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Meta-Analysis
. 2015 Nov 12;2015(11):CD008327.
doi: 10.1002/14651858.CD008327.pub2.

Interventions for metabolic bone disease in children with chronic kidney disease

Deirdre Hahn  1 , Elisabeth M Hodson, Jonathan C Craig
Affiliations
Meta-Analysis

Interventions for metabolic bone disease in children with chronic kidney disease

Deirdre Hahn et al. Cochrane Database Syst Rev. .

Abstract

Background: Bone disease is common in children with chronic kidney disease (CKD) and when untreated may result in bone deformities, bone pain, fractures and reduced growth rates. This is an update of a review first published in 2010.

Objectives: This review aimed to examine the benefits (improved growth rates, reduced risk of bone fractures and deformities, reduction in PTH levels) and harms (hypercalcaemia, blood vessel calcification, deterioration in kidney function) of interventions (including vitamin D preparations and phosphate binders) for the prevention and treatment of metabolic bone disease in children with CKD.

Search methods: We searched the Cochrane Kidney and Transplant Specialised Register to 8 September 2015 through contact with the Trial's Search Co-ordinator using search terms relevant for this review.

Selection criteria: We included randomised controlled trials (RCTs) comparing different interventions used to prevent or treat bone disease in children with CKD stages 2 to 5D.

Data collection and analysis: Data were assessed for study eligibility, risk of bias and extracted independently by two authors. Results were reported as risk ratios (RR) or risk differences (RD) with 95% confidence intervals (CI) for dichotomous outcomes. For continuous outcomes the mean difference (MD) or standardised mean difference (SMD) with 95% confidence intervals (CI) was used. Statistical analyses were performed using the random-effects model.

Main results: This review included 18 studies (576 children); three new studies were added for this update. Adequate sequence generation and allocation concealment were reported in 12 and 11 studies respectively. Only four studies reported blinding of children, investigators or outcome assessors. Nine studies were at low risk of attrition bias and 12 studies were at low risk of selective reporting bias.Eight different interventions were compared. Two studies compared intraperitoneal (IP) with oral calcitriol. PTH levels were significantly lower with IP compared with oral calcitriol (1 study: MD -501.00 pg/mL, 95% CI -721.54 to -280.46) but the number of children with abnormal bone histology did not differ between treatments. Three studies compared intermittent with daily oral calcitriol. The change in mean height SDS (1 study: MD 0.13, 95% CI -0.22 to 0.48) and the percentage fall in parathyroid hormone (PTH) levels at eight weeks (1 study: MD -5.50%, 95% CI -32.37 to 21.37) and 12 months (1 study: MD -6.00% 95% CI -25.27 to 13.27) did not differ between treatments.Four studies compared active vitamin D preparations (calcitriol, paricalcitol, 1α-hydroxyvitamin D) with placebo or no specific treatment. One study reported vitamin D preparations significantly reduced PTH levels (-55.00 pmol/L, 95% CI -83.03 to -26.97). There was no significant difference in hypercalcaemia risk with vitamin D preparations compared with placebo or no specific treatment (4 studies, 103 children: RD 0.08 mg/dL, 95% CI -0.08 to 0.24). However, there was heterogeneity (I(2) = 55%) with one study showing a significantly greater risk of hypercalcaemia with intravenous (IV) calcitriol administration. Two studies (97 children) compared calcitriol with other vitamin D preparations and both found no significant differences in growth between preparations.Two studies compared ergocalciferol in patients with CKD and vitamin D deficiency. Elevated PTH levels developed significantly later in ergocalciferol treated children (1 study: hazard ratio 0.30, 95% CI 0.09 to 0.93) though the number with elevated PTH levels did not differ between groups (1 study, 40 children: RR 0.33, 95% CI 0.11 to 1.05).Two studies compared calcium carbonate with aluminium hydroxide as phosphate binders. One study (17 children: MD -0.86 SDS, 95% CI -2.24 to 0.52) reported no significant difference in mean final height SDS between treatments. Three studies compared sevelamer with calcium-containing phosphate binders. There were no significant differences in the final calcium, phosphorus or PTH levels between binders. More episodes of hypercalcaemia occurred with calcium-containing binders. One study reported no significant differences between calcitriol and doxercalciferol in bone histology or biochemical parameters.

