumab-DMAb). DMAb withdrawal leads to a rapid and significant increase in bone turnover markers (BTMs), and to an important loss in bone mineral density, which has been associated with an increased risk of MVF.OBJECTIVETo assess the risk of multiple vertebral fractures (MVF; ≥2 VF recorded at the same time) after discontinuation of different AOM.METHODSA case-control analysis nested in a cohort of new users of DMAb, BP, Teriparatide (TPTD), Strontium Ranelate (SrRan), or selective estrogen receptor modulators (SERM), aged ≥18 years from 2011 to 2018 with ≥1 year of prior available data, was performed using the Pharmacoepidemiological Research Database for the Public Health System (BIFAP) in Spain. Cases were first MVF recorded after AOM initiation (index date). Up to 4 controls per case, matched on index date, age, sex, and location, were randomly selected among non-cases from the cohort. Adjusted conditional OR (AOR) and 95 % CI: between discontinuation of a given AOM (supply of the last prescription ended >90 days before the index date) and occurrence of MVF was assessed compared with their current use and alternatively, with discontinuation of BP, among individuals who did not switch therapy in the study.RESULTSA total of 532 incident cases of MVF were identified and matched to 2121 controls (86 % women; median age 73 years). AOR of MVF after DMAb discontinuation was 2.82 (1.73-4.60) compared with DMAb current use. No risk was seen for the other AOM. The AOR was highest between 3 and 9 months after discontinuation of denosumab (8.58; 3.98-18.48) and after >1 year of cumulative use (5- and 11-times increased risk when discontinuing after 1-2 years and 2-5 years of use, respectively). Compared with BP discontinuers, discontinuation of DMAb (2.73, 1.66-4.50), TPTD (2.06, 1.09-3.88) and SrRan (1.93, 1.23-3.05) showed an increased risk of MVF; current use of DMAb showed no protective effect (1.44; 0.95-2.17).CONCLUSIONSDiscontinuation of DMAb was associated with an immediate increased risk of MVF, especially after longest treatments compared with patients who continued therapy or discontinued BP. Although there were increased risks after discontinuation of other AOM in comparison with first- line therapy (BP), these were not found when the reference was current users. Confounding by indication cannot be discarded. Larger studies should investigate reasons for discontinuation and preventive retreatment options.

CLINICAL CASES IN MINERAL AND BONE METABOLISM

Evaluation of persistence and adherence to teriparatide treatment in patients affected by severe osteoporosis (PATT): a multicenter observational real life study

Article

作者: Iolascon G ; Migliaccio S ; Mulè R ; Celi M ; Di Pietro G ; Fornari R ; Lenzi A ; Dormi A ; Tarantino U ; Gimigliano F ; Resmini G ; Frigato M ; Malavolta N ; Buffa A ; Cerocchi I

INTRODUCTIONOsteoporosis is a chronic condition leading to an increased risk of developing fractures, with high morbidity and mortality in aging population. Efficacy of anti-osteoporotic treatment is based on drug potency but also on compliance and persistence to treatment regimen, which is very low, as already described for other diseases. Teriparatide (TPTD) is the first anabolic agent developed for the treatment of osteoporosis. Since it appears that persistence to Teriparatide declines over time, aim of this pilot multicenter observational study was to evaluate persistence and adherence to TPTD (20 μg daily injection regimen for 18 months) treatment (PATT) in patients affected by severe osteoporosis in an every day clinical practice.METHODSPatients affected by severe osteoporosis were selected among those who referred to 5 different specialized centers for osteoporosis in North, Center and South of Italy. A sample of 475 women with severe postmenopausal osteoporosis treated with TPTD in accordance to the Italian osteoporosis guidelines was included. At the beginning of TPTD treatment patients were instructed on the use of the device by the referring specialist of the center, a resident fellow or a nurse. Bone biochemical markers were evaluated the same morning and after 1, 3, 6, 12 and 18 months. Patients were visited at time 0 and after 6, 12 and 18 months for clinical follow up.RESULTSThe results included observations of 441/475 patients (98% women) who completed the 18 months treatment; mean age for women was 73±8 and for men 65±9. After 6 months of TPTD treatment persistence was of 89,79%, 87,75% after 12 months and 86,85% after 18 months. Adherence was of 100% at 6,12 and 18 months. Total dropouts were 13,15% (71/441), which was usually higher within the first 6 months of TPTD treatment. Most common adverse events (arthralgies 2,7%, dizziness 1,8%, migraine 1,8%, depression 1,6%, hypertension 1,1%) were reported in 62/441 patients (14%) of patients, but were not reason for stopping treatment.CONCLUSIONSThe persistence and adherence to TPTD treatment obtained in this multicenter observational real life study was very high as compared to studies performed by others. These encouraging results suggest that different key factors such quality of information, frequency of visits, motivations given to patients, opportunity to call the doctor might play a pivotal role in the high persistence and adherence to TPTD treatment obtained in our study and need to be carefully considered before prescribing chronic anti-osteoporotic therapy.

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