Effects of PTH(1–84) therapy on muscle function and quality of life in hypoparathyroidism: results from a randomized controlled trial

Sikjær, Tanja; Rolighed, Lars; Heß, Alexander; Fuglsang-Frederiksen, Anders; Mosekilde, Leif; Rejnmark, Lars

doi:10.1007/s00198-014-2677-6

Cited by 117 publications

(134 citation statements)

References 36 publications

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“…Whereas a cohort study showed improvement in QoL compared to baseline after treatment with rhPTH (52), an advantage in QoL of therapy with rhPTH compared to placebo could not be shown in a RCT (53). No studies reported on disability or sick leave.…”

Section: Study Endpointsmentioning

confidence: 91%

“…Severe vitamin D deficiency is associated with symptoms of myopathy, and patients with HypoPT often have neuromuscular complaints (4,38,53). To ensure that symptoms are not caused by low vitamin D levels, it seems reasonable to ensure an adequate vitamin D status (55).…”

Section: R26 We Suggest Aiming At An Adequate Vitamin D Status (4bbb)mentioning

confidence: 99%

“…Treatment with rhPTH reduces the dose of activated vitamin D analogues and calcium supplements needed to remain at target levels of biochemical indices. However, long-term beneficial effects have so far not been shown in RCTs examining other outcomes such as hypercalciuria, renal complications or QoL (24,51,53). A markedly improved well-being has been reported in response to rhPTH therapy in case reports and in subgroups of patients included in trials on rhPTH therapy (24,43,52).…”

Section: R27mentioning

confidence: 99%

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European Society of Endocrinology Clinical Guideline: Treatment of chronic hypoparathyroidism in adults

Bollerslev¹,

Rejnmark²,

Marcocci³

et al. 2015

European Journal of Endocrinology

384

411

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Hypoparathyroidism (HypoPT) is a rare (orphan) endocrine disease with low calcium and inappropriately low (insufficient) circulating parathyroid hormone levels, most often in adults secondary to thyroid surgery. Standard treatment is activated vitamin D analogues and calcium supplementation and not replacement of the lacking hormone, as in other hormonal deficiency states. The purpose of this guideline is to provide clinicians with guidance on the treatment and monitoring of chronic HypoPT in adults who do not have end-stage renal disease. We intend to draft a practical guideline, focusing on operationalized recommendations deemed to be useful in the daily management of patients. This guideline was developed and solely sponsored by The European Society of Endocrinology, supported by CBO (Dutch Institute for Health Care Improvement) and based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) principles as a methodological base. The clinical question on which the systematic literature search was based and for which available evidence was synthesized was: what is the best treatment for adult patients with chronic HypoPT? This systematic search found 1100 articles, which was reduced to 312 based on title and abstract. The working group assessed these for eligibility in more detail, and 32 full-text articles were assessed. For the final recommendations, other literature was also taken into account. Little evidence is available on how best to treat HypoPT. Data on quality of life and the risk of complications have just started to emerge, and clinical trials on how to optimize therapy are essentially non-existent. Most studies are of limited sample size, hampering firm conclusions. No studies are available relating target calcium levels with clinically relevant endpoints. Hence it is not possible to formulate recommendations based on strict evidence. This guideline is therefore mainly based on how patients are managed in clinical practice, as reported in small case series and based on the experiences of the authors. (2015) 173, G1-G20 European Journal of Endocrinology Summary of recommendationsThe recommendations are worded as recommend (strong recommendation) and suggest (weak recommendation). We formally graded only the evidence underlying recommendations for therapeutic choices and target calcium levels. The quality of evidence behind the recommendations is classified as very low (4BBB), low (44BB), moderate (444B) and strong (4444). See further section 'Summary of methods used for guideline development'. European Journal of EndocrinologyClinical Practice Guideline J Bollerslev, L Rejnmark and others ESE guideline on treatment of chronic HypoPT

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Section: Study Endpointsmentioning

confidence: 91%

Section: R26 We Suggest Aiming At An Adequate Vitamin D Status (4bbb)mentioning

confidence: 99%

Section: R27mentioning

confidence: 99%

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European Society of Endocrinology Clinical Guideline: Treatment of chronic hypoparathyroidism in adults

Bollerslev¹,

Rejnmark²,

Marcocci³

et al. 2015

European Journal of Endocrinology

384

411

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“…Рандоми зи ро ван-ное исследование применения ПТГ(1-84) в дозе 100 мкг/сут не выявило повышения мышечной силы и качества жизни у паци-ентов в течение 6 мес терапии [55]. Вместе с тем наиболее продолжительное пятилет-нее исследование показало повышение ка-чества жизни пациентов с гипопаратиреозом на фоне терапии ПТГ(1-84) в дозе 100 мкг 1 раз в два дня [56].…”

Section: рекомбинантный человеческий птг(1-84)unclassified

Hypoparathyroidism: disease update and new methods of treatment

et al. 2017

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Ключевые слова : гипопаратиреоз, гипокальциемия, паратиреоидный гормон, гиперфосфатемия, терипаратид, рекомбинантный человеческий паратиреоидный гормон 1-84. Hypoparathyroidism is characterized by hypocalcaemia and normal or low levels of parathyroid hormone (PTH). The most common cause of hypoparathyroidism is damage to the parathyroid glands during anterior neck surgery. Conventional management of hypoparathyroidism is focused upon maintaining the serum calcium with oral calcium and active vitamin D, often requiring high doses and giving rise to concerns about long-term consequences including extracellular calcification and kidney stones. With current treatment, patients may suffer from large swings in serum calcium and are at a substantial risk of chronic renal failure, extracellular calcification. Replacement therapy of recombinant human PTH(1-84) can open up new opportunities for better control and improvement of quality of life.

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“…However, a significant beneficial effect of PTH-replacement therapy has so far not been documented in double-blinded randomized trials. The two largest double-blinded trials performed so far compared effects of 6 months of replacement therapy with PTH(1-84) with placebo [5,6]. In one of the trials, several participants, however, develop hypercalcemia in response to PTH(1-84) therapy, which may have blunted potential beneficial effects [5].…”

mentioning

confidence: 99%

Quality of life in hypoparathyroidism

Rejnmark

2017

Endocrine

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Effects of PTH(1–84) therapy on muscle function and quality of life in hypoparathyroidism: results from a randomized controlled trial

Abstract: Overall, our data do not support an immediate beneficial effect of PTH replacement therapy on muscle function or QoL. A high frequency of hypercalcemia among our patients may have compromised the potential beneficial effects of reversing the state of PTH insufficiency.

Cited by 117 publications

References 36 publications

European Society of Endocrinology Clinical Guideline: Treatment of chronic hypoparathyroidism in adults

European Society of Endocrinology Clinical Guideline: Treatment of chronic hypoparathyroidism in adults

Hypoparathyroidism: disease update and new methods of treatment

Quality of life in hypoparathyroidism

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