Effectiveness of anti-osteoporotic treatment after successful parathyroidectomy for primary hyperparathyroidism: a randomized, double-blind, placebo-controlled trial.
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SUBMITTER: Niederle MB
PROVIDER: S-EPMC6906217 | biostudies-literature | 2019 Sep
REPOSITORIES: biostudies-literature
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Effectiveness of anti-osteoporotic treatment after successful parathyroidectomy for primary hyperparathyroidism: a randomized, double-blind, placebo-controlled trial.
Niederle Martin B MB Foeger-Samwald Ursula U Riss Philipp P Selberherr Andreas A Scheuba Christian C Pietschmann Peter P Niederle Bruno B Kerschan-Schindl Katharina K
Langenbeck's archives of surgery 20190826 6
<h4>Purpose</h4>After successful surgery for primary hyperparathyroidism, bone mineral density (BMD) does not improve equally in all patients. As no trial has so far aimed to influence normalization of BMD, it was the goal of this investigation to determine whether pharmacological treatment is effective in improving regain of BMD after successful parathyroidectomy in patients with preoperatively diagnosed osteoporosis or osteopenia and to evaluate when treatment may be indicated.<h4>Methods</h4> ...[more]
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| S-EPMC9995748 | biostudies-literature
Project description:Vitamin D insufficiency may increase the risk for cardio metabolic disturbances in patients with primary hyperparathyroidism (PHPT).To analyze the vitamin D status and indices of the metabolic syndrome in PHPT patients and the effect of vitamin D supplementation after parathyroid adenomectomy (PTX).Double-blinded, randomized clinical trial (ClinicalTrials.gov identifier: NCT00982722) performed at Karolinska University Hospital, Sweden, April 2008 to November 2011. One hundred and fifty consecutive patients with PHPT (119 women) were randomized after PTX, 75 to oral treatment with calcium carbonate 1000?mg daily and 75 to calcium carbonate 1000?mg and cholecalciferol 1600?IU daily over 12 months. Changes in metabolic profile and ambulatory blood pressure (BP) were analyzed. Main outcome measures were changes in metabolic factors, BP, and body composition.The 25-hydroxyvitamin D (25-OH-D)-level was <50?nmol/l in 76% of the patients before PTX. After PTX, glucose, insulin, and IGF1 decreased, while the 25-OH-D and the IGF-binding protein 1 increased and remained unchanged at follow-up after study medication. One year of vitamin D supplementation resulted in lower parathyroid hormone (PTH) (40 (34-52) vs 49 (38-66) ng/l) and higher 25-OH-D (76 (65-93) vs 49 (40-62) nmol/l; P<0.05). Other laboratory parameters were stable compared with after PTX. Systolic BP decreased and total bone mineral content increased in both groups.Except for the lowering of the PTH level, no additive effect of vitamin D supplementation was seen. However, PTX proved effective in reducing insulin resistance.
