Alendronate Patient Information for Osteoporosis
Recommended Dosing
For treatment of osteoporosis, alendronate 70 mg once weekly is the standard regimen, taken with a full glass of water (6–8 ounces) at least 30 minutes before the first food, beverage, or other medication of the day. 1, 2, 3
Prevention dosing: Alendronate 35 mg once weekly or 5 mg daily for postmenopausal women at risk for osteoporosis. 2, 3
Glucocorticoid-induced osteoporosis: Alendronate 5 mg daily is the standard dose; higher doses (10 mg daily or 70 mg weekly) may be used for established osteoporosis in adults ≥40 years on moderate-to-high dose glucocorticoids. 2
Cancer treatment-induced bone loss: Alendronate 70 mg once weekly is effective for patients on androgen deprivation therapy or with chemotherapy-induced ovarian failure. 2
Critical Administration Instructions
Patients must remain upright (sitting or standing) for at least 30 minutes after taking alendronate and until after eating the first food of the day to minimize esophageal irritation risk. 3
Take with a full glass of plain water (6–8 ounces) only—no coffee, juice, or mineral water. 3
Do not lie down for at least 30 minutes after taking the medication. 3
Wait at least 30 minutes before consuming any food, beverage, or other medications. 3
Failure to follow these instructions may explain treatment failure and increases risk of esophageal adverse events. 2, 3
Contraindications
Alendronate is absolutely contraindicated in patients with esophageal abnormalities that delay esophageal emptying, inability to stand or sit upright for at least 30 minutes, hypocalcemia, and creatinine clearance <35 mL/min. 2, 3
Patients with active upper gastrointestinal problems (dysphagia, esophageal stricture, achalasia) should not receive alendronate. 2, 3
Hypersensitivity to any component of the product is a contraindication. 2
For renal transplant recipients on chronic glucocorticoids, consult a metabolic bone disease specialist before initiating therapy to exclude renal osteodystrophy. 2
Essential Concurrent Supplementation
All patients on alendronate must receive adequate calcium (1000–1200 mg daily) and vitamin D (800–1000 IU daily) supplementation to optimize therapeutic outcomes and prevent hypocalcemia. 1, 2, 3
Check serum 25(OH)D levels before starting bisphosphonates; correct vitamin D deficiency (target ≥30 ng/mL) to prevent hypocalcemia. 2
For 25(OH)D levels <30 ng/mL, ergocalciferol 50,000 IU weekly for 8 weeks is recommended, then recheck levels. 2
Inadequate calcium and vitamin D supplementation may reduce treatment efficacy. 2
Treatment Duration and Monitoring
The standard treatment duration is 5 years for alendronate therapy; after 5 years, reassess fracture risk rather than automatically continuing treatment. 1, 4
Do not perform routine BMD monitoring during the initial 5-year treatment period, as fracture reduction occurs even without BMD increases. 4, 2
After 5 years, patients without high-risk features (no previous hip or vertebral fractures, hip BMD T-score >-2.5) may be eligible for a drug holiday of 3–5 years. 4, 2
High-risk patients should continue beyond 5 years: those with previous hip or vertebral fractures during treatment, multiple non-spine fractures, hip BMD T-score ≤-2.5 despite treatment, age >80 years, or ongoing glucocorticoid use ≥7.5 mg prednisone daily. 4, 2
Evidence shows that extending treatment beyond 5 years reduces vertebral fractures but NOT hip or non-vertebral fractures, while increasing long-term harm risk. 4
Common Adverse Effects
Upper gastrointestinal symptoms are the most common adverse effects, including abdominal pain (3.7%), dyspepsia (2.7%), acid regurgitation (1.9%), and nausea (1.9%), though these rates are similar to placebo in large trials. 3
Musculoskeletal pain (bone, muscle, or joint pain) occurs in approximately 2.9% of patients. 3
Mild, transient, asymptomatic decreases in serum calcium (18%) and phosphate (10%) may occur but rarely reach clinically significant levels. 3
Most adverse events are transient and do not require discontinuation. 5, 6