Authors' conclusions: Bone disease, assessed by changes in PTH levels, is improved by all vitamin D preparations. However, no consistent differences between routes of administration, frequencies of dosing or vitamin D preparations were demonstrated. Although fewer episodes of high calcium levels occurred with the non-calcium-containing phosphate binder, sevelamer, compared with calcium-containing binders, there were no differences in serum phosphorus and calcium overall and phosphorus values were reduced to similar extents. All studies were small with few data available on patient-centred outcomes (growth, bone deformities) and limited data on biochemical parameters or bone histology resulting in considerable imprecision of results thus limiting the applicability to the care of children with CKD.

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Conflict of interest statement

  1. Elisabeth Hodson: I was the lead author on a study published in 1985 (Hodson 1985), which was eligible for and included in this review. Data extraction was carried out independently by Dr Geary and myself and all data included in the review was agreed on by both authors.

  2. Deirdre Hahn: none declared

  3. Jonathan Craig: none declared

Figures

1
1
Study flow diagram
2
2
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
1.1
1.1. Analysis
Comparison 1 Intraperitoneal versus oral calcitriol, Outcome 1 Bone disease on bone histology.
1.2
1.2. Analysis
Comparison 1 Intraperitoneal versus oral calcitriol, Outcome 2 Bone formation rate.
1.3
1.3. Analysis
Comparison 1 Intraperitoneal versus oral calcitriol, Outcome 3 PTH.
1.4
1.4. Analysis
Comparison 1 Intraperitoneal versus oral calcitriol, Outcome 4 Maximum calcium level.
1.5
1.5. Analysis
Comparison 1 Intraperitoneal versus oral calcitriol, Outcome 5 Adverse events.
1.6
1.6. Analysis
Comparison 1 Intraperitoneal versus oral calcitriol, Outcome 6 Peritonitis episodes/patient‐months.
2.1
2.1. Analysis
Comparison 2 Intermittent versus daily oral calcitriol, Outcome 1 Change in height SDS at 12 months.
2.2
2.2. Analysis
Comparison 2 Intermittent versus daily oral calcitriol, Outcome 2 Fall in PTH.
2.3
2.3. Analysis
Comparison 2 Intermittent versus daily oral calcitriol, Outcome 3 Number with fall in PTH at 8 weeks.
2.4
2.4. Analysis
Comparison 2 Intermittent versus daily oral calcitriol, Outcome 4 Mean integrated PTH at 12 months.
2.5
2.5. Analysis
Comparison 2 Intermittent versus daily oral calcitriol, Outcome 5 Kidney function.
2.6
2.6. Analysis
Comparison 2 Intermittent versus daily oral calcitriol, Outcome 6 Adverse events.
3.1
3.1. Analysis
Comparison 3 Vitamin D preparations versus placebo/no treatment, Outcome 1 Abnormal bone histology.
3.2
3.2. Analysis
Comparison 3 Vitamin D preparations versus placebo/no treatment, Outcome 2 Elevated PTH.
3.3
3.3. Analysis
Comparison 3 Vitamin D preparations versus placebo/no treatment, Outcome 3 PTH.
3.4
3.4. Analysis
Comparison 3 Vitamin D preparations versus placebo/no treatment, Outcome 4 Number with 30% fall in PTH on two occasions.
3.5
3.5. Analysis
Comparison 3 Vitamin D preparations versus placebo/no treatment, Outcome 5 Change in PTH with IV calcitriol.
3.6
3.6. Analysis
Comparison 3 Vitamin D preparations versus placebo/no treatment, Outcome 6 Hypercalcaemia.
3.7
3.7. Analysis
Comparison 3 Vitamin D preparations versus placebo/no treatment, Outcome 7 Calcium‐phosphorus product > 7.5 mg²/dL².
3.8
3.8. Analysis
Comparison 3 Vitamin D preparations versus placebo/no treatment, Outcome 8 Phosphorus > 6.5 mg/dL.
3.9
3.9. Analysis
Comparison 3 Vitamin D preparations versus placebo/no treatment, Outcome 9 Change in biochemical values.
4.1
4.1. Analysis
Comparison 4 Calcitriol versus ergocalciferol, Outcome 1 Height velocity ≥ expected.
4.2
4.2. Analysis
