Investigation of the diurnal variation in bone resorption for optimal drug delivery and efficacy in osteoporosis with oral calcitonin
2008

Timing of Oral Calcitonin for Osteoporosis Treatment

Sample size: 81 publication 10 minutes Evidence: moderate

Author Information

Author(s): Karsdal MA, Byrjalsen I, Riis BJ, Christiansen C

Primary Institution: Nordic Bioscience A/S

Hypothesis

Does the timing of oral calcitonin administration affect its efficacy in suppressing bone resorption in postmenopausal women?

Conclusion

Orally administered 0.8 mg of salmon calcitonin is effective in suppressing serum CTX regardless of the time of dosing, with pre-dinner dosing showing the best results.

Supporting Evidence

  • Morning and pre-dinner dosing led to comparable concentration of sCT of 45 pg/ml.
  • Pre-dinner dosing resulted in optimum efficacy response corresponding to an overall suppression of bone resorption by 25%.
  • The maximum difference from placebo was observed 1 to 3 hours post-dose with a 40 to 50% suppression after morning dose.

Takeaway

Taking a medicine called calcitonin at different times of the day can change how well it works to help bones, and taking it before dinner seems to be the best time.

Methodology

The study was a randomized, double-blind, double-dummy, placebo-controlled, phase I study assessing the pharmacokinetic and pharmacodynamic profiles of oral salmon calcitonin in healthy postmenopausal women.

Potential Biases

No randomization of subjects may introduce bias in the comparisons between dosing times.

Limitations

Comparisons between the three dosing times may be affected by bias due to lack of randomization.

Participant Demographics

Healthy postmenopausal women aged 40–70 years.

Statistical Information

P-Value

p<0.001

Confidence Interval

69% to 120%

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1472-6904-8-12

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