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4. Primary hyperparathyroidism: review and recommendations on evaluation, diagnosis, and management. A Canadian and international consensus

Author

Khan, A. A., Hanley, D. A., Rizzoli, R., Bollerslev, J., Young, J.E.M, Rejnmark, L., Thakker, R., D’Amour, P., Paul, T., Van Uum, S., Shrayyef, M. Zakaria, Goltzman, D., Kaiser, S., Cusano, N. E., Bouillon, R., Mosekilde, L., Kung, A. W., Rao, S. D., Bhadada, S. K., Clarke, B. L., Liu, J., Duh, Q., Lewiecki, E. Michael, Bandeira, F., Eastell, R., Marcocci, C., Silverberg, S. J., Udelsman, R., Davison, K. Shawn, Potts, Jr, J. T., Brandi, M. L., and Bilezikian, J. P.

Published
2017
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7. Sustained improvement in renal function with palopegteriparatide in adults with chronic hypoparathyroidism: 2-year results from the phase 3 PaTHway trial

Author

Kamenicky, P., Schwarz, P., Rejnmark, L., Gosmanova, E., Khan, A., Makita, N., Takeuchi, Y., Imanishi, Y., Sprague, S., Shoback, D., Kohlmeier, L., Rubin, M., Palermo, A., Gagnon, C., Tsourdi, E., Zhao, C., Makara, M., Ominsky, M., Lai, B., Ukena, J., Sibley, C., and Shu, A.

Abstract

This post hoc analysis examines the impact of palopegteriparatide on renal function in adults with chronic hypoparathyroidism through week 104 of PaTHway, a phase 3 trial with a randomized, double-blind, placebo-controlled 26-week period and ongoing 156-week open-label extension. Changes in renal function were assessed using eGFR. At week 104, 76 of 82 participants remained in the trial. Of those, 82% had normal albumin-adjusted serum calcium levels (2.07–2.64mmol/L), 97% were independent from conventional therapy, and none required active vitamin D. Mean (SD) serum phosphate (1.1 (0.2) mmol/L) and albumin-adjusted calcium x phosphate product (2.5 (0.4) mmol2/L2) were normal. At week 104, mean (SD) eGFR was 77.8 (14.8) mL/min/1.73m2. With palopegteriparatide treatment mean eGFR increased 8.9 (11.0) mL/min/1.73m2(P<.0001) from baseline to week 52, which was sustained through week 104 (mean (SD) change from baseline 9.0 (10.3) mL/min/1.73 m2(P<0.0001)). By week 104, 61% and 44% of participants had an increase in eGFR of ≥ 5mL/min/1.73 m2and ≥ 10mL/min/1.73 m2, respectively. Palopegteriparatide normalized mean 24-hour urine calcium within 26 weeks, maintaining levels below 6.2mmol/day through week 104 (4.0 (2.3) mmol/day). No cases of nephrolithiasis were reported with palopegteriparatide. Most TEAEs were mild or moderate; no new safety signals reported. These findings show sustained renal safety of palopegteriparatide and suggest that PTH replacement with palopegteriparatide and independence from conventional therapy may not only preserve but improve renal function in adults with chronic hypoparathyroidism.

Published
2024
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11. Hypoparathyroidism

Author

Mannstadt, M, Bilezikian, JP, Thakker, RV, Hannan, FM, Clarke, BL, Rejnmark, L, Mitchell, DM, Vokes, TJ, Winer, KK, and Shoback, DM

Subjects
Adult, Male, 0301 basic medicine, Hypocalcemia, Hormone Replacement Therapy, Hypoparathyroidism, 030209 endocrinology & metabolism, General Medicine, Middle Aged, United States, Europe, Hyperphosphatemia, Parathyroid Glands, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Parathyroid Hormone, Hypercalcemia, Humans, Calcium, Female, Vitamin D, Aged
Abstract

Hypoparathyroidism is a disease characterized by inadequately low circulating concentrations of parathyroid hormone (PTH) resulting in low calcium levels and increased phosphate levels in the blood. Symptoms of the disease result from increased neuromuscular irritability caused by hypocalcaemia and include tingling, muscle cramps and seizures. The most common cause of the disease is inadvertent removal of, or injury to, the parathyroid glands during neck surgery, followed by genetic, idiopathic and autoimmune aetiologies. Conventional treatment includes activated vitamin D and/or calcium supplements, but this treatment does not fully replace the functions of PTH and can lead to short-term problems (such as hypocalcaemia, hypercalcaemia and increased urinary calcium excretion) and long-term complications (which include nephrocalcinosis, kidney stones and brain calcifications). PTH replacement has emerged as a new treatment option. Clinical trials using human PTH(1-34) and PTH(1-84) showed that this treatment was safe and effective in studies lasting up to 6 years. Recombinant human PTH(1-84) has been approved in the United States and Europe for the management of hypoparathyroidism; however, its effect on long-term complications is still being evaluated. Clinical practice guidelines, which describe the consensus of experts in the field, have been published and recognize the need for more research to optimize care. In this Primer, we summarize current knowledge of the prevalence, pathophysiology, clinical presentation and management of hypoparathyroidism.

Published
2021

12. Maternal and infant vitamin D status during the first 9 months of infant life--a cohort study

Author

Streym, S. vid, Moller, U. Kristine, Rejnmark, L., Heickendorff, L., Mosekilde, L., and Vestergaard, P.

Subjects
Alfacalcidol -- Analysis -- Measurement, Calcifediol -- Analysis -- Measurement, Vitamin D -- Analysis -- Measurement, Vitamin D deficiency -- Risk factors, Pregnant women -- Health aspects, Infants (Newborn) -- Health aspects, Food/cooking/nutrition, Health
Abstract

BACKGROUND/OBJECTIVES: The objective of this study was to assess vitamin D status and possible consequences of low plasma 25-hydroxyvitamin D (25OHD) levels in a population of healthy mothers and their infants. SUBJECTS/METHODS: A total of 107 women aged 24-41 years gave birth to 108 infants. They were followed up three times during 9 months. RESULTS: Cord blood 25OHD level (43.3 ± 20.4 nmol/l) on average was 62 ± 16% of maternal levels (73.3 ± 30.7 nmol/l), measured 1-2 weeks postpartum. Cord blood 25OHD correlated positively with maternal 25OHD levels (r = 0.83, P < 0.001). At birth, 23% of mothers and 61% of infants had 25OHD < 50 nmol/l. Vitamin D deficiency (25OHD < 25 nmol/l) was present in 66% of the children born by mothers with 25OHD levels below 50 nmol/l (P50nmol/l. During follow-up, most of the children (>85%) had 25OHD levels >50nmol/l, which most likely was attributable to the use of supplements, as more than 95% of the children were given daily vitamin D supplements of 10 µg of vitamin D. Cord blood parathyroid hormone levels were very low (median 0.21; interquartile range 0.11-0.33 pmol/l), with increasing levels (P CONCLUSIONS: Vitamin D deficiency is widespread in newborn. Maternal 25OHD levels above 50 nmol/l are needed to prevent vitamin D deficiency among newborn. European Journal of Clinical Nutrition (2013) 67, 1022-1028; doi: 10.1038/ejcn.2013.152; published online 4 September 2013 Keywords: vitamin D; 25-hydroxyvitamin D; infant; mothers, INTRODUCTION Vitamin D deficiency is widespread. (1,2) Pregnant and lactating women and their newborn infants are at a high risk of vitamin D deficiency. (3-12) Vitamin D is involved in [...]

Published
2013
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