What is the best course of treatment for a patient with osteopenia, secondary hyperparathyroidism, and chronic kidney disease (CKD) stage 3, who has a history of constipation with calcium and vitamin D supplements, and has elevated parathyroid hormone (PTH) levels, impaired renal function, and low bone mineral density?

From the Guidelines

I recommend starting the patient on denosumab (Prolia) 60mg subcutaneously every 6 months for osteopenia with high fracture risk, along with calcitriol 0.25mcg daily to address secondary hyperparathyroidism. The patient should also take calcium citrate 600mg twice daily (instead of calcium carbonate/Oscal D) with meals to minimize constipation, and vitamin D3 2000 IU daily to optimize vitamin D levels. This patient has multiple risk factors for fracture including previous fracture history, maternal hip fracture, and low bone mineral density (neck BMD -2.1), resulting in a high FRAX score of 29% for major osteoporotic fracture. Denosumab is appropriate given the patient's CKD stage 3 (GFR 40) as it doesn't require renal dose adjustment and effectively reduces fracture risk, as supported by the K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease 1. The elevated PTH (206) with normal calcium (9.2) indicates secondary hyperparathyroidism, likely related to CKD and suboptimal vitamin D status (25-OH vitamin D 29.8, borderline sufficient), which is consistent with the findings that low 25-hydroxyvitamin D levels are associated with increased PTH levels and reduced bone mineral density 1. Calcitriol (active vitamin D) will help suppress PTH and improve calcium absorption without requiring renal activation. Calcium citrate is better tolerated than calcium carbonate (Oscal D) in patients with constipation concerns and has better absorption. Regular monitoring should include calcium, phosphorus, PTH, and vitamin D levels every 3-6 months, with renal function assessment. The patient should be counseled on fall prevention strategies and weight-bearing exercise as tolerated to further reduce fracture risk. In cases where medical management is not effective, parathyroidectomy may be considered, with total parathyroidectomy with autotransplantation (TPTX + AT) being a viable option, as it has been shown to reduce the incidence of various complications of CKD, such as stroke and cardiovascular and all-cause mortality 1.

From the FDA Drug Label

Cinacalcet treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range [see Warnings and Precautions (5.1)]. Cinacalcet is not indicated for patients with CKD not on dialysis [see Indications and Usage (1)]. In patients with secondary HPT and CKD not on dialysis, the long-term safety and efficacy of cinacalcet have not been established

The patient has CKD Stage 3 and secondary hyperparathyroidism. The FDA drug label for cinacalcet 2 states that cinacalcet is not indicated for patients with CKD who are not on dialysis. Therefore, cinacalcet is not recommended for this patient.

From the Research

Treatment Options for Osteopenia and Secondary Hyperparathyroidism

• The patient has osteopenia with a risk of major fracture, secondary hyperparathyroidism, and CKD Stage 3, with a PTH level of 206 and serum calcium of 9.2 3, 4.
• Cinacalcet has been shown to be effective in reducing PTH levels and calcium-phosphorus product in patients with secondary hyperparathyroidism, without increasing serum calcium and phosphorus concentrations 3, 5.
• The combination of cinacalcet and vitamin D has been shown to be effective in reducing serum calcium, phosphorus, and calcium-phosphorus product, without increasing the risk of adverse events 4.

Calcium and Vitamin D Supplementation

• Calcium citrate and vitamin D supplementation is recommended for the treatment of osteoporosis, with a suggested dosage of at least 1200 mg and 800 IU per day, respectively 6.
• A fixed-combination pack of bisphosphonate, calcium, and vitamin D has been shown to improve patient compliance and adherence to osteoporosis therapy 7.
• The patient's vitamin D level is 29.8, which may be inadequate for optimal bone health, and supplementation may be necessary 6.

Considerations for Treatment

• The patient's constipation with oscal D may be a consideration when choosing a calcium and vitamin D supplement, and alternative formulations such as calcium citrate may be better tolerated 6.
• The patient's CKD Stage 3 and secondary hyperparathyroidism require careful management of calcium and phosphorus levels, and cinacalcet may be a useful treatment option 3, 4, 5.