Björnsdóttir, Sigríður

Abstract Disclosure: D.S. Ali: None. Z. Chung: None. L. Kamel: None. S. Björnsdottir: Shire. B.L. Clarke: Shire, Takeda, Ascendis, Calcilytix. S. Hahner: None. L.C. Hofbauer: Amgen Inc, Ascendis, UCB, Ascendis, Amolyte. P. Houillier: None. S.W. Ing: Amgen Inc, Radius Health, Inc, Takeda, AscendAlexion, Amolyt, Ascendis, Calcilytix, Kyowa Kirin. M.A. Levine: Takeda, Amolyt, Calcilytix. M. Mannstadt: Takeda, Amolyt, Calcilytix. L. Rejnmark: Takeda, Amolyt, Ascendis, Calcilytix. D.M. Shoback: Amolyt, Ascendis, member of the advisory board (PARADIGHM). M. Brandi: Takeda, Eli Lilly & Company, Calcilytix, Kyowa Kirin, UCB, Abiogen, Alexion, Amolyt, Amorphical, Bruno Farmaceutici, CoGeDi, Echolight. A.A. Khan: Takeda, Amgen Inc, Alexion, Ascendis, Amolyt, Calcilytix. Background: Hypoparathyroidism (HypoPT) is a rare endocrine disorder that requires close evaluation and follow up during pregnancy to minimize maternal and fetal complications. The primary objectives of this study are to evaluate the use of rhPTH (1-84) during pregnancy by analyzing data from the PARADIGHM disease registry, and to compare maternal and neonatal outcomes among patients who continued PTH therapy during pregnancy versus those on conventional therapy (CT). Methods: We performed a retrospective analysis of data in the PARADIGHM registry. Maternal and neonatal outcomes in women treated with rhPTH (1-84) were compared to women who received CT. Results: We analyzed 39 pregnancies of 32 women. Of those, 4 women (6 pregnancies) used rhPTH (1-84) either before or during pregnancy and 28 women (33 pregnancies) continued CT during pregnancy. The mean (SD) maternal age at enrollment was 31.7 (5.6) years. Postsurgical HypoPT was the most common etiology (68.8%). The mean gestational age at delivery was 36 (2.4) weeks (PTH-treated) vs 38.3 (3.3) weeks (CT) (p=0.162). Preterm delivery rates were higher in the PTH-treated group (50% vs. 27%, p=0.591), but this was not statistically significant. Two women had pre-eclampsia, one in each group (PTH-treated and CT). In the PTH-treated group, one pregnancy resulted in a stillbirth, and one infant was born with congenital anomalies (16.7% each). Conclusions: The safety of rhPTH (1-84) use in pregnancy cannot be determined at this time. The PTH-treated group exhibited trends towards higher rates of preterm delivery, but the rates of stillbirth, and congenital anomalies were low and comparable in both groups of women. Larger studies are necessary to determine the optimal approach to manage women with HypoPT during pregnancy. Presentation: Sunday, July 13, 2025

Abstract Context Data on cardiovascular outcomes in patients with chronic hypoparathyroidism (hypoPT) are limited. Objective To investigate the risk of cardiovascular outcomes, acute myocardial infarction, atrial fibrillation/flutter, heart failure, valvular heart disease, peripheral artery disease, and stroke/transient ischemic attack (TIA) in patients with chronic hypoPT. Design The Swedish National Patient Registry, the Swedish Prescribed Drug Registry, and the Total Population Registry, 1997-2018. Settings Population-based cohort study in Sweden. Patients National registries were used to identify patients with chronic hypoPT and matched controls. Results A total of 1982 with chronic hypoPT and 19 499 controls were included. After adjustment for cardiovascular risk factors, patients with chronic hypoPT had higher risk of valvular heart disease [hazard ratio (HR) 2.08; 95% confidence interval (CI) 1.67-2.60], peripheral artery disease (HR 1.78; 95% CI 1.41-2.26), heart failure (HR 1.66; 95% CI 1.44-1.90), atrial fibrillation/flutter (HR 1.58; 95% CI 1.38-1.81), acute myocardial infarction (HR 1.31; 95% CI 1.05-1.64), and fatal cardiovascular disease (HR 1.59; 95% CI 1.40-1.80) compared to matched controls. No significant difference in risk of stroke/TIA was observed. Cardiovascular outcomes did not differ between patients with surgical and nonsurgical chronic hypoPT. Females with hypoPT had a significantly increased risk of valvular heart disease, peripheral artery disease, heart failure, atrial fibrillation, myocardial infarction, and fatal cardiovascular disease compared to female controls. There were no differences in any cardiovascular outcomes between males with hypoPT and male controls. Conclusion The risk of cardiovascular diseases was increased in patients with chronic hypoPT, particularly among women. These findings highlight the need for close monitoring and preventive management of cardiovascular risk factors, especially in women.

