• Elder G. Parathyroid hormone. Nephrology 2006 Apr;11(S1):S209-16.



• Elder G. Parathyroid hormone. Westmead NSW (Australia): CARI - Caring for Australasians with Renal Impairment; 2006 Jan. 17 p. [35 references]

This is the current release of the guideline.

• Chronic kidney disease
• End-stage kidney disease

Management
Treatment

Endocrinology
Family Practice
Internal Medicine
Nephrology
Pediatrics

Physicians

To explore the evidence on intact-parathyroid hormone levels in patients with chronic kidney disease and end-stage kidney disease

Adults and children with chronic kidney disease and end-stage kidney disease

Monitoring of intact-parathyroid hormone levels for non-invasive assessment of renal osteodystrophy

• Low bone turnover
• High bone turnover

• Low bone turnover disease
• High bone turnover disease
• Morbidity
• Cardiovascular mortality
• Mortality

Searches of Electronic Databases

Databases searched: MeSH terms and text words for parathyroid hormone were combined with MeSH terms and text words for chronic kidney disease and renal replacement therapy. These were combined with MeSH terms and text words for bone disease, bone biopsy, bone histomorphometry, bone mineral density, bone turnover markers, biochemical markers and cardiovascular disease. The searches were carried out in Medline, Embase and the Cochrane Controlled Trial Register (in May 2005) and abstracts of scientific meetings were searched for randomized controlled trials.

Latest search date: May 2005.

Not stated

Weighting According to a Rating Scheme (Scheme Given)

Levels of Evidence

Level I: Evidence obtained from a systematic review of all relevant randomized controlled trials (RCTs)

Level II: Evidence obtained from at least one properly designed RCT

Level III: Evidence obtained from well-designed pseudo-randomized controlled trials (alternate allocation or some other method); comparative studies with concurrent controls and allocation not randomized, cohort studies, case-control studies, interrupted time series with a control group; comparative studies with historical control, two or more single arm studies, interrupted time series without a parallel control group

Level IV: Evidence obtained from case series, either post-test or pretest/post-test

Review of Published Meta-Analyses
Systematic Review with Evidence Tables

Not stated

Expert Consensus

Not stated

Not applicable

A formal cost analysis was not performed and published cost analyses were not reviewed.

Comparison with Guidelines from Other Groups
Peer Review

Recommendations of Others. Recommendations regarding parathyroid hormone levels in patients with chronic kidney disease from the following groups were discussed: Kidney Disease Outcomes Quality Initiative, UK Renal Association, Canadian Society of Nephrology, European Best Practice Guidelines, and Kidney Disease Improving Global Outcomes.

Definitions for the levels of evidence (I–IV) can be found at the end of the "Major Recommendations" field.

Guidelines

1. For patients on dialysis, levels of intact-parathyroid hormone (iPTH) that are within or below the normal range of the assay are generally indicative of low bone turnover and levels of iPTH that are greater than 2 to 3 times the upper normal range of the assay are generally indicative of high bone turnover. (Level l evidence)
2. For the non-invasive assessment of renal osteodystrophy, assays for iPTH and parathyroid hormone (PTH)(1 to 84) have similar diagnostic value. (Level ll evidence)

Suggestions for Clinical Care

(Suggestions are based on Level III and IV sources)

• For patients on dialysis, normal bone turnover is generally associated with levels of iPTH that are 1 to 3 times the upper normal range of the assay. For bone, the suggested target iPTH is from 1 to 3 times the upper normal range of the assay, with most opinion favouring 2 to 3 times. (Opinion)
• Markedly elevated levels of iPTH are associated with an increased risk of cardiovascular mortality and sudden death. Values that are > 7 times the upper normal range of the iPTH assay should generally be avoided. (Level lll evidence)
• When iPTH levels are below 7 times the assay upper range, therapies to achieve bone targets for PTH that compromise target levels of serum calcium, phosphate or the calcium x phosphate product should be used with caution. (Opinion)
• PTH levels determined using assays for iPTH and PTH (1 to 84) correlate closely. However, iPTH assays vary in their detection of C-terminal PTH fragments and values may differ between assays (Level lll evidence). PTH (1 to 84) assays that measure the full length polypeptide are reported to be more directly comparable. (Level lll evidence) For comparison of PTH values in multicentre clinical trials, the use of a PTH (1 to 84) assay may be preferable. (Opinion)
• In assessing bone turnover, the value of the PTH (1 to 84)/non-PTH (1 to 84) ratio remains uncertain. (Opinion)
• PTH levels should be checked monthly when changes of therapy that may influence PTH are introduced and 2 to 3 monthly in other patients on dialysis. (Opinion)
• PTH levels may respond rapidly to interventions that influence calcium, phosphate and vitamin D levels but bone and cardiovascular responses may take months to years. Bone and cardiovascular outcomes are more likely to correlate with PTH trends or averaged values than with isolated PTH values. (Opinion)

Definitions:

Levels of Evidence

Level I: Evidence obtained from a systematic review of all relevant randomized controlled trials (RCTs)

Level II: Evidence obtained from at least one properly designed RCT

Level III: Evidence obtained from well-designed pseudo-randomized controlled trials (alternate allocation or some other method); comparative studies with concurrent controls and allocation not randomized, cohort studies, case-control studies, interrupted time series with a control group; comparative studies with historical control, two or more single arm studies, interrupted time series without a parallel control group

Level IV: Evidence obtained from case series, either post-test or pretest/post-test

None provided

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

• Appropriate management of intact-parathyroid hormone levels in patients with chronic kidney disease and end-stage kidney disease
• Appropriate non-invasive assessment of renal osteodystrophy in patients with chronic kidney disease and end-stage kidney disease

Not stated

An implementation strategy was not provided.

Living with Illness

Effectiveness

• Elder G. Parathyroid hormone. Nephrology 2006 Apr;11(S1):S209-16.



• Elder G. Parathyroid hormone. Westmead NSW (Australia): CARI - Caring for Australasians with Renal Impairment; 2006 Jan. 17 p. [35 references]

Not applicable: The guideline was not adapted from another source.

2006 Jan

Caring for Australasians with Renal Impairment - Disease Specific Society

Industry-sponsored funding administered through Kidney Health Australia

Not stated

Author: Grahame Elder

All guideline writers are required to fill out a declaration of conflict of interest.

This is the current release of the guideline.

None available

This NGC summary was completed by ECRI Institute on June 5, 2008. The information was verified by the guideline developer on June 11, 2008.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.