Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Alendronic acid

Generic name
Alendronic acid
Brand name
ATC Code
M05BA04

Pharmacokinetics in children

Bioavailability: 0.43%-0.56% (individually highly variable 0.18%-1.74%)

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Osteogenesis imperfecta, bone resorption inhibition
  • Oral
    • 3 years up to 18 years
      • 10 mg/day in 1 dose
      • Directions for administration:

        Take the tablet with sufficient water at least 30 minutes before breakfast sitting upright or standing and do not lie down for 30 minutes after taking it.

        • Alternative: max1-2 mg/kg per week, max. 70 mg/week
        • Only to be used by specialists with experience with this drug
        • The scientific foundations for use in children are limited.

         

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Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Dose adjustment not needed
GFR 30-50 ml/min/1.73 m2
Dose adjustment not needed
GFR 10-30 ml/min/1.73 m2
Avoid use due to lack of data
GFR < 10 ml/min/1.73 m2
Avoid use due to lack of data
Clinical consequences

If kidney function is impaired, the excretion of alendronic acid may be reduced. This increases the risk of adverse reactions.

Clinical implications:
Side effects include gastrointestinal disturbances, such as nausea, diarrhea, abdominal pain, flatulence, and cramps, especially at high doses and at the beginning of treatment.

Oral overdose may result in hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse reactions such as abdominal distension, heartburn, esophagitis, gastritis, or ulcer.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Headaches, nausea, fever, abdominal pain

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Bisphosphonates
M05BA03
M05BA07
Other drugs affecting bone structure and mineralization
M05BX05
M05BX04

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References

  1. Ward LM, et al, Single-dose pharmacokinetics and tolerability of alendronate 35- and 70-milligram tablets in children and adolescents with osteogenesis imperfecta type I, J Clin Endocrinol Metab, 2005, Jul;90(7), 4051-6
  2. DiMeglio LA, et al, Two-year clinical trial of oral alendronate versus intravenous pamidronate in children with osteogenesis imperfecta, J Bone Miner Res, 2006, Jan;21(1), 132-40
  3. Dimeglio LA, et al, A comparison of oral and intravenous bisphosphonate therapy for children with osteogenesis imperfecta, J Pediatr Endocrinol Metab, 2005, Jan;18(1), 43-53
  4. Seikaly MG, et al, Impact of alendronate on quality of life in children with osteogenesis imperfecta, J Pediatr Orthop, 2005, Nov-Dec;25(6), 786-91
  5. Rudge S, et al, Effects of once-weekly oral alendronate on bone in children on glucocorticoid treatment, Rheumatology (Oxford)., 2005, Jun;44(6), 813-8
  6. Cho TJ, et al, Efficacy of oral alendronate in children with osteogenesis imperfecta, J Pediatr Orthop, 2005, Sep-Oct;25(5), 607-12
  7. Lethaby C, et al, Bisphosphonate therapy for reduced bone mineral density during treatment of acute lymphoblastic leukemia in childhood and adolescence: a report of preliminary experience, J Pediatr Hematol Oncol, 2007, Sep;29(9), 613-6
  8. Wiernikowski JT, et al, Alendronate for steroid-induced osteopenia in children with acute lymphoblastic leukaemia or non-Hodgkin's lymphoma: results of a pilot study, J Oncol Pharm Pract, 2005, Jun;11(2), 51-6
  9. Vyskocil V, et al, Effect of alendronate therapy in children with osteogenesis imperfecta, Joint Bone Spine, 2005, Oct;72(5), 416-23
  10. NKFK working group Acute Kidney impairment, Extrapolation of KNMP risk analysis "Impaired renal function" for adults to children, 20 Dec 2021
  11. NKFK working group Acute Kidney impairment, Extrapolation of KNMP risk analysis "Impaired renal function" for adults to children, 20 Dec 2021

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Changes

Changes