Starting Alendronate in an 87-Year-Old Woman with Osteoporosis

Direct Recommendation

Yes, initiate alendronate 70 mg once weekly in this 87-year-old woman if she has confirmed osteoporosis (T-score ≤ -2.5) or prior fragility fracture, provided her creatinine clearance is ≥35 mL/min, she can comply with strict dosing instructions (remain upright 30 minutes, take with full glass of water), and has no active esophageal disease. 1

However, the decision requires careful consideration of her ability to adhere to dosing requirements and her overall life expectancy, as benefits begin after 9-18 months of treatment. 2

Patient Selection Criteria

Indications for Treatment

Postmenopausal women with T-score ≤ -2.5 at lumbar spine, femoral neck, total hip, or distal radius should be offered alendronate. 1
Prior fragility fracture regardless of T-score is an indication for therapy, as 60% of osteoporotic fractures occur in patients with T-scores > -2.5. 1
At age 87, this patient is at very high baseline fracture risk, which strengthens the indication for treatment. 2

Absolute Contraindications That Must Be Excluded

Creatinine clearance < 35 mL/min/1.73 m² – alendronate is absolutely contraindicated due to drug accumulation risk and lack of safety data. 1, 3
Esophageal abnormalities that delay esophageal emptying (strictures, achalasia, severe motility disorders). 1, 3
Inability to stand or sit upright for at least 30 minutes after dosing. 1, 3
Uncorrected hypocalcemia – must be corrected before initiating therapy. 1, 3
Active upper GI disease including Barrett's esophagus, active esophagitis, gastritis, duodenitis, or peptic ulcer disease. 3

Critical Pre-Treatment Requirements

Mandatory Calcium and Vitamin D Supplementation

Check serum 25(OH)D levels before starting and correct deficiency to prevent hypocalcemia, targeting ≥30 ng/mL. 1
For 25(OH)D < 30 ng/mL: Give ergocalciferol 50,000 IU weekly for 8 weeks, then recheck levels before initiating alendronate. 1
Ongoing supplementation: Provide 1,000-1,200 mg elemental calcium daily and 800-1,000 IU vitamin D daily, administered at least 30 minutes apart from alendronate. 1
Inadequate calcium and vitamin D supplementation reduces treatment efficacy and increases hypocalcemia risk. 1

Renal Function Assessment

Measure creatinine clearance – do not use alendronate if CrCl < 35 mL/min. 1, 3
No dose adjustment needed for CrCl ≥35 mL/min. 1

Dental Evaluation

Perform comprehensive dental examination before starting therapy when feasible to reduce osteonecrosis of the jaw (ONJ) risk. 1
Complete any necessary dental work before initiating bisphosphonates. 1

Dosing Regimen and Administration

Standard Dosing

Alendronate 70 mg once weekly is the standard therapeutic dose for osteoporosis treatment. 1
Alternative formulation: Alendronate 70 mg plus cholecalciferol 2,800 IU or 5,600 IU once weekly can ensure adequate vitamin D. 1

Critical Administration Instructions to Prevent Esophageal Injury

Take with 6-8 ounces (180-240 mL) of plain water upon arising in the morning, before any food or beverages. 1, 3, 4
Remain fully upright (standing or sitting) for at least 30 minutes after swallowing the tablet and until the first food of the day has been consumed. 1, 3, 4
Do not lie down during or after ingestion until 30 minutes have passed and food has been eaten. 3, 4
Swallow tablet whole – do not chew, crush, or suck on it. 3
Discontinue immediately if dysphagia, odynophagia, retrosternal pain, or new/worsening heartburn develops. 3

Special Consideration for This 87-Year-Old Patient

Assess cognitive ability and physical capability to follow these strict dosing instructions. 2
If the patient has difficulty with adherence, irregular appointment-keeping, or cannot reliably remain upright for 30 minutes, consider alternative routes such as yearly intravenous zoledronic acid (though cost may be prohibitive). 2
In patients with mental disability or severe frailty, alendronate should only be used under appropriate supervision. 3

