Dataset Information

Risk factors for nonresponse to 2 years of denosumab administration in patients with osteoporosis: A retrospective single-center cohorts study.

ABSTRACT:

Background and aims

To investigate the factors associated with changes in bone mineral density (BMD) and the incidence of fractures in osteoporotic patients treated with denosumab.

Methods

This retrospective study included 162 osteoporotic patients treated with denosumab for 24 months between 2013 and 2019. Patients were divided according to the changes in BMD as nonresponders (N_L group: <3% increase in lumbar spine BMD [LBMD], N_H group: <0% increase in femoral neck BMD [FNBMD]) or responders (R_L group: ≥3% increase in LBMD, R_H group: ≥0% increase in FNBMD).

Results

The respective changes in the LBMD and FNBMD after 24 months of denosumab treatment were 9.3% (95% confidence interval [CI]: 8.1-10.6) and 3.3% (95% CI: 2.1-4.5). Twenty-eight (17.3%) patients were in the N_L group, and 134 (82.7%) were in the R_L group. A history of bisphosphonate treatment was a risk factor for being in the N_L group (odds ratio [OR]: 3.84, 95% CI: 1.38-10.71, p = 0.007; adjusted OR: 3.21, 95% CI: 1.01-10.19, p = 0.048). Although the N_H (n = 48; 30.8%) and R_H (n = 108; 69.2%) groups had similar baseline characteristics, the N_H group had a significantly higher baseline FNBMD than the R_H group (p = 0.003). The change in FNBMD was negatively associated with the FNBMD at baseline (r = -0.34, p < 0.001). No new osteoporotic fractures occurred in either group during follow-up.

Conclusion

In osteoporotic patients receiving denosumab treatment, a history of bisphosphonate treatment was a risk factor for a lack of increase in LBMD, and a higher FNBMD at baseline was negatively associated with the change in FNBMD.

SUBMITTER: Yamamoto A

PROVIDER: S-EPMC10995440 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature

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Publications

Risk factors for nonresponse to 2 years of denosumab administration in patients with osteoporosis: A retrospective single-center cohorts study.

Yamamoto Akiko A Nagao Masashi M Nishizaki Yuji Y Maeda Eri E Ishijima Muneaki M

Health science reports 20240404 4

<h4>Background and aims</h4>To investigate the factors associated with changes in bone mineral density (BMD) and the incidence of fractures in osteoporotic patients treated with denosumab.<h4>Methods</h4>This retrospective study included 162 osteoporotic patients treated with denosumab for 24 months between 2013 and 2019. Patients were divided according to the changes in BMD as nonresponders (N<sub>L</sub> group: <3% increase in lumbar spine BMD [LBMD], N<sub>H</sub> group: <0% increase in femor ...[more]

PMID: 38585014

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Project description:ContextCurrent osteoporosis medications increase bone mineral density (BMD) modestly and reduce, but do not eliminate, fracture risk. Attempts to improve efficacy by administering anabolic agents and bisphosphonates concomitantly have been unsuccessful. Conversely, 12 months of concomitant denosumab and teriparatide therapy increases BMD more than either drug alone.ObjectiveThe purpose of this study was to determine whether 24 months of combined denosumab and teriparatide will increase hip and spine BMD more than either individual agent.DesignPreplanned continuation of the Denosumab and Teriparatide Administration (DATA) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide (20 μg daily), denosumab (60 mg every 6 months), or both medications for 24 months.ParticipantsParticipants were 94 postmenopausal women with osteoporosis.Outcome measuresLumbar spine, femoral neck, total hip, and distal radius BMD and serum markers of bone turnover were measured.ResultsAt 24 months, lumbar spine BMD increased more in the combination group (12.9 ± 5.0%) than in either the teriparatide (9.5 ± 5.9%, P = .01) or denosumab (8.3 ± 3.4%, P = .008) groups. Femoral neck BMD also increased more in the combination group (6.8 ± 3.6%) than in either the teriparatide (2.8 ± 3.9%, P = .003) or denosumab (4.1 ± 3.8%, P = .008) groups. Similarly, total hip BMD increased more in the combination group (6.3 ± 2.6%) than in the teriparatide (2.0 ± 3.0%) or denosumab (3.2 ± 2.5%) groups (P < .001 for both). Although spine and hip BMD continued to increase in the second year in all groups, these year 2 increases did not differ among groups. Serum C-telopeptide and N-terminal propeptide of type 1 procollagen were equally suppressed in the denosumab and combination groups, whereas osteocalcin decreased more in the denosumab group than in the combination group, a difference that persisted, but lessened, in the second year of therapy.ConclusionsTwo years of concomitant teriparatide and denosumab therapy increases BMD more than therapy with either medication alone and more than has been reported with any current therapy. The combination of these agents may prove to be an important treatment option in patients at high risk of fracture.