Comparison 4 Calcitriol versus ergocalciferol, Outcome 2 Improved bone histology.
4.3
4.3. Analysis
Comparison 4 Calcitriol versus ergocalciferol, Outcome 3 PTH.
4.4
4.4. Analysis
Comparison 4 Calcitriol versus ergocalciferol, Outcome 4 Hypercalcaemia.
4.5
4.5. Analysis
Comparison 4 Calcitriol versus ergocalciferol, Outcome 5 Biochemical values.
5.1
5.1. Analysis
Comparison 5 Ergocalciferol versus placebo/no treatment, Outcome 1 Number developing hyperparathyroidism.
5.2
5.2. Analysis
Comparison 5 Ergocalciferol versus placebo/no treatment, Outcome 2 PTH.
5.3
5.3. Analysis
Comparison 5 Ergocalciferol versus placebo/no treatment, Outcome 3 Calcium.
5.4
5.4. Analysis
Comparison 5 Ergocalciferol versus placebo/no treatment, Outcome 4 Phosphorus.
5.5
5.5. Analysis
Comparison 5 Ergocalciferol versus placebo/no treatment, Outcome 5 End 1.25(OH)D3 levels.
6.1
6.1. Analysis
Comparison 6 Calcium carbonate versus aluminium hydroxide, Outcome 1 Height SDS.
6.2
6.2. Analysis
Comparison 6 Calcium carbonate versus aluminium hydroxide, Outcome 2 Abnormal bone biopsy.
6.3
6.3. Analysis
Comparison 6 Calcium carbonate versus aluminium hydroxide, Outcome 3 Bone aluminium.
6.4
6.4. Analysis
Comparison 6 Calcium carbonate versus aluminium hydroxide, Outcome 4 PTH.
6.5
6.5. Analysis
Comparison 6 Calcium carbonate versus aluminium hydroxide, Outcome 5 ALP.
6.6
6.6. Analysis
Comparison 6 Calcium carbonate versus aluminium hydroxide, Outcome 6 Hypercalcaemia.
7.1
7.1. Analysis
Comparison 7 Sevelamer versus calcium‐containing phosphate binders, Outcome 1 PTH.
7.2
7.2. Analysis
Comparison 7 Sevelamer versus calcium‐containing phosphate binders, Outcome 2 ALP.
7.3
7.3. Analysis
Comparison 7 Sevelamer versus calcium‐containing phosphate binders, Outcome 3 Calcium‐phosphorus product.
7.4
7.4. Analysis
Comparison 7 Sevelamer versus calcium‐containing phosphate binders, Outcome 4 Calcium.
7.5
7.5. Analysis
Comparison 7 Sevelamer versus calcium‐containing phosphate binders, Outcome 5 Phosphorus.
7.6
7.6. Analysis
Comparison 7 Sevelamer versus calcium‐containing phosphate binders, Outcome 6 Bone histomorphometry.
8.1
8.1. Analysis
Comparison 8 Calcitriol versus doxercalciferol, Outcome 1 Bone histomorphometry.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Ardissino 2000 {published data only}
    1. Ardissino G, Schmitt CP, Testa S, Claris‐Appiani A, Mehls O. Calcitriol pulse therapy is not more effective than daily calcitriol therapy in controlling secondary hyperparathyroidism in children with chronic renal failure. European Study Group on Vitamin D in Children with Renal Failure. Pediatric Nephrology 2000;14(7):664‐68. [MEDLINE: ] - PubMed
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Mak 1985 {published data only}
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Pieper 2006 {published data only}
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Rianthavorn 2013 {published data only}
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Salusky 1991 {published data only}
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Salusky 1998 {published data only}
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Salusky 2005 {published data only}
    1. Hernandez J, Wesseling K, Jueppner H, Goodman WG, Gales B, Elashoff R, et al. Skeletal response to phosphate binders and intermittent oral vitamin D in dialyzed children with secondary hyperparathyroidism [abstract no: F‐FC044]. Journal of the American Society of Nephrology 2005;16:47A.
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    1. Salusky IB, Goodman WG, Elashoff R, Gales B, Shaney S, Jueppner H. Prospective comparison of calcium‐based binder versus sevelamer HCL on the control of the skeletal lesions of secondary hyperparathyroidism [abstract no: F‐PO989]. Journal of the American Society of Nephrology 2004;15:281A.