Expected Benefits and Time to Benefit

Fracture Risk Reduction

Vertebral fractures reduced by 49-53% over 12-36 months. 1
Hip fractures reduced by 33-50% over 12-36 months. 1
Time to benefit: Incremental benefit begins at approximately 9-18 months, with significant benefit by 3 years. 2

Benefit-Risk Calculation for This Patient

If baseline 10-year risk of major osteoporotic fracture is 12% (per FRAX), her 3-year risk is approximately 3%. 2
With bisphosphonate treatment, absolute risk reduction (ARR) would be approximately 1.5% over 3 years. 2
Number needed to treat (NNT) to prevent one fracture is 18 at 4 years for patients with T-score worse than -2.5. 2
At age 87, life expectancy and quality of life considerations are paramount – the patient must live long enough to realize the benefit. 2

Treatment Duration and Monitoring

Standard Duration

Treat for 5 years as the standard duration, then reassess fracture risk to decide whether to continue or initiate a drug holiday. 1, 5
Do not routinely monitor BMD during the initial 5-year treatment period, as fracture reduction occurs even without BMD increases. 1

Reassessment After 5 Years

Patients without high-risk features (no hip/vertebral fractures during treatment, hip T-score > -2.5 after treatment) may consider a drug holiday. 5
High-risk patients (age >80, previous hip/vertebral fractures, ongoing glucocorticoid use, T-score ≤ -2.5 despite treatment) should continue therapy beyond 5 years. 5
Given this patient's age of 87, she is in the very high-risk category and would likely benefit from continued therapy if tolerated. 5

Rare but Serious Long-Term Adverse Effects

Osteonecrosis of the Jaw (ONJ)

Incidence with osteoporosis-dose alendronate: < 1 to 28 cases per 100,000 person-years. 1, 3
Risk increases with duration beyond 2 years and with invasive dental procedures. 1, 3
Prevention: Complete dental work before starting therapy; avoid unnecessary invasive oral surgery while on treatment. 1
Management: If ONJ develops, discontinue bisphosphonate and refer to oral surgeon. 3

Atypical Femoral Fractures

Incidence: 3.0 to 9.8 cases per 100,000 patient-years. 1, 5
Risk increases significantly after 5 years of continuous use, escalating sharply beyond 8 years. 5
Prodromal symptoms: Dull, aching thigh or groin pain weeks to months before complete fracture. 3
Management: Evaluate any patient with thigh/groin pain for incomplete femur fracture; assess contralateral limb; consider interrupting therapy. 3

Esophageal Adverse Events

Esophagitis, esophageal ulcers, and erosions can occur, occasionally with bleeding and rarely with stricture or perforation. 3, 4
Risk factors: Lying down after taking medication, swallowing with insufficient water, continuing medication after symptoms develop, preexisting esophageal disorders. 3, 4
Incidence in clinical trials: Esophageal adverse events were uncommon (2.0% placebo vs 4.6% alendronate 10 mg), with no serious events or discontinuations in Phase III trials. 6
Post-marketing surveillance: Higher incidence of severe esophagitis reported, almost always associated with non-compliance with dosing instructions. 4, 6

Drug-Disease and Drug-Drug Interactions Relevant to Elderly Patients

Proton Pump Inhibitors (PPIs)

PPIs lower stomach acid, decreasing calcium absorption and potentially increasing fracture risk. 2
If this patient is on a PPI (e.g., esomeprazole for hiatal hernia), ensure adequate calcium supplementation and monitor for hypocalcemia. 2
PPIs may also decrease clopidogrel effectiveness, increasing thrombosis risk if she is on antiplatelet therapy. 2

Selective Serotonin Reuptake Inhibitors (SSRIs)

SSRIs increase serotonin levels, resulting in decreased osteoblast activity and bone loss. 2
SSRIs may more than double fracture risk, especially with long-term use. 2
If this patient is on an SSRI (e.g., escitalopram), the combined effect with osteoporosis increases fracture risk further, strengthening the indication for bisphosphonate therapy. 2