| S-EPMC3805017 | biostudies-literature
Project description:ImportanceHyperparathyroidism is associated with cardiovascular disease. However, evidence for a beneficial consequence of parathyroidectomy on hypertension is limited.ObjectiveTo investigate if parathyroidectomy improves hypertension in patients with primary hyperparathyroidism (PHPT).Design, setting, and participantsIn this cohort study and retrospective database review, patients with PHPT and hypertension between January 1, 2008, and December 31, 2016, were identified. The mean arterial pressure (MAP) and number of antihypertensive medications were compared between those who did and did not undergo parathyroidectomy. The setting was a large health care system. Primary hyperparathyroidism was defined using biochemical data, and hypertension was identified by International Classification of Diseases, Ninth Revision codes.ExposureParathyroidectomy was identified in the database by Current Procedural Terminology codes.Main outcomes and measuresThe MAP and use of antihypertensive medications were compared for patients who underwent parathyroidectomy and those who did not at 6 months, 1 year, and 2 years. Multivariable logistic regression was used to assess the adjusted odds ratios for both increased and decreased use of antihypertensive medications.ResultsIn this cohort study of 2380 participants (79.0% female), patients undergoing parathyroidectomy (n = 501) were younger (mean [SD] age, 65.3 [9.7] vs 71.9 [10.4] years; P < .001) and took fewer antihypertensive medications at baseline (mean [SD] number of medications, 1.2 [1.1] vs 1.5 [1.3], P < .001) than nonsurgical patients (n = 1879). Patients with parathyroidectomy showed greater improvement in their MAP at all follow-up time points (the median [SD] MAP change from baseline to 1 year was 0.1 [8.7] mm Hg without parathyroidectomy vs -1.2 [7.7] mm Hg after parathyroidectomy, P = .002). Nonsurgical patients were more likely vs those with parathyroidectomy to require more antihypertensive medications at 6 months (15.9% [n = 298] vs 9.8% [n = 49], P = .001), 1 year (18.1% [n = 340] vs 10.8% [n = 54], P < .001), and 2 years (17.6% [n = 330] vs 12.2% [n = 61], P = .004). By multivariable analysis, parathyroidectomy was independently associated with freedom from an increased number of antihypertensive medications at all periods (eg, adjusted odds ratio, 0.49; 95% CI, 0.34-0.70; P < .001 at 1 year). Among patients who were initially not taking antihypertensive medications, patients with parathyroidectomy were less likely vs no surgery to start antihypertensive medication treatment at all periods (eg, 10.2% [13 of 127] vs 30.4% [136 of 447], P < .001 at 1 year).Conclusions and relevanceThis study's findings suggest that, among hypertensive patients with PHPT, parathyroidectomy may be associated not only with greater decreases in their MAP but also with reduced requirements for antihypertensive medications. Parathyroidectomy decreased the number of patients who began taking antihypertensive medications. Additional study will be required to find whether there are downstream cardiovascular benefits of parathyroidectomy. Preexisting hypertension, particularly in those not already taking antihypertensive medications, should be considered when weighing surgical treatment.
| S-EPMC6802266 | biostudies-literature
Project description:UNLABELLED: BACKGROUND: Increasing evidence suggests the bidirectional interplay between parathyroid hormone and aldosterone as an important mechanism behind the increased risk of cardiovascular damage and bone disease observed in primary hyperparathyroidism. Our primary object is to assess the efficacy of the mineralocorticoid receptor-blocker eplerenone to reduce parathyroid hormone secretion in patients with parathyroid hormone excess. METHODS/DESIGN: Overall, 110 adult male and female patients with primary hyperparathyroidism will be randomly assigned to eplerenone (25 mg once daily for 4 weeks and 4 weeks with 50 mg once daily after dose titration] or placebo, over eight weeks. Each participant will undergo detailed clinical assessment, including anthropometric evaluation, 24-h ambulatory arterial blood pressure monitoring, echocardiography, kidney function and detailed laboratory determination of biomarkers of bone metabolism and cardiovascular disease.The study comprises the following exploratory endpoints: mean change from baseline to week eight in (1) parathyroid hormone(1-84) as the primary endpoint and (2) 24-h systolic and diastolic ambulatory blood pressure levels, NT-pro-BNP, biomarkers of bone metabolism, 24-h urinary protein/albumin excretion and echocardiographic parameters reflecting systolic and diastolic function as well as cardiac dimensions, as secondary endpoints. DISCUSSION: In view of the reciprocal interaction between aldosterone and parathyroid hormone and the potentially ensuing target organ damage, the EPATH trial is designed to determine whether eplerenone, compared to placebo, will effectively impact on parathyroid hormone secretion and improve cardiovascular, renal and bone health in patients with primary hyperparathyroidism. TRIAL REGISTRATION: ISRCTN33941607.