    1. Salusky IB, Goodman WG, Sahney S, Gales B, Perilloux A, Wang HJ, et al. Sevelamer controls parathyroid hormone‐induced bone disease as efficiently as calcium carbonate without increasing serum calcium levels during therapy with active vitamin D sterols. Journal of the American Society of Nephrology 2005;16(8):2501‐08. [MEDLINE: ] - PubMed
Salusky 2005a {published data only}
    1. Pereira RC, Hernandez JD, Wesseling K, Gales B, Jueppner HW, Salusky IB. Differential effect of doxercalciferol and calcitriol on skeletal lesions of secondary hyperparathyroidism [abstract no: TH‐PO133]. Journal of the American Society of Nephrology 2006;17(Abstracts):134A. [CENTRAL: CN‐00740590]
    1. Salusky I, Jueppner H, Gales B, Elashoff R, Goodman WG. Skeletal response to the treatment of secondary hyperparathyroidism: a comparison between calcitriol and 1‐Alpha‐D2 [abstract no: F‐PO643]. Journal of the American Society of Nephrology 2003;14:202A.
    1. Salusky IB, Wesseling K, Hernandez J, Lavigne JR, Zahranik RJ, Gales B, et al. Comparison between first and second generation PTH assays as predictors of bone turnover during treatment of secondary hyperparathyroidism in dialyzed children [abstract no: SA‐PO833]. Journal of the American Society of Nephrology 2005;16:739A.
    1. Wesseling‐Perry K, Harkins GC, Wang HJ, Sahney S, Gales B, Elashoff RM, et al. Response of different PTH assays to therapy with sevelamer or CaCO3 and active vitamin D sterols. Pediatric Nephrology 2009;24(7):1355‐61. [MEDLINE: ] - PMC - PubMed
    1. Wesseling‐Perry K, Jueppner H, Goodman WG, Gales B, Elasoff R, Wang H, et al. Similar predictive value of bone turnover by first and second generation PTH assays during treatment of secondary hyperparthyroidism in dialyzed children [abstract no: F‐PO980]. Journal of the American Society of Nephrology 2004;15(Oct):279A.
Salusky 2005b {published and unpublished data}
    1. Pereira RC, Hernandez JD, Wesseling K, Gales B, Jueppner HW, Salusky IB. Differential effect of doxercalciferol and calcitriol on skeletal lesions of secondary hyperparathyroidism [abstract no: TH‐PO133]. Journal of the American Society of Nephrology 2006;17(Abstracts):134A. [CENTRAL: CN‐00740590]
    1. Salusky I, Jueppner H, Gales B, Elashoff R, Goodman WG. Skeletal response to the treatment of secondary hyperparathyroidism: a comparison between calcitriol and 1‐Alpha‐D2 [abstract no: F‐PO643]. Journal of the American Society of Nephrology 2003;14:202A.
    1. Salusky IB, Wesseling K, Hernandez J, Lavigne JR, Zahranik RJ, Gales B, et al. Comparison between first and second generation PTH assays as predictors of bone turnover during treatment of secondary hyperparathyroidism in dialyzed children [abstract no: SA‐PO833]. Journal of the American Society of Nephrology 2005;16:739A.
    1. Wesseling‐Perry K, Harkins GC, Wang HJ, Sahney S, Gales B, Elashoff RM, et al. Response of different PTH assays to therapy with sevelamer or CaCO3 and active vitamin D sterols. Pediatric Nephrology 2009;24(7):1355‐61. [MEDLINE: ] - PMC - PubMed
    1. Wesseling‐Perry K, Jueppner H, Goodman WG, Gales B, Elasoff R, Wang H, et al. Similar predictive value of bone turnover by first and second generation PTH assays during treatment of secondary hyperparthyroidism in dialyzed children [abstract no: F‐PO980]. Journal of the American Society of Nephrology 2004;15(Oct):279A.
Schmitt 2003 {published data only}
    1. Schmitt CP, Ardissino G, Testa S, Claris‐Appiani A, Mehls O. Growth in children with chronic renal failure on intermittent versus daily calcitriol. Pediatric Nephrology 2003;18(5):440‐4. [MEDLINE: ] - PubMed
Shroff 2012 {published data only}
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Watson 1988 {published data only}
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References to studies excluded from this review