Project description:Most subjects in osteoporosis clinical trials were women with postmenopausal osteoporosis and while bridging studies (BMD endpoint) provide an expectation that osteoporosis medications will reduce fracture risk in men. This real-world study shows direct evidence of fracture risk reduction among men with osteoporosis (36% of hip fracture reduction with denosumab).PurposeDirect evidence for fracture risk reduction of medications used among men with osteoporosis is very limited. This study aims to evaluate the real-world effectiveness of denosumab in reducing fracture risk.MethodsThis study included 13,797 men aged ≥ 50 years with osteoporosis who had initiated denosumab in Taiwan. Taiwan's National Health Insurance Research Database includes all Taiwan residents' complete health claim data. We compared incidence rates of clinical fractures between patients on denosumab 60 mg subcutaneously every 6 months (on-treatment) and patients ending therapy after one administration (off-treatment). Propensity score (PS) analysis, adjusting for measured differences at baseline covariates, was used to estimate the adjusted hazard ratio using a Cox proportion hazards model.ResultsDuring follow-up, 248 hip fracture events occurred. The crude incidence rates of hip fracture were 1.13 events and 1.73 events per 100 person-years in on-treatment and off-treatment cohorts, respectively. After PS inverse probability of treatment weighting, the cohorts achieved balance in all 59 covariates. The hip fracture event rate was lower in on-treatment cohort versus off-treatment cohort by 36% (hazard ratio, 0.64 [95% CI 0.50-0.83]). A similar magnitude of risk reduction was observed in clinical vertebral and nonvertebral fractures. A series of sensitivity analysis, including a validation analysis using a-million individual health records, demonstrated that unmeasured confounders were not suggested to impact study result interpretation.ConclusionIn this large, real-world study evaluating denosumab treatment among men with osteoporosis, the observed fracture risk reductions were consistent with the available risk reductions demonstrated in clinical trials among women with postmenopausal osteoporosis.

Project description:BackgroundLittle is known on how denosumab reduces skeletal-related events (SREs) by bone metastases from solid tumors. We sought to evaluate the effect of denosumab administration in patients with bone metastases from solid tumors.MethodsData of patients treated with denosumab were collected from electronic medical charts (n = 496). Eligible participants in this study were adult patients (age ≥ 18 years) with metastatic bone lesions from solid tumors treated with denosumab. SREs, surgical interventions, the spinal instability neoplastic score (SINS) for spinal region, and Mirels' score for the appendicular region were evaluated. To assess whether denosumab could prevent SREs and associated surgery, the SINS and Mirels' score were compared between patients with and without SREs.ResultsA total of 247 patients (median age, 65.5 years old; median follow-up period, 13 months) treated with denosumab for metastatic bone lesions from solid tumors were enrolled in this study. SREs occurred in 19 patients (7.7%). SREs occurred in 2 patients (0.8%) who took denosumab administration before SREs. Surgical interventions were undertaken in 14 patients (5.7%) (spinal and intradural lesions in five patients and appendicular lesions in nine patients). The mean SINS of patients without SREs compared to those with SREs were 7.5 points and 10.2 points, respectively. The mean Mirels' scores of non-SREs patients and those with SREs were 8.07 points and 10.7 points, respectively. Patients with SREs had significantly higher Mirels' score than non-SREs patients (p < 0.01). Patients with SREs had higher SINS than non-SREs patients (p = 0.09).ConclusionsSREs occurred in patients with higher SINS or Mirels' scores. Two patients suffered from SREs though they took denosumab administration before SREs. Appropriate management of denosumab for patients with bone metastasis is significant. Surgical interventions may be needed for patients who with higher SINS or Mirel's scores.

Dataset Information

Risk factors for nonresponse to 2 years of denosumab administration in patients with osteoporosis: A retrospective single-center cohorts study.

Background and aims

Methods

Results

Conclusion

Publications

Risk factors for nonresponse to 2 years of denosumab administration in patients with osteoporosis: A retrospective single-center cohorts study.

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