Abstract Disclosure: S. Bjornsdottir: None. W. Kamal: None. B.L. Langdahl: None. T. Spelman: None. B.L. Clarke: None. O. Kampe: None. Context: Previous studies have shown that patients with hypoparathyroidism (hypoPT) have reduced bone remodeling, with consequent increases in bone density, and abnormalities in microarchitecture and bone strength. It is still not clear whether there is an increased risk of fractures in patients with hypoPT. Objective: The aim of this study was to evaluate the risk of fractures in patients with hypoPT in Sweden. Patients: The Swedish National Patient Register, the Swedish Prescribed Drug Register and the Total Population Register were used to identify 1982 patients with chronic hypoPT (duration ≥ 12 months), and 19820 controls matched by age, sex and county of residency between 1997-2018. The 10th revision of the International Classification of Diseases (ICD) was used to identify fractures. Results: Patients with hypoPT did not have higher risk of any fracture compared to controls (HR 0.96; 95% CI 0.86-1.08). However, patients with hypoPT had a slightly higher risk of vertebral fractures (HR 1.33; 95% CI 1.01-1.75), p= 0.047 and a lower risk of femoral fractures (HR 0.60; 95% CI 0.45-0.82), p= 0.001. There was no significant difference in the risk of fractures of the forearm, p= 0.177, proximal humerus, p= 0.096 or pelvis, p= 0.446. There was no difference in the risk of any fracture between females and males with hypoPT (p for interaction= 0.511). Patients with surgical hypoPT had a significantly higher risk of any fracture compared with patients with non-surgical hypoPT (p for interaction= 0.006). Conclusion: The risk of any fracture was not increased in patients with hypoPT. However, the risk of vertebral fracture was increased, and the risk of femoral fracture was lower than for matched controls. No difference was found in fracture risk between females and males. Patients with surgical hypoPT had a higher fracture risk compared to patients with non-surgical hypoPT. Presentation: Saturday, June 17, 2023

ABSTRACT Chronic hypoparathyroidism is characterized by low serum calcium, increased serum phosphorus, and inappropriately low or decreased serum parathyroid hormone. This rare disorder is associated with a variety of complications. The prevalence, incidence, mortality, financial burden, and epidemiology of complications of this disorder are not well understood. This narrative review summarizes current information on the epidemiology and complications of chronic hypoparathyroidism. The reported prevalence of chronic hypoparathyroidism ranges from 6.4–37/100,000, and the incidence is reported to be 0.8–2.3/100,000/year. Mortality is not increased in studies from Denmark or South Korea but was increased in studies from Scotland and Sweden. The financial burden of this disorder is substantial because of increased health care resource utilization in two studies but not well quantitated. Recognized complications include hypercalciuria, nephrocalcinosis, kidney stones, and chronic kidney disease; low bone turnover and possibly upper extremity fractures; cardiac and vascular calcifications; basal ganglia calcifications, cataracts, infections, neuropsychiatric complications, and difficulties with pregnancy. This review concludes that chronic hypoparathyroidism is a rare disorder associated with significant morbidity that may not increase overall mortality but is associated with a substantial financial burden. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Abstract Context There are scarce data on the management of chronic hypoparathyroidism (hypoPT) in pregnant women. Objective The aim of this study was to evaluate pregnancy outcome and total number of births in maternal chronic hypoPT. Methods The Swedish National Patient Register, The Swedish Prescribed Drug Register, Swedish Medical Birth Register, and the Total Population Register were used to identify 97 women with chronic hypoPT and 1030 age-matched controls who delivered 139 and 1577 singleton infants, respectively, following diagnosis between 1997 and 2017. Results Women in the chronic hypoPT group had more frequent diabetes (DM) and chronic kidney disease (CKD) compared with the control group (P = 0.043 and P < 0.001, respectively). After adjusting for DM, CKD, maternal age at delivery, and calendar year of delivery, chronic hypoPT cases were associated with increased risk of induction of labor (OR, 1.82; 95% CI, 1.13-2.94) and birth of infants with lower birth weight (β-coefficient −188 g; 95% CI, −312.2 to −63.8) compared with controls. No difference was found in infant length, small for gestational age, or head circumference after adjustments. Mean gestational age at delivery after controlling for DM, CKD, and pre-eclampsia was not significantly younger (P = 0.119). There was no difference in congenital malformations or perinatal death and no difference in the total number of infants born between groups (P = 0.518). Conclusion The majority of women with chronic hypoPT had normal pregnancy outcomes, and the overall risks appear low. Maternal chronic hypoPT is, however, associated with higher risk of induction of labor and slightly lower infant birth weight.