| S-EPMC3515510 | biostudies-literature
Project description:BACKGROUND:Studies have shown that the response of bone mineral density (BMD) to parathyroidectomy for symptomatic primary hyperparathyroidism (PHPT) is heterogeneous and difficult to predict. However, the independent factors affecting BMD in PHPT patients after parathyroidectomy remains limited and inconclusive. This study aimed to explore the independent factors affecting BMD changes in symptomatic PHPT patients after parathyroidectomy. METHODS:This study retrospectively analyzed 105 patients with symptomatic PHPT treated at Beijing Jishuitan Hospital between January 2010 and December 2015. The primary outcome was a?>?10% increase in BMD at 3?years after parathyroidectomy compared with the preoperative value, whereas the secondary outcomes were BMD changes at various measurement sites. RESULTS:A total of 105 patients with a mean age of 46.37?years were included in this study. Univariate logistic regression analysis indicated that hypertension (odds ratio [OR[: 0.032; 95% confidence interval [CI]: 0.001-0.475; P?=?0.012), and parathyroid hormone level (OR: 1.006; 95% CI: 1.004-1.009; P?=?0.044) were associated with the >?10% BMD increase. However, these results were not significant after adjustments for potential confounders. Moreover, the BMD values at the lumbar spine, femoral neck, femoral trochanter, Ward's triangle, and whole body after parathyroidectomy were significantly greater than those before the operation (P?<?0.05). CONCLUSIONS:This study suggests that patient characteristics were not associated with the >?10% BMD increase. However, the BMD values of the femur and lumbar spine were significantly increased in symptomatic PHPT patients after parathyroidectomy.
| S-EPMC7490883 | biostudies-literature
Project description:BackgroundIn kidney transplant patients, parathyroidectomy is associated with an acute decrease in renal function. Acute and chronic effects of parathyroidectomy on renal function have not been extensively studied in primary hyperparathyroidism (PHPT).MethodsThis retrospective cohort study included 494 patients undergoing parathyroidectomy for PHPT. Acute renal changes were evaluated daily until day 4 post-parathyroidectomy and were stratified according to acute kidney injury (AKI) criteria. Biochemical assessment included serum creatinine, total and ionized calcium, parathyroid hormone (PTH), and 25-hydroxyvitamin D (25OHD). The estimated glomerular filtration rate (eGFR) was calculated using the CKD-EPI equation. We compared preoperative and postoperative renal function up to 5 years of follow-up.ResultsA total of 391 (79.1%) patients were female, and 422 (85.4%) were non-African American. The median age was 58 years old. The median (first and third quartiles) preoperative serum creatinine, PTH and total calcium levels were 0.81 mg/dL (0.68-1.01), 154.5 pg/mL (106-238.5), and 10.9 mg/dL (10.3-11.5), respectively. The median (first and third quartiles) preoperative eGFR was 86 mL/min/1.73 m2 (65-101.3). After surgery, the median acute decrease in the eGFR was 21 mL/min/1.73 m2 (p<0.0001). Acutely, 41.1% of patients developed stage 1 AKI, 5.9% developed stage 2 AKI, and 1.8% developed stage 3 AKI. The acute eGFR decrease (%) was correlated with age and PTH, calcium and preoperative creatinine levels in univariate analysis. Multivariate analysis showed that the acute change was related to age and preoperative values of ionized calcium, phosphorus and creatinine. The change at 12 months was related to sex, preoperative creatinine and 25OHD. Permanent reduction in the eGFR occurred in 60.7% of patients after an acute episode.ConclusionThere was significant acute impairment in renal function after parathyroidectomy for PHPT, and almost half of the patients met the criteria for AKI. Significant eGFR recovery was observed during the first month after surgery, but a small permanent reduction may occur. Patients treated for PHPT seemed to present with prominent renal dysfunction compared to patients who underwent thyroidectomy.
