New Guidelines on Bone Disease in Chronic Kidney Disease

New York, NY
October 1 , 2003

Patients with chronic kidney disease (CKD) should have their calcium, phosphate and intact parathyroid hormone (PTH) measured regularly in order to monitor bone metabolism and disease in CKD, according to new clinical practice guidelines from the National Kidney Foundation. The 16 guidelines, published as a supplement to the October 2003 issue of the American Journal of Kidney Diseases, recommend that vitamin D deficiency is common and should be tested if PTH levels are elevated, and that phosphate control is central to managing disorders of calcium, phosphate and PTH in CKD patients.

"Disturbances in bone and mineral metabolism have their onset in the early stages of CKD and worsen as kidney function declines," explained Shaul G. Massry, MD, professor of medicine, Keck School of Medicine, University of Southern California and chair of the work group that developed the guidelines. "These disturbances can cause bone diseases and calcium deposition in blood vessels, resulting in decreased quality of life and in many cases premature death of CKD patients. Close monitoring, early detection and appropriate management can help improve the quality of life and increase longevity of CKD patients."

According to Brian J.G. Pereira, MD, president of the National Kidney Foundation, the guidelines, developed through the foundation's Kidney Disease Outcomes Quality Initiative (K/DOQI, www.kdoqi.org), provide an integrated clinical action plan for this serious and evolving problem. Some key findings include:

• Calcium, phosphorus and parathyroid hormone (PTH) should be measured in all patients who have a glomerular filtration rate (GFR) of < 60 ml/min/1.73m ², a value that represents about half of regular kidney function. The frequency of these measurements should be based on the stage of CKD.
• Restriction of dietary phosphorus should be prescribed when serum phosphorus or plasma PTH levels are elevated above target levels.
• If the levels of serum phosphorus or plasma intact PTH cannot be controlled by dietary phosphorus restriction, phosphate binders should be prescribed. Calcium-based and other non-calcium, non-magnesium and non-aluminum based phosphate binders are effective in lowering serum phosphorus levels. In patients who remain hyperphosphatemic despite the use of either of these categories of drugs, a combination of drug therapies should be used.
• The total dose of elemental calcium provided by calcium-based phosphate binders should not exceed 1500 mg/day, and the total intake of elemental calcium (including dietary calcium) should not exceed 2000 mg/day.
• In CKD Stage 5, when a patient enters dialysis, active vitamin D sterols (calcitriol, paricalcitol, alfacalcidol or doxercalciferol) may be used if PTH is > 300 pg/ml and calcium and phosphorus values are in the recommended ranges.

Guideline Work Group

The NKF-Kidney Disease Outcomes Quality Initiative (K/DOQI) Clinical Practice Guidelines: Bone Metabolism and Disease in Chronic Kidney Disease is the culmination of three years' work reviewing evidence published in peer-reviewed medical journals by 13 volunteer experts in nephrology, kidney transplantation, pediatrics, internal medicine and nutrition.

Chronic Kidney Disease

In 2002 the NKF published Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation, Classification and Stratification that found 20 million American adults have CKD and at least 20 million more are at increased risk.

"These guidelines urge physicians to evaluate their patients with diabetes, high blood pressure or a family history of kidney disease for the presence of CKD," said Adeera Levin, MD and K/DOQI Chair. "Three simple tests: blood pressure, serum creatinine and urinalysis, along with the estimation of the patient's glomerular filtration rate (GFR) will help diagnose early kidney damage," she said.

The K/DOQI Clinical Practice Guidelines address various complications and comorbidities of CKD with the goal of improving patient outcomes. Upcoming guidelines address cardiovascular disease, blood pressure, diabetes and updates to existing guidelines on hemodialysis, peritoneal dialysis and vascular access.

Guideline Sponsors

Sponsors of the guidelines include: Primary Sponsor: Abbott Laboratories, a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals, and medical products, including devices and diagnostics. Associate Sponsors include: Amgen, a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology and Genzyme, a global biotechnology company dedicated to making a major positive impact on the lives of people with serious diseases. Implementation Sponsors include: Abbott Laboratories, Amgen, Genzyme, Bone Care International, a pharmaceutical company engaged in discovering, developing and commercializing improved vitamin D-hormone therapies to treat secondary hyperparathyroidism in patients with kidney, or renal disease, and osteoporosis, and other diseases including psoriasis and cancers of the prostate, breast and colon and Shire US, Inc., a rapidly growing international emerging pharmaceutical company with a strategic focus on four therapeutic areas -- central nervous system disorders (CNS), gastrointestinal (GI), oncology, and anti-infectives. Amgen is Founding and Principal Sponsor of NKF-K/DOQI.

The guidelines can be ordered by calling the National Kidney Foundation by calling (800) 622 - 9010 or (212) 889-2210.

About K/DOQI

The Kidney Disease Outcomes Quality Initiative (K/DOQI) provides evidence-based clinical practice guidelines developed by volunteer physicians and health care providers for all phases of kidney disease and related complications, from diagnosis to monitoring and management. K/DOQI expands the Dialysis Outcomes Quality Initiative or DOQI, a project begun by the National Kidney Foundation in 1995 and recognized throughout the world for improving the care of dialysis patients. For more information, please visit www.kdoqi.org.