Abstract PARADIGHM is an actively recruiting, prospective, observational registry (NCT01922440/EUPAS16927). The primary objective is to evaluate the safety and effectiveness of recombinant human parathyroid hormone, rhPTH(1-84), treatment in patients with chronic hypoparathyroidism (HypoPT) under routine clinical care. The secondary objective is to characterize the clinical course of chronic HypoPT under conditions of routine clinical practice. At enrollment, registry inclusion criteria are patients having a HypoPT diagnosis >6 months and receiving conventional therapy (CT; eg, calcium supplements and active vitamin D), rhPTH(1-84) plus CT, or rhPTH(1-84). We present baseline characteristics of patients as of a June 30 2019 data cut. Baseline was defined as the value entered at the time of enrollment (Visit 1). Baseline symptom data exclude patients who initiated rhPTH(1-84) prior to enrollment (n=68) and are herein presented as two groups: those subsequently prescribed with rhPTH(1-84) after enrollment or those treated with CT. All data are summarized descriptively. Patient data from 64 centers in Europe and North America were analyzed. In the analysis population (n=737), 587 patients (79.6%) were female, 620 (84.1%) were white, and the mean (SD) age was 49.1 (16.45) years. The mean (SD) BMI was 19.3 (5.73) kg/m2 and 30.0 (7.72) kg/m2 in patients aged <18 (n=25) and ≥18 (n=587) years, respectively. The primary cause of HypoPT was thyroid surgery (n=547 [74.2%]; of these, 281 [60.0%] underwent surgery for thyroid cancer). Endocrinologists were the prescribing specialists for most patients (n=660 [89.6%]). Vitamin D and analogs were prescribed for 90.1% of patients (calcitriol, 74.2%, native vitamin D, 47.4%, alfacalcidol, 7.9%,), calcium for 81.0% (calcium carbonate, 57.9%, calcium citrate, 27.1%), and thyroid hormones for 71.2% (levothyroxine, 73.4%; liothyronine, 5.8%). Symptoms reported at enrollment for the rhPTH(1-84) (n=66) and the CT groups (n=603), respectively, included fatigue (53.0%, 39.3%), paresthesia (48.5%, 29.2%), muscle twitching (48.5%, 21.1%), muscle cramping (40.9%, 33.0%), headaches (33.3%, 17.6%), anxiety (28.8%, 20.1%), muscle pain (28.8%, 19.2%), tetany (28.8%, 12.1%), and brain fog (27.3%, 16.3%). The baseline data for the overall population appear to be representative of patients with chronic HypoPT. Baseline data suggest that at enrollment patients prescribed rhPTH(1-84) after enrollment appear to have an increased burden of disease than patients receiving CT based on symptoms. PARADIGHM will be a valuable resource of real-world longitudinal data for patients with chronic HypoPT.

Abstract Context: The majority of patients with hypoparathyroidism (HypoPT) are women. It is not known whether the presence of hypoparathyroidism influences the pregnancy outcomes. Sweden has excellent conditions for research in this area, with high-quality population-based registers covering essentially all inpatient care and birth records. In this study, data were linked from the Swedish National Patient Register and Swedish Medical Birth Register to examine the potential influence of maternal hypoPT on the number of childbirths and various pregnancy outcomes. Design and Setting: Population-based cohort study in Sweden. Patients: Through the Swedish National Patient Register and the Total Population Register, we identified 1267 women with HypoPT and 12 670 age-matched controls who gave birth between 1997 and 2016. Results: There was no significant difference in mean age at delivery for women with HypoPT (32 (SD, 5.2)) years and controls (32.5 (5.0)). There were significantly more women with HypoPT who smoked at baseline (p= 0.007) and within 3 months of pregnancy (p=0.022) compared to controls. Significantly more women with HypoPT had part time work or were not working during pregnancy compared to controls (p = 0.002). The mean number of infants per woman was 0.30 (SD, 0.62) in the HypoPT group and 0.33 (SD, 0.60) in the control group (p=0.644). Compared with the control group, the risk of elective cesarean section was higher in the HypoPT group (p=0.002). However, there was no difference in the proportion of women undergoing an acute cesarean section between cases and controls (p=0.754). The mean pregnancy duration in women with HypoPT was 38.87 (2.11) weeks compared to 39.23 (2.04) weeks for the controls (p= 0.001). Infants born to mothers with HypoPT were significantly shorter (p=0.016), but no difference was seen in weight or head circumference compared to infants born to controls. No difference was observed in prevalence of small- or large-for gestational age compared to controls. There were no differences between groups with respect to infant sex or Apgar scores at 1, 5 and 10 min, congenital malformations or stillbirth. There was furthermore no difference in pain medication use by mothers during delivery between the groups (p=0,733). Conclusion: The majority of women with HypoPT had normal pregnancy outcomes, and the overall risks must be considered to be low. Still, our findings are of importance for antenatal counseling in women with HypoPT as their risk for elective cesarean section was significantly higher compared with controls. Their children were shorter and the higher rate of smoking among HypoPT women may be an additional risk factor.