| S-EPMC7774859 | biostudies-literature
Project description:ImportanceParathyroidectomy provides definitive management for primary hyperparathyroidism (PHPT), reducing the risk of subsequent fracture, nephrolithiasis, and chronic kidney disease (CKD), but its use among older adults in the US is unknown.ObjectiveTo identify patient characteristics associated with the use of parathyroidectomy for the management of PHPT in older adults.Design, setting, and participantsThis population-based, retrospective cohort study used 100% Medicare claims from beneficiaries with an initial diagnosis of PHPT from January 1, 2006, to December 31, 2016. Patients were considered to meet consensus guideline criteria for parathyroidectomy based on diagnosis codes indicating osteoporosis, nephrolithiasis, or stage 3 CKD. Multivariable logistic regression was used to identify patient characteristics associated with parathyroidectomy. Data were analyzed from February 11, 2020, to October 8, 2020.Main outcomes and measuresThe primary outcome was parathyroidectomy within 1 year of diagnosis.ResultsAmong 210 206 beneficiaries with an incident diagnosis of PHPT (78.8% women; mean [SD] age, 75.3 [6.8] years), 63 136 (30.0%) underwent parathyroidectomy within 1 year of diagnosis. Among the subset of patients who met consensus guideline criteria for operative management (n = 131 723), 38 983 (29.6%) were treated with parathyroidectomy. Patients treated operatively were younger (mean [SD] age, 73.5 [5.7] vs 76.0 [7.1] years) and more likely to be White (90.1% vs 86.0%), to be robust or prefrail (92.1% vs 85.7%), and to have fewer comorbidities (Charlson Comorbidity Index score of 0 or 1, 54.6% vs 44.1%), in addition to being more likely to live in socioeconomically disadvantaged (46.9% vs 40.3%) and rural (18.1% vs 13.6%) areas (all P < .001). On multivariable analysis, increasing age had a strong inverse association with parathyroidectomy among patients aged 76 to 85 years (unadjusted rate, 25.9%; odds ratio [OR], 0.68 [95% CI, 0.67-0.70]) and older than 85 years (unadjusted rate, 11.2%; OR, 0.27 [95% CI, 0.26-0.29]) compared with those aged 66 to 75 years (unadjusted rate, 35.6%), as did patients with moderate to severe frailty (unadjusted rate, 18.9%; OR, 0.60 [95% CI, 0.56-0.64]) compared with robust patients (unadjusted rate, 36.1%) and those with a Charlson Comorbidity Index score of 2 or greater (unadjusted rate, 25.9%; OR, 0.77 [95% CI, 0.75-0.79]) compared with a Charlson Comorbidity Index score of 0 (unadjusted rate, 37.0%). With regard to operative guidelines, a history of nephrolithiasis increased the odds of parathyroidectomy (OR, 1.43 [95% CI, 1.39-1.47]); stage 3 CKD decreased the odds of parathyroidectomy (OR, 0.71 [95% CI, 0.68-0.74]); and osteoporosis showed no association (OR, 1.01 [95% CI, 0.99-1.03]).Conclusions and relevanceIn this cohort study, most older adults with PHPT did not receive definitive treatment with parathyroidectomy. Older age, frailty, and multimorbidity were associated with nonoperative management, and guideline recommendations had minimal effect on treatment decisions. Further research is needed to identify barriers to surgical care and develop tools to target parathyroidectomy to older adults most likely to benefit.
| S-EPMC7788507 | biostudies-literature
Project description:BackgroundPrimary hyperparathyroidism is a prevalent endocrinopathy for which surgery is the only curative option. Parathyroidectomy is primarily recommended in younger and symptomatic patients, while there are still concerns regarding surgical complications in older patients. We therefore assessed the association of age with surgical outcomes in patients undergoing parathyroidectomy in a large population in Switzerland.MethodsPopulation-based cohort study of adult patients with primary hyperparathyroidism undergoing parathyroidectomy in Switzerland between 2012 and 2018. The cohort was divided into four age groups (<50 years, 50-64 years, 65-74 years, ≥75 years). The primary outcome was a composite of in-hospital postoperative complications. Secondary outcomes were intensive care unit (ICU) admission, unplanned 30-day-readmission, and prolonged length of hospital stay.ResultsWe studied 2642 patients with a median (IQR) age of 62 (53-71) years. Overall, 111 patients had complications including surgical re-intervention, hypocalcemia, and vocal cord paresis. As compared to <50 year-old patients, older patients had no increased risk for in-hospital complications after surgery (50-64 years: odds ratio (OR): 0.51 (95% CI, 0.28 to 0.92); 65-74 years: OR: 0.72 (95% CI, 0.39 to 1.33); ≥75 years: OR: 1.03 (95% CI, 0.54 to 1.95), respectively. There was also no association of age and rates of ICU-admission and unplanned 30-day-readmission, but oldest patients had longer hospital stays (OR: 2.38 (95% CI, 1.57 to 3.60)).Conclusion≥50 year-old patients undergoing parathyroidectomy had comparable risk of in-hospital complications as compared with younger ones. These data support parathyroidectomy in even older patients with primary hyperparathyroidism as performed in clinical routine.
