Alendronate
Alendronate
Fosamax, Binosto
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Summary
Common uses
Osteoporosis treatment (postmenopausal, male, glucocorticoid-induced)0, Osteoporosis prevention0, Paget's disease of bone0
Pharmacy
Starting dose
Treatment 70 mg PO once weekly (or 10 mg daily); prevention 35 mg weekly (or 5 mg daily); always taken first thing in the morning with a full glass of water, remaining upright for 30 minutes
Preparations
5, 10, 35, 40, 70 mg tablets; 70 mg/75 mL oral solution; 70 mg effervescent (Binosto)
US FDA Max
70 mg/week treatment; 40 mg/d for 6 months in Paget's
Pharmacology
Routes
Oral
Onset
Bone marker reduction within weeks; BMD improvement at 1-3 years; fracture-risk reduction documented at 3-5 years
Duration
Weeks; bone retention years
Half-life
Plasma ~3 hours; bone half-life ~10 years[1]
Bioavailability
<1% (oral; further reduced by food, calcium, iron, antacids; hence the strict fasting/upright dosing rules)[1]
Pregnancy
Long-term skeletal retention is a concern given the unknown effect on developing fetal bone; generally avoided.[citation needed]
Legal status
Rx-only in US
Purported mechanism
Alendronate is a nitrogen-containing bisphosphonate that adsorbs to hydroxyapatite at sites of active bone remodeling, is taken up by osteoclasts during resorption, and inhibits farnesyl pyrophosphate synthase in the mevalonate pathway; loss of prenylation impairs osteoclast cytoskeleton and ruffled border, slowing bone resorption and shifting net remodeling toward formation.0 Drug-holiday concept (3-5 years on, 1-2 years off) emerged from FLEX and long-term safety data balancing fracture protection against atypical femoral fracture and osteonecrosis of the jaw signals[1].
References
- ↑ 1.0 1.1 1.2 FDA Prescribing Information, Fosamax (alendronate sodium), Merck, current revision. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020560s045lbl.pdf