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Fosamax Cognitive Function Impact: What the Evidence Actually Shows

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At a glance

  • Drug / alendronate (Fosamax), an oral bisphosphonate
  • Approved uses / postmenopausal osteoporosis, osteoporosis in men, glucocorticoid-induced osteoporosis, Paget's disease [1]
  • Mechanism / binds bone mineral and inhibits osteoclasts, so bone turnover falls [1]
  • Most common adverse reactions / abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, nausea [1]
  • Label note on mental disability / use under appropriate supervision when dosing instructions cannot be followed [1]
  • FIT result / new vertebral fractures in 8.0% vs 15.0% over 36 months [2]
  • Osteoporosis treatment dose / 70 mg once weekly or 10 mg daily; the label says to take it on arising with plain water, at least 30 minutes before the first food, drink or medicine [1]

What the Fosamax label says

The most common adverse reactions, occurring in 3% or more of patients, are abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain and nausea [1]. Memory loss and dementia are not among them. In the three-year US and multinational trials, the drug-related nervous system entries were headache (2.6% with 10 mg daily vs 1.5% with placebo) and dizziness (0% vs 1.0%) [1].

One label statement bears on this topic indirectly. In its upper gastrointestinal warnings, the label says that in patients who cannot comply with dosing instructions due to mental disability, therapy with Fosamax should be used under appropriate supervision [1]. The label's routine is specific: one 70 mg tablet once weekly or 10 mg daily, swallowed whole with 6 to 8 ounces of plain water on arising, at least 30 minutes before the first food, drink or medicine of the day, with no lying down for at least 30 minutes and until after the first food [1]. The label lists inability to stand or sit upright for at least 30 minutes as a contraindication [1].

What the fracture trials measured

FIT enrolled 2,027 women aged 55 to 81 with low bone density and an existing vertebral fracture. Participants received alendronate or placebo for 36 months [2]. New morphometric vertebral fractures occurred in 8.0% of the alendronate group and 15.0% of the placebo group (relative risk 0.53); clinically apparent vertebral fractures were 2.3% vs 5.0% [2].

FLEX randomized 1,099 postmenopausal women who had previously taken alendronate for a mean of about five years to continue treatment or switch to placebo for five more years [5]. Switching lowered total hip bone mineral density by 2.4% and spine density by 3.7% relative to continuing, though values stayed at or above pre-treatment levels [5]. Clinical vertebral fractures were 2.4% with continuing alendronate vs 5.3% with placebo, and nonvertebral fractures were 19% with continuing vs 18.9% with placebo [5]. Neither trial reported cognitive outcomes.

Frequently asked questions

Does the Fosamax label list memory loss or dementia?
Memory loss and dementia are not listed among the label's most common adverse reactions, which are abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain and nausea [1]. The trial table shows headache and dizziness among drug-related nervous system events [1]. The label also says that patients who cannot comply with dosing instructions due to mental disability should be supervised during therapy [1].
Can a person with cognitive impairment take alendronate?
The label says that in patients who cannot comply with dosing instructions due to mental disability, therapy should be used under appropriate supervision [1]. It also lists inability to stand or sit upright for at least 30 minutes as a contraindication [1].
What did the main alendronate trials report?
FIT reported fracture outcomes over 36 months in 2,027 women, with new morphometric vertebral fractures in 8.0% on alendronate vs 15.0% on placebo [2]. FLEX reported bone density, bone turnover markers and fractures over 5 additional years in 1,099 women [5].
Does alendronate interact with Alzheimer medicines?
The label interactions section covers calcium supplements and antacids, aspirin and NSAIDs [1]; it does not mention donepezil, rivastigmine, galantamine or memantine. The label says to wait at least one-half hour after alendronate before taking any other oral medicine [1].
Is alendronate prescribed to prevent dementia?
Its approved indications are treatment and prevention of postmenopausal osteoporosis, increasing bone mass in men with osteoporosis, glucocorticoid-induced osteoporosis, and Paget's disease of bone [1]. None of those indications involves cognition or dementia.

References

  1. U.S. National Library of Medicine, DailyMed. Fosamax (alendronate sodium) tablets prescribing information. Fosamax (alendronate sodium) tablets label
  2. Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC, et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet. 1996;348(9041):1535-41. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group
  3. Luckman SP, Hughes DE, Coxon FP, Graham R, Russell G, Rogers MJ. Nitrogen-containing bisphosphonates inhibit the mevalonate pathway and prevent post-translational prenylation of GTP-binding proteins, including Ras. J Bone Miner Res. 1998;13(4):581-9. Nitrogen-containing bisphosphonates inhibit the mevalonate pathway and prevent post-translational prenylation of GTP-binding proteins, including Ras
  4. Oury F, Khrimian L, Denny CA, Gardin A, Chamouni A, Goeden N, et al. Maternal and offspring pools of osteocalcin influence brain development and functions. Cell. 2013;155(1):228-41. Maternal and offspring pools of osteocalcin influence brain development and functions
  5. Black DM, Schwartz AV, Ensrud KE, Cauley JA, Levis S, Quandt SA, et al. Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial. JAMA. 2006;296(24):2927-38. Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial
Evidence overview for alendronate: Fosamax Cognitive Function Impact: What the Evidence Actually Shows