Rare but Serious Long-Term Risks
Osteonecrosis of the jaw (ONJ) is very rare at <1 case per 100,000 person-years with osteoporosis dosing, but risk increases with duration beyond 5 years and with recent dental surgery. 1, 4
Complete all necessary dental work before initiating or continuing bisphosphonate therapy to reduce ONJ risk. 4, 2
The most consistent risk factor for ONJ is recent dental surgery or tooth extraction. 4
Atypical femoral fractures occur at a rate of 3.0–9.8 cases per 100,000 patient-years, with risk increasing significantly after 5 years of treatment. 1, 4
Risk escalates from 1.78 per 100,000 person-years with <2 years of treatment to >100 per 100,000 with ≥8 years of treatment. 1
Asian patients face up to 8 times higher risk for atypical femoral fractures than White patients. 4
Despite increased risk, an estimated 162 osteoporosis-related fractures are prevented for every one atypical femoral fracture associated with bisphosphonate treatment. 4
If an atypical femur fracture occurs, stopping bisphosphonates reduces contralateral fracture risk (otherwise 25%). 4
Atrial fibrillation concerns: Most recent evidence suggests no increased risk, though one extension trial found higher incidence of any arrhythmia (14.1% vs 4.2%) with 9 years versus 6 years of zoledronic acid treatment. 1
Treatment Failure and Switching Therapy
If a patient experiences an osteoporotic fracture ≥12 months after starting alendronate OR shows clinically significant BMD loss after 1–2 years, switch to another class of osteoporosis medication. 2
Options include intravenous bisphosphonate, denosumab, romosozumab, or parathyroid hormone analog (teriparatide, abaloparatide). 2
When oral bisphosphonate therapy fails and poor adherence or absorption is suspected, transition to IV bisphosphonate, denosumab, romosozumab, or PTH analog. 2
Critical warning: Do NOT switch directly from denosumab to a PTH analog, as this causes transient BMD loss at hip and spine. 2
Initiating teriparatide or abaloparatide after long-term bisphosphonate use yields a blunted anabolic response but still produces measurable BMD increases. 2
Alternative Therapies
For patients with contraindications to or adverse effects from bisphosphonates, denosumab 60 mg subcutaneously every 6 months is recommended as second-line therapy. 1
Denosumab is particularly appropriate for patients with renal impairment (CrCl <60 mL/min), as it does not require renal dose adjustment. 4, 2
Never discontinue denosumab without immediately starting bisphosphonate therapy within 6 months, as rebound vertebral fractures can occur. 4, 2
Anabolic agents (teriparatide, abaloparatide, romosozumab) are reserved for patients at very high fracture risk: multiple vertebral fractures, fracture occurring after ≥18 months of adequate bisphosphonate treatment, T-score ≤-3.0 with additional risk factors, or significant bone loss (≥10% per year) despite bisphosphonate therapy. 4, 2
- Patients treated with anabolic agents must be offered an antiresorptive agent after discontinuation to preserve gains and prevent serious rebound vertebral fractures. 1, 4
Special Populations
Men with primary osteoporosis: Bisphosphonates are first-line therapy; denosumab is second-line for those with contraindications or adverse effects. 1
- Limited evidence shows radiographic vertebral fractures reduced by 140 per 1000 treated patients over ≥36 months in men. 1
Glucocorticoid-induced osteoporosis: Alendronate, risedronate, and teriparatide reduce fracture risk in patients taking glucocorticoids. 1
- Vitamin D and calcium supplementation should be initiated at the start of glucocorticoid treatment. 2
Renal insufficiency: No dose adjustment required for eGFR ≥35 mL/min/1.73 m²; alendronate is contraindicated if eGFR <35 mL/min/1.73 m². 2
Efficacy Data
Alendronate reduces vertebral fractures by 49% (pooled RR 0.51), hip fractures by 33% (pooled RR 0.67), and radiographic vertebral fractures by 140 per 1000 treated patients over 12–36 months in postmenopausal women. 1, 2