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Related Experiment Videos

Alendronate/colecalciferol.

Neil A Reynolds1, Monique P Curran

  • 1Adis International Inc., Yardley, Pennsylvania, USA. demail@adis.com

Treatments in Endocrinology
|December 2, 2005
PubMed
Summary
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Alendronate/colecalciferol effectively treats osteoporosis by improving vitamin D levels without altering bone turnover markers. This combination therapy shows a similar safety profile to alendronate alone, making it a well-tolerated option for bone health.

Area of Science:

  • Pharmacology
  • Endocrinology
  • Bone Metabolism

Background:

  • Osteoporosis is a significant public health concern, increasing fracture risk.
  • Vitamin D deficiency is common in osteoporosis patients, potentially impacting treatment efficacy.
  • Alendronate is a bisphosphonate used for osteoporosis, while colecalciferol is a vitamin D precursor.

Purpose of the Study:

  • To evaluate the efficacy and safety of a fixed-dose combination tablet of alendronate/colecalciferol (70 mg/2800 IU) once weekly.
  • To compare the effects of alendronate/colecalciferol versus alendronate alone on vitamin D levels and bone turnover markers.
  • To assess the safety profile of the combination therapy in patients with osteoporosis.

Main Methods:

  • A 15-week, randomized, double-blind, multicenter study was conducted.

Related Experiment Videos

  • Patients with osteoporosis received either alendronate/colecalciferol 70 mg/2800 IU once weekly or alendronate alone once weekly.
  • Serum 25-hydroxyvitamin D3 levels and bone turnover markers were measured. Adverse events were recorded.

    • Main Results:

    • The proportion of patients with serum 25-hydroxyvitamin D3 levels <15 ng/mL was significantly lower in the alendronate/colecalciferol group compared to the alendronate-alone group.
    • No significant differences in bone turnover markers were observed between the two treatment groups.
    • The treatment-related adverse event profile was similar for both once-weekly alendronate/colecalciferol and once-weekly alendronate.

    Conclusions:

    • Once-weekly alendronate/colecalciferol 70 mg/2800 IU is effective in increasing vitamin D levels in patients with osteoporosis.
    • The combination therapy demonstrates a comparable safety profile to alendronate monotherapy.
    • This fixed-dose combination offers a convenient and effective option for managing osteoporosis, particularly in patients with or at risk of vitamin D deficiency.