Calcium Orotate Increases Serum Calcium and Physical Activity in Postmenopausal Osteoporotic Women

27 Oct, 20

Introduction

Menopause is one of the uncontrollable risk factors for osteoporosis. The absorption rates of elemental calcium from available calcium salts vary, resulting in great concern in osteoporotic patients. Calcium orotate is a calcium salt of orotic acid, which ensures target specific delivery of calcium due to its dissociation in the osteoblasts. Calcium orotate demonstrates beneficial effects on recalcification of bone metastases on cartilage tissue and also on osteoporosis.

Aim

This study compares the efficacy of calcium orotate with calcium carbonate + vitamin D3 in postmenopausal osteoporotic women and also evaluates the impact of the study drugs on the quality of life.

Method

Study Design

Randomized, double-blind prospective study

Patient Profile

Postmenopausal women aged >50 years with osteoporosis and non-diabetic

Treatment Strategy

The study population was randomized to receive once daily either
- Calcium carbonate 500 mg (500 mg elemental calcium) and vitamin D3 250 IU
- Calcium orotate 740 mg (152.4 mg elemental calcium)

The study was carried out for a period of 2 months
Serum calcium levels were recorded at baseline and at the end of study period
The patients were asked to fill the Oswestry Disability Index and the scores were also recorded

End Points

Increase in the serum calcium level
Decrease in mean difference of Oswestry Disability Index
Adverse events (AEs)
Serious AEs (SAEs)

Results

There was two-fold increase in the serum calcium levels after treatment for 2 months with calcium orotate as compared to calcium carbonate as seen in table 1.
The calcium orotate group showed twice the improvement in the Oswestry Disability index assessment parameters as seen in table 1. This group had remarkable increase in the activity and better symptomatic relief of osteoporotic patients.

Table 1. Comparison of efficacy endpoints

Parameters	Calcium orotate	Calcium carbonate + Vit D3	P value
Increase in Serum calcium	2.97+1.14	1.42+1.23	<0.0001
Decrease in Disability Index	26.17+15.67	9.65+7.90	<0.0001
Decrease in Neck Disability Index	26.17 15.67	11.24 10.54	0.0003
Increase in Functional Strength of Cervical Spine	4.38 1.72	2.48 1.55	<0.0001

There was no incidence of AEs and SAEs in either group

Conclusion

Treatment for 2 months with calcium orotate resulted in two-fold increase in the serum calcium levels, highly significant increased physical activity and symptomatic relief as compared to calcium carbonate + vitamin D3 in postmenopausal osteoporotic women
Treatment with calcium orotate was safe and well tolerated.

2nd International Conference on Medical, Biological and Pharmaceutical Sciences (ICMBPS'2013); June 17-18, 2013; London (UK).