The FDA has approved a subcutaneously injected formulation of recombinant human parathyroid hormone (Natpara – NPS) as an adjunct to calcium and vitamin D to control hypocalcemia in adults with hypoparathyroidism. Natpara is an 84-amino acid single-chain polypeptide identical to native parathyroid hormone. It is the first parathyroid hormone formulation to be approved for this indication.

Cinacalcet hydrochloride (Sensipar - Amgen) has been approved by the FDA for treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis and treatment of hypercalcemia in patients with parathyroid carcinoma.

The FDA has approved abaloparatide (Tymlos – Radius Health), a synthetic analog of human parathyroid hormone related peptide, for treatment of postmenopausal women with osteoporosis who are at high risk for fracture. Abaloparatide is the second parathyroid hormone receptor agonist to be approved for this indication; teriparatide (Forteo – Lilly), a recombinant parathyroid hormone analog, was the first. They are the only drugs approved for treatment of osteoporosis that stimulate bone formation. Other drugs used for this indication inhibit bone resorption.

Palopegteriparatide (Yorvipath – Ascendis), a parathyroid hormone (PTH) 1-34 analog, has been approved by the FDA for treatment of hypoparathyroidism in adults. The parathyroid hormone analog teriparatide (Forteo, and others), which is approved for treatment of postmenopausal osteoporosis, has been used off-label for treatment of hypoparathyroidism.

Teriparatide (ter i par' a tide; Forteo - Lilly), a recombinant segment of human parathyroid hormone, has been approved by the FDA for parenteral treatment of osteoporosis in post-menopausal women, and in men with idiopathic or hypogonadal osteoporosis, who are at high risk for fracture. Teriparatide is the first approved treatment for osteoporosis that stimulates bone formation. Other drugs approved for this indication inhibit bone resorption (Treatment Guidelines from the Medical Letter 2002;1:13).

The FDA has approved extended-release (ER) calcifediol (25-hydroxyvitamin D3; Rayaldee – Opko), a prohormone of calcitriol, the active form of vitamin D3. It is indicated for treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) who have serum total 25-hydroxyvitamin D levels <30 ng/mL.

Pharmacologic treatment is recommended for postmenopausal women who have bone density T-scores (standard deviations from normal mean values in the spine, femoral neck, total hip, or distal radius) of -2.5 or below, T-scores between -1.0 and -2.5 with a history of fragility (low-trauma) fracture of the hip or spine, or T-scores between -1.0 and -2.5 with a FRAX 10-year probability of ≥3% for hip fracture or ≥20% for major osteoporotic fracture.

The FDA has approved romosozumab-aqqg (Evenity – Amgen), a sclerostin inhibitor, for once-monthly subcutaneous (SC) treatment of osteoporosis in postmenopausal women who are at high risk for fracture (history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or cannot tolerate other drugs for this indication. Romosozumab is the first sclerostin inhibitor to be approved in the US and the third drug for treatment of postmenopausal osteoporosis that stimulates bone formation; the parathyroid hormone (PTH) receptor agonists abaloparatide (Tymlos) and...

View the Comparison Table: Some Drugs for Postmenopausal Osteoporosis

The recent report of a reduction in cardiovascular mortality in patients with type 2 diabetes treated with the SGLT2 inhibitor empagliflozin (Jardiance) was published soon after the FDA issued new warnings about an increased risk of fractures with canagliflozin (Invokana).