Fosamax Autoimmune Disease Considerations: What Clinicians and Patients Need to Know

What does the label actually cover?

The listed indications are postmenopausal osteoporosis treatment and prevention, increasing bone mass in men with osteoporosis, glucocorticoid-induced osteoporosis, and Paget's disease of bone [1]. Autoimmune disease itself is not one of them [1]. For someone with an autoimmune disease, the glucocorticoid-induced osteoporosis indication applies when they take prednisone-equivalent 7.5 mg/day or more and have low bone mineral density [1].

Corticosteroids change which warnings matter

Osteonecrosis of the jaw. Corticosteroids appear on the label's risk-factor list alongside invasive dental procedures, cancer, chemotherapy, angiogenesis inhibitors, poor oral hygiene, periodontal disease, anemia, coagulopathy, infection and ill-fitting dentures, and risk may rise with duration of exposure [1]. For patients who need invasive dental work, the label says stopping the bisphosphonate may reduce ONJ risk and that the treating physician and oral surgeon decide the plan for each patient [1].

Atypical femur fractures. The label notes glucocorticoids may also induce these fractures, and that any patient with bisphosphonate exposure and new thigh or groin pain should be evaluated to rule out an incomplete femur fracture [1]. The label also says adequate calcium and vitamin D intake is especially important in patients receiving glucocorticoids [1].

Do bisphosphonates affect immune function?

The immune-cell findings attached to these drugs come from research into how osteonecrosis of the jaw develops. That review described antiresorptive effects plus effects of bisphosphonates on gamma-delta T cells and on monocyte and macrophage function, alongside local bacterial infection, inflammation and necrosis [2]. Those findings concern jaw injury and are not measurements of infection risk in people taking oral alendronate.

Upper GI risk, NSAIDs and dosing

Alendronate is contraindicated in esophageal abnormalities that delay emptying, such as stricture or achalasia, and in anyone who cannot stand or sit upright for at least 30 minutes [1]. The label advises caution with active upper GI problems such as Barrett's esophagus, dysphagia, gastritis, duodenitis or ulcers, and says patients should stop and seek medical attention for difficulty or pain on swallowing, retrosternal pain, or new or worsening heartburn [1].

The label says NSAIDs may be taken with alendronate: in a 3-year trial of 2,027 patients, most of whom used NSAIDs, upper GI events matched placebo at 5 or 10 mg daily, though it still advises caution [1]. The label's dosing instructions are to take it at least 30 minutes before the first food, drink or medication of the day with 6 to 8 ounces of plain water, and to stay upright for 30 minutes and until after the first food [1].

Kidney function and how long to treat

The label says alendronate is not recommended when creatinine clearance is below 35 mL/min, and no dose adjustment is needed between 35 and 60 mL/min [1]. It also says the optimal duration of use has not been determined and that low-fracture-risk patients should be considered for discontinuation after 3 to 5 years [1]. The ASBMR task force suggests reassessing risk after 5 years of oral therapy, continuing up to 10 years with periodic evaluation in high-risk women, and a 2 to 3 year holiday for women not at high risk after 3 to 5 years [3].