Hiatal Hernia Consideration

Bisphosphonates can aggravate hiatal hernia and increase reflux symptoms. 2
Ensure strict adherence to upright positioning for 30 minutes after dosing to minimize reflux risk. 2, 3

Common Pitfalls and How to Avoid Them

Pitfall 1: Starting Therapy Without Correcting Vitamin D Deficiency

Always check and correct vitamin D deficiency before initiating alendronate to prevent hypocalcemia and optimize efficacy. 1

Pitfall 2: Inadequate Patient Education on Dosing Instructions

Esophageal complications are almost always due to non-compliance with dosing instructions. 4, 6
Ensure the patient (and caregiver if applicable) fully understands and can comply with the requirement to remain upright for 30 minutes. 3, 4

Pitfall 3: Failing to Assess Renal Function

Do not prescribe alendronate without measuring creatinine clearance – it is contraindicated if CrCl < 35 mL/min. 1, 3

Pitfall 4: Ignoring Cognitive or Physical Limitations

In an 87-year-old with potential frailty, cognitive impairment, or poor adherence history, consider whether the patient can realistically follow dosing instructions. 2
If adherence is unlikely, do not start oral alendronate – consider alternative therapies (e.g., IV zoledronic acid annually, though cost may be prohibitive) or focus on fall prevention and calcium/vitamin D supplementation. 2

Pitfall 5: Continuing Therapy Indefinitely Without Reassessment

Do not automatically continue beyond 5 years without reassessing fracture risk and balancing benefits against rare long-term harms (ONJ, atypical fractures). 5
However, given this patient's age of 87 and very high fracture risk, she may benefit from continued therapy if tolerated. 5

Pitfall 6: Delaying Necessary Dental Work

Complete all necessary dental procedures before starting bisphosphonates to reduce ONJ risk. 1
Do not delay medically necessary dental extractions in patients already on bisphosphonates, as untreated dental infections increase ONJ risk. 5

Alternative Considerations if Alendronate is Not Appropriate

If Patient Cannot Comply with Dosing Instructions

Consider yearly intravenous zoledronic acid if cost is not prohibitive and renal function permits (CrCl ≥35 mL/min). 2
Denosumab 60 mg subcutaneously every 6 months is an alternative, especially if renal impairment (CrCl < 60 mL/min). 1
Critical warning: Never discontinue denosumab without immediately starting bisphosphonate therapy within 6 months, as rebound vertebral fractures can occur. 1, 5

If Renal Impairment (CrCl < 35 mL/min)

Switch to denosumab, which does not require renal dose adjustment. 1

Non-Pharmacologic Interventions (Always Recommended)

Calcium intake of at least 1,200 mg/day and vitamin D intake of at least 800-1,000 IU/day. 2, 1
Weight-bearing exercise and fall prevention strategies are associated with lower fracture risk. 2
Optimize management of hiatal hernia and other conditions that may increase fall risk or fracture risk. 2

Summary Algorithm for Decision-Making

Confirm diagnosis: T-score ≤ -2.5 or prior fragility fracture. 1
Exclude contraindications: CrCl ≥35 mL/min, no active esophageal disease, able to remain upright 30 minutes. 1, 3
Correct vitamin D deficiency: Check 25(OH)D, supplement if < 30 ng/mL. 1
Complete dental work before starting therapy. 1
Assess cognitive and physical ability to comply with strict dosing instructions. 2, 3
If all criteria met: Start alendronate 70 mg once weekly with mandatory calcium/vitamin D supplementation. 1
If adherence unlikely or contraindications present: Consider alternative therapies (IV zoledronic acid, denosumab) or focus on non-pharmacologic interventions. 2, 1
Monitor: Reassess fracture risk after 5 years; given age 87 and very high risk, likely continue therapy if tolerated. 5

Should I start alendronate (Fosamax) in an 87‑year‑old woman with osteoporosis, ensuring adequate calcium/vitamin D intake, creatinine clearance ≥35 mL/min, and no active esophageal or gastrointestinal disease?

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