| S-EPMC8558907 | biostudies-literature
Project description:ObjectiveSeveral studies indicate that patients with primary hyperparathyroidism (PHPT) undergoing parathyroid surgery have improvement in mood and neuropsychological functioning. The current analysis aims to examine the relationship between biochemical and clinical variables and the improvement in depression scores and in specific symptoms, after parathyroidectomy.DesignA prospective observational case-control study at a referral centre.PatientsPatients with PHPT undergoing parathyroidectomy (n = 88) or thyroid surgery (n = 85).MeasurementsThe Patient Health Questionnaire-9 (PHQ-9) was utilized to obtain depression scores at enrolment and 12 months after surgery. The changes in PHQ-9 were analysed and correlated with baseline clinical and biochemical parameters.ResultsAt enrolment, there was no difference between the groups in the number with a depression diagnosis (PHPT 34.1%, thyroid surgery, 35.5%, P = 0.86). However, baseline PHQ-9 scores were significantly higher in PHPT (median 7.5, range 0-27) than thyroid surgery patients (median 3.0, range 0-18, P < 0.0001). Following surgery, all PHQ-9 scores, total and symptom group (cognitive, somatic) improved and were no longer different between PHPT (total PHQ-9 median 2, range 0-16) and thyroid (median 1, range 0-14, P = 0.31) groups. Baseline parathyroid hormone level, but not calcium, had a weak relationship with change in PHQ-9 score after parathyroid surgery (P = 0.003). Baseline PHQ-9 score was correlated with change in PHQ-9 score at 12 months after parathyroid surgery (P < 0.001).ConclusionsDepression scores improve in both somatic and cognitive domains after parathyroidectomy for PHPT and baseline severity of depression predicts the response.
| S-EPMC9362855 | biostudies-literature
Project description:Parathyroidectomy is the only curative therapy for patients with primary hyperparathyroidism. However, the incidence, correlates and consequences of parathyroidectomy for primary hyperparathyroidism across the entire US population are unknown. We evaluated temporal trends in rates of inpatient parathyroidectomy for primary hyperparathyroidism, and associated in-hospital mortality, length of stay, and costs. We used the Healthcare Cost and Utilization Project Nationwide Inpatient Sample (NIS) from 2002-2011. Parathyroidectomies for primary hyperparathyroidism were identified using International Classification of Diseases, Ninth Revision codes. Unadjusted and age- and sex- adjusted rates of inpatient parathyroidectomy for primary hyperparathyroidism were derived from the NIS and the annual US Census. We estimated 109,583 parathyroidectomies for primary hyperparathyroidism between 2002 and 2011. More than half (55.4%) of patients were younger than age 65, and more than three-quarters (76.8%) were female. The overall rate of inpatient parathyroidectomy was 32.3 cases per million person-years. The adjusted rate decreased from 2004 (48.3 cases/million person-years) to 2007 (31.7 cases/million person-years) and was sustained thereafter. Although inpatient parathyroidectomy rates declined over time across all geographic regions, a steeper decline was observed in the South compared to other regions. Overall in-hospital mortality rates were 0.08%: 0.02% in patients younger than 65 years and 0.14% in patients 65 years and older. Inpatient parathyroidectomy rates for primary hyperparathyroidism have declined in recent years.
| S-EPMC4986953 | biostudies-literature