From the Guidelines
Neither Forteo (teriparatide) nor Evenity (romosozumab) is recommended for patients with End-Stage Renal Disease (ESRD) on hemodialysis due to limited safety data and potential increased risk of hypercalcemia and vascular calcification. For ESRD patients on dialysis, these osteoporosis medications should be used with extreme caution or avoided altogether. According to the most recent study 1, there are no primary randomized controlled trial data on fracture prevention efficacy and safety profiles of bone-targeting agents dedicated to patients with CKD G3b–G5D, and the use of these agents in patients with CKD G4–G5D is off label.
Key Considerations
- Teriparatide has limited safety data in severe renal impairment and may increase the risk of hypercalcemia, which is already a concern in ESRD patients 1.
- Romosozumab lacks sufficient safety data in this population and may potentially worsen vascular calcification, a common complication in ESRD 1.
- ESRD patients typically have a complex form of bone disease called Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD), which differs from typical osteoporosis and requires management of phosphate, calcium, and parathyroid hormone levels rather than standard osteoporosis treatments 1.
Treatment Approach
- For ESRD patients with bone concerns, treatment should focus on optimizing dialysis parameters, managing mineral metabolism with phosphate binders, vitamin D analogs, and calcimimetics as appropriate, under the guidance of a nephrologist 1.
- Bone mineral density testing may not accurately reflect fracture risk in this population, and treatment decisions should be individualized based on the specific type of renal osteodystrophy present 1.
From the Research
Treatment Options for ESRD Patients on Hemodialysis
- Forteo (teriparatide) and Evenity (romosozumab) are medications used to treat osteoporosis, but their use in patients with End-Stage Renal Disease (ESRD) on hemodialysis (HD) is not well established.
- According to a study published in 2016 2, once-weekly teriparatide treatment was associated with an increase in lumbar spine bone mineral density in hemodialysis patients with hypoparathyroidism and low bone mass.
- Another study from 2011 3 reported that teriparatide therapy was effective in treating severe and prolonged hypocalcemia after kidney transplantation in patients previously submitted to parathyroidectomy.
- A case report from 2015 4 described the use of teriparatide in a hemodialysis patient with low-turnover bone disease, resulting in improved bone formation and reduced fracture risk.
- However, there is limited information available on the use of Evenity (romosozumab) in ESRD patients on hemodialysis.
Safety and Efficacy Considerations
- The use of teriparatide in ESRD patients on hemodialysis requires careful monitoring of adverse events, such as transient hypotension and vomiting 2.
- The efficacy and safety of teriparatide in this population are not well established, and larger studies are needed to determine its effectiveness 4.
- The management of ESRD associated with systemic rheumatic diseases requires a multidisciplinary approach, involving collaboration between rheumatologists and nephrologists 5.
Current Recommendations
- There is no clear recommendation for the use of Forteo (teriparatide) or Evenity (romosozumab) in patients with ESRD on hemodialysis, and treatment decisions should be made on a case-by-case basis.
- Further research is needed to establish the safety and efficacy of these medications in this population.