Ardissino 2000a {published data only}
    1. Ardissino G, Schmitt CP, Bianchi ML, Dacco V, Claris‐Appiani A, Mehls O. No difference in intestinal strontium absorption after oral or IV calcitriol in children with secondary hyperparathyroidism. The European Study Group on Vitamin D in Children with Renal Failure. Kidney International 2000;58(3):981‐8. [MEDLINE: ] - PubMed
    1. Ardissino G, Schmitt CP, Claris‐Appiani A, Bianchi ML, Dacco V, Mehls O, et al. Equal intestinal calcium absorption and greater PTH suppression with oral vs IV calcitriol bolus in children with secondary hyperparathyroidism [abstract]. Journal of the American Society of Nephrology 1997;8(Program & Abstracts):571A. [CENTRAL: CN‐00444219]
    1. Ardissino GL, Schmitt CP, Dacco V, Bianchi ML, Claris‐Appiani A, Mehls O, et al. Oral and IV calcitriol pulse are equally effective on control of serum PTH and in stimulating intestinal calcium absorption [abstract no: A2821]. Journal of the American Society of Nephrology 1996;7(9):1810. [CENTRAL: CN‐00615905]
    1. Schmitt C, Ardissino G, Bianchi M, Mehls O, European Study Group on Vit D in children with CRF. Higher intestinal calcium absorption with iv calcitriol compared to oral in children with 2º hyperparathyroidism (HPT) [abstract]. Nephrology Dialysis Transplantation 1997;12(9):A115. [CENTRAL: CN‐00677748]
Bettinelli 1986 {published data only}
    1. Bettinelli A, Bianchi ML, Aimini E, Ortolani S, Soldati L, Edefonti A. Effects of 1,25‐dihydroxyvitamin‐D3 treatment on mineral balance in children with end stage renal disease undergoing chronic hemofiltration. Pediatric Research 1986;20(1):5‐8. [MEDLINE: ] - PubMed
Choudhary 2014 {published data only}
    1. Choudhary S, Agarwal I, Seshadri MS. Calcium and vitamin D for osteoprotection in children with new‐onset nephrotic syndrome treated with steroids: a prospective, randomized, controlled, interventional study. Pediatric Nephrology 2014;29(6):1025‐32. [MEDLINE: ] - PubMed
El Husseini 2004 {published data only}
    1. Husseini A, El‐Agroudy A, El‐Sayed M, Sobh M, Ghoneim M. Treatment of bone loss in renal transplant children and adolescents [abstract]. Nephrology Dialysis Transplantation 2003;18(Suppl 4):544. [CENTRAL: CN‐00445216]
    1. Husseini A, Elagroudy A, Elsayed M, Sobh M, Ghoneim M. Treatment of bone loss with vitamin D in live related kidney transplant children and adolescents: a prospective randomized study. 41st Congress of ERA‐EDTA; 2004 May 15‐18; Lisbon (Portugal). 2004:93. [CENTRAL: CN‐00509176]
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References to other published versions of this review

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