What are the indications for Fosamax (alendronate) in older adults with a history of vitamin D deficiency and osteoporosis?

Fosamax (Alendronate) Indications

Fosamax is indicated for the treatment of osteoporosis in postmenopausal women to reduce hip and vertebral fractures, for osteoporosis in men, for glucocorticoid-induced osteoporosis in both sexes, for prevention of postmenopausal osteoporosis, and for Paget's disease of bone. 1, 2

Primary Treatment Indications

Postmenopausal Osteoporosis - Treatment

• Alendronate 10 mg daily or 70 mg weekly is strongly recommended as first-line therapy for postmenopausal women with known osteoporosis to reduce hip and vertebral fractures 1
• Treatment is indicated for women with:
  • T-score ≤ -2.5 at the hip or spine 1
  • History of osteoporotic fracture 1
  • FRAX 10-year risk for major osteoporotic fracture >10% (adjusted by multiplying by 1.15 if prednisone dose >7.5 mg/day) 1
  • Low-trauma fracture even without DEXA confirmation of osteoporosis 1
• Alendronate reduces vertebral fractures by 45-48%, nonvertebral fractures by 23%, and hip fractures by 53% in secondary prevention 3
• Dosing options: 5 mg daily or 35 mg weekly for prevention; 10 mg daily or 70 mg weekly for treatment 1, 2
• Alendronate/cholecalciferol combination (70 mg plus 2,800 IU or 5,600 IU weekly) is available for treatment 1

Postmenopausal Osteoporosis - Prevention

• Alendronate 5 mg daily or 35 mg weekly is indicated for prevention in postmenopausal women at risk of developing osteoporosis 1, 2
• This includes women with multiple risk factors for bone loss who have not yet developed osteoporosis 1

Osteoporosis in Men

• Alendronate is recommended for men with clinically recognized osteoporosis to reduce vertebral fractures 1
• Dosing: 10 mg daily or 70 mg weekly 2, 4
• Indicated for men with T-score ≤ -2.5 or history of fragility fracture 1

Glucocorticoid-Induced Osteoporosis

• Alendronate is first-line therapy for both men and women ≥40 years receiving glucocorticoids who are at moderate-to-high fracture risk 1
• Indicated for patients receiving prednisone ≥7.5 mg/day for ≥6 months with:
  • History of osteoporotic fracture, OR
  • T-score ≤ -2.5 at hip or spine, OR
  • FRAX-adjusted 10-year major osteoporotic fracture risk >10% 1
• For patients <40 years: indicated with history of osteoporotic fracture OR Z-score < -3 at hip/spine with prednisone >7.5 mg/day OR bone loss ≥10%/year at hip/spine with prednisone >7.5 mg/day 1
• Dosing: 5 mg or 10 mg daily 1, 2

Paget's Disease of Bone

• Alendronate 40 mg daily for 6 months is indicated for moderate to severe Paget's disease (alkaline phosphatase at least twice the upper limit of normal) 2
• Achieves normalization or ≥60% reduction in serum alkaline phosphatase in approximately 85% of patients 2

Critical Contraindications and Precautions

Absolute Contraindications

• Abnormalities of the esophagus that delay esophageal emptying 1, 5
• Inability to stand or sit upright for at least 30 minutes 1, 5
• Hypocalcemia (must be corrected before starting therapy) 1, 5
• Creatinine clearance <35 mL/min for certain formulations 1
• Hypersensitivity to alendronate 1

Special Considerations for Vitamin D Deficiency

• Vitamin D deficiency must be corrected before initiating alendronate therapy 5, 2
• In patients with vitamin D insufficiency (25[OH]D 8-20 ng/ml), alendronate 70 mg combined with vitamin D3 5,600 IU weekly is more effective than standard care at correcting deficiency and increasing BMD 6
• Target serum 25(OH)D level ≥20 ng/ml with supplementation of 600-800 IU daily 1
• Calcium supplementation of 1,000-1,200 mg/day should accompany therapy 1

Important Administration Requirements

• Must be taken on an empty stomach with a full glass of plain water (not mineral water) at least 30 minutes before first food, beverage, or other medication of the day 2, 4
• Patient must remain fully upright (sitting or standing) for at least 30 minutes after taking the medication to reduce risk of esophageal adverse events 5, 2
• Patients at increased risk of aspiration should not receive alendronate solution 1

Monitoring and Duration

• Treatment duration should be 5 years for osteoporotic women 1
• Bone density monitoring is not recommended during the 5-year treatment period 1
• Dental examination is recommended before starting therapy to reduce risk of osteonecrosis of the jaw 5

Efficacy Across Populations

• Alendronate is effective regardless of age, race, baseline bone turnover rate, baseline BMD, or concurrent use of common medications 2, 4
• Increases BMD at lumbar spine by 4.8-5.1%, femoral neck by 2.3-2.5%, and total body by 2.5% over 12 months 5, 2
• Weekly dosing (70 mg) is therapeutically equivalent to daily dosing (10 mg) 2, 7