From the Guidelines
For a dialysis patient with a shoulder fracture and normal PTH, calcium, and phosphate levels, I recommend standard bone protection therapy with vitamin D supplementation (cholecalciferol 1000-2000 IU daily) and calcium supplementation (calcium carbonate 500-1000 mg daily). Bisphosphonates like alendronate 70 mg weekly (with dose adjustment for renal function) may be considered after careful evaluation of fracture healing progress, typically starting 2-3 weeks post-fracture, as suggested by the Kidney Disease: Improving Global Outcomes 2017 clinical practice guideline update 1. The patient should also receive adequate pain management and appropriate orthopedic care including immobilization and rehabilitation as directed by their orthopedic specialist. Regular monitoring of calcium, phosphate, and PTH levels is essential during treatment to prevent mineral imbalances. Despite normal laboratory values, dialysis patients are at high risk for renal osteodystrophy and adynamic bone disease, which can impair fracture healing. The vitamin D supplementation helps maintain bone mineralization while calcium supports bone formation. Bisphosphonates, if used, help prevent bone resorption but must be used cautiously in renal patients due to potential accumulation and delayed fracture healing. Key considerations in managing these patients include the interplay among biochemical variables (serum phosphate, calcium, and PTH) and the potential risks and benefits of different treatment approaches, as highlighted in the guideline update 1. It is also important to note that treatment approaches for CKD–MBD should be based on serial assessments of these variables taken together, and that the use of calcium-based phosphate binders should be restricted in patients with hyperphosphatemia across the CKD spectrum 1. Overall, the goal of treatment is to prevent further bone loss, promote fracture healing, and minimize the risk of complications such as renal osteodystrophy and adynamic bone disease.
From the FDA Drug Label
In patients with advanced chronic kidney disease [i.e., estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2], including dialysis-dependent patients, evaluate for the presence of chronic kidney disease mineral and bone disorder (CKD-MBD) with intact parathyroid hormone (iPTH), serum calcium, 25(OH) vitamin D, and 1,25 (OH)2 vitamin D prior to decisions regarding Prolia treatment
Treatment with Prolia in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD
The patient has normal Parathyroid Hormone (PTH), calcium, and phosphate levels. However, denosumab (Prolia) can be considered for bone protection in dialysis patients with a shoulder fracture, but treatment should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD 2.
- The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months.
- All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily. It is essential to evaluate the patient for CKD-MBD and assess bone turnover status before initiating Prolia treatment.
From the Research
Bone Protection for Dialysis Patients with Normal PTH, Calcium, and Phosphate Levels
- For a dialysis patient with a shoulder fracture and normal Parathyroid Hormone (PTH), calcium, and phosphate levels, bone protection can be considered to prevent further fractures.
- According to 3, bisphosphonates can be efficacious for antiosteoporotic endpoints, including fractures, but their use in dialysis patients is limited due to renal clearance and potential contraindications.
- As stated in 4, oral bisphosphonates (such as risedronate) may be a safe choice for osteoporosis patients with severe chronic kidney disease (CKD) and no signs of renal osteodystrophy, but renal function and PTH should be strictly monitored.
- Denosumab, with regular monitoring of calcium and adequate vitamin D levels, or raloxifene may be alternative options for bone protection in dialysis patients, as mentioned in 4.
- It is essential to ensure that the patient does not have adynamic bone disease before starting treatment, and bone biopsies may be necessary if there is any doubt, as noted in 4.
- Calcium co-medication is crucial in bisphosphonate therapy, and a fixed-combination pack of bisphosphonates and calcium can improve patient understanding and adherence to treatment, as shown in 5.
- The efficacy and safety of medications used to prevent fractures, including bisphosphonates and denosumab, have been demonstrated in various studies, but long-term efficacy and safety data are limited, as discussed in 6.
- Vitamin D replacement therapy can also be effective in improving bone density, particularly in patients with low serum vitamin D levels, as illustrated in 7.