Calcium + Vitamin D3 Formulation
Proven to reduce fracture risk
Although calcium + vitamin D was thought to have a benefit on reducing fracture risk, until recently there were no definitive clinical trials to prove this fact. However, the National Institutes of Health (NIH) Women's Health Initiative demonstrated that OS-CAL's formulation can have a significant clinical impact on reducing bone fracture risk. Only OS-CAL is proven to reduce hip fracture risk by 29% when taken as directed.1
(n=21,406 taking ≥ 80% of study medication)
Only OS-CAL is proven to reduce hip fracture risk by 29%*1
NIH Women's Health Initiative (WHI) Calcium Plus Vitamin D3 Trial1
- n = 36,282 women, followed for an average of 7 years
- 2 randomized groups: Active and Placebo
- Active group received 500 mg calcium + 200 mg vitamin D3 (commercially available as OS-CAL)
- Dosing was bis in die (BID), or twice a day with meals
- Swallowable and chewable forms were made available, and choice of formulation was up to participant
- Study ended March 2005 with about 75% still taking at least some of their study pills
Intention to treat analysis (n = 36,282)
- Intention to treat showed that the active group had 12% fewer hip fractures (CI=0.72-1.08).
- This did not take into consideration compliance with study medication
Sub-analysis results were far more impressive (n = 21,406)1
- Compliant participant sub-analysis
- 21,406 women, taking ≥ 80% of the study medication
- A significant 29% reduction in hip fracture risk (CI=0.52-0.97)
- Improved BMD has been shown to be independent of bisphosphonate therapy1*
- The 29% reduction in hip fracture risk (active group) was observed above and beyond the possible effect of bisphosphonate therapy since both placebo and active groups had equal numbers of bisphosphonate using subjects.
- Equal number of bisphosphonate therapy in both active and placebo groups
- Improved bone mineral density and strengthening of bones† was demonstrated, especially at the hip (n = 1,731)2