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J Clin Endocrinol Metab. 2019 Nov 1;104(11):5601-5610. doi: 10.1210/jc.2019-00893.

Therapy of Hypoparathyroidism With rhPTH(1-84): A Prospective, 8-Year Investigation of Efficacy and Safety.

Author information

1
Department of Medicine, Division of Endocrinology, College of Physicians and Surgeons, Columbia University, New York, New York.
2
Department of Medicine, Sengkang General Hospital, Singapore.
3
Unit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico, Rome, Italy.
4
Department of Medicine, Division of Endocrinology Lenox Hill Hospital, New York, New York.
5
Department of Medicine, Division of Cardiology, Wyckoff Heights Medical Center, New York, New York.

Abstract

CONTEXT:

Conventional treatment of hypoparathyroidism is associated with decreased renal function and increased bone mineral density (BMD).

OBJECTIVE:

To evaluate the effects of 8 years of recombinant human parathyroid hormone (1-84) [rhPTH(1-84)] therapy on key biochemical and densitometric indices.

DESIGN:

Prospective open-label trial.

SETTING:

Tertiary medical center.

PARTICIPANTS:

Twenty-four subjects with hypoparathyroidism.

INTERVENTION:

Treatment with rhPTH(1-84) for 8 years.

MAIN OUTCOME MEASURES:

Supplemental calcium and vitamin D requirements, serum calcium and phosphorus levels, calcium-phosphate product, urinary calcium excretion, estimated glomerular filtration rate (eGFR) and BMD.

RESULTS:

PTH therapy was associated with progressive reduction in supplemental calcium (57%; P < 0.01) and active vitamin D (76%; P < 0.001) requirements over 8 years. Serum calcium concentration was stable; urinary calcium excretion declined 38% (P < 0.01). eGFR remained stable and was related to baseline eGFR and serum calcium levels. Calcium-phosphate product was below the recommended limit; serum phosphorus remained within normal range. Lumbar spine and total hip BMD increased, peaking at 4 (mean ± SE, 4.6% ± 1.5%; P = 0.01) and 8 years (2.6% ± 1.1%; P = 0.02), whereas femoral neck BMD did not change and one-third radius BMD decreased (mean ± SE, -3.5% ± 1.1%; P = 0.001). BMD at all sites was higher throughout the 8 years than in the age- and sex-matched reference population. Hypercalcemia and hypocalcemia were uncommon.

CONCLUSION:

rhPTH(1-84) is a safe and effective treatment for hypoparathyroidism for 8 years. Long-term reductions in supplemental requirements and biochemical improvements with stable renal function are maintained.

PMID:
31310310
DOI:
10.1210/jc.2019-00893

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