Phase IV randomized preference study in patients eligible for calcium and vitamin D supplementation

Area of Science:

• Pharmacology
• Clinical Medicine
• Patient-Reported Outcomes

Background:

• Supplement formulation significantly impacts patient adherence and clinical outcomes for chronic conditions like osteoporosis.
• Understanding patient preference for calcium/vitamin D supplements is crucial for optimizing treatment strategies.

Purpose of the Study:

• To compare patient preference, acceptability, and tolerability of a reformulated Calcichew D3 against Adcal-D3 and Kalcipos-D.
• To evaluate the efficacy of different calcium/vitamin D formulations in a patient population.

Main Methods:

• A phase IV, randomized, open-label, cross-over study involving 276 patients across nine UK and German sites.
• Patients received two 2-week treatment sequences comparing Calcichew D3 formulations with respective comparators.
• Acceptability was rated using visual analogue scales, and treatment preference was assessed post-study.

Main Results:

• A statistically significant preference was observed for Calcichew D3 500/400 over Adcal-D3 (77.6% preference; odds ratio 3.46) and for Calcichew D3 500/800 over Kalcipos-D (63.2% preference; odds ratio 1.72).
• Adverse events were primarily gastrointestinal and comparable across treatment groups.
• The reformulated Calcichew D3 demonstrated acceptable tolerability consistent with its known profile.

Conclusions:

• Patients showed a clear preference for both Calcichew D3 500/400 and Calcichew D3 500/800 over their respective comparators in this short-term trial.
• The observed trend towards better compliance with preferred Calcichew D3 warrants further investigation in longer-term studies.