Efficacy and safety of ossein-hydroxyapatite complex versus calcium carbonate to prevent bone loss

Figures & data

Figure 1. Study flow chart. CC, calcium carbonate; OHC, ossein-hydroxyapatite complex.

Table 1. Baseline characteristics of the two study groups.

Variable	OHC (n = 629)	CC (n = 222)	p-Value
Age (years), mean (SD)	47.3 (3.0)	47.1 (2.8)	0.485
Number of children (range 0–12), mean (SD)	1.9 (1.0)	1.9 (1.2)	0.627
Concomitant treatment (not calcium supplements), n (%)	131 (20.8)	41 (18.5)	0.452
Age at menarche (years), mean (SD)	12.2 (1.4)	12.3 (1.4)	0.268
Past contraceptive treatment, n (%)	213 (42.6)	86 (45.7)	0.458
Duration (years), mean (SD)	7.0 (4.4)	6.6 (4.5)	0.572
Menstrual cycle
Regular (last 12 months), n (%)	191 (30.9)	70 (32.3)	0.531
Periodicity changes (last 3 months), n (%)	228 (36.9)	71 (32.7)	0.452
Amenorrhea (last 3–11 months), n (%)	199 (32.2)	76 (35)	0.458
Risk factors (habits)
Smoking status
Current smoking, n (%)	172 (27.9)	73 (33.2)	0.137
Cigarettes per day, mean (SD)	13.5 (8.4)	14.1 (7.5)	0.583
Smoking habit (years), mean (SD)	19.8 (7.9)	18.1 (8.7)	0.157
Former smoker, n (%)	60 (23.4)	16 (19.3)	0.429
Years after smoking cessation, mean (SD)	8.6 (6.5)	11.6 (6.4)	0.108
Frequent alcohol use	47 (7.9)	19 (8.6)	0.732
Drinks a day (units), mean (SD)	1.50 (0.76)	1.42 (0.51)	0.681
Caffeine use, n (%)	249 (44.6)	100 (50.3)	0.171
Reported calcium intake (mg/day), mean (SD)	992 (503)	996 (475)	0.973
Regular exercise, n (%)	226 (44.1)	92 (47.9)	0.358

CC, calcium carbonate; OHC, ossein-hydroxyapatite complex; SD, standard deviation.

Figure 2. Lumbar T-score change (mean) from baseline in the study arms (L2–L4). CC, calcium carbonate; OHC, ossein-hydroxyapatite complex.

Figure 3. Mean percentage change from baseline in the study arms (L2–L4). CC, calcium carbonate; OHC, ossein-hydroxyapatite complex.

Table 2. Evolution of bone mineral density (T-scores and grams per square centimeter) at the lumbar spine (n = 807).

	Ossein-hydroxyapatite complex			Calcium carbonate
Visit	n	Mean (SD)	p-Value^a	n	Mean (SD)	p-Value^a	Between-group p-Value^b
T-score
Baseline	601	−0.61 (1.11)	–	206	−0.75 (0.98)	–	0.250
V7 – baseline	299	0.01 (0.82)	0.19	107	−0.23 (0.76)	0.001	<0.001
BMD (g/cm^2)
Baseline	578	1.03 (0.15)	–	204	1.01 (0.13)	–	0.057
V7 – baseline	280	0.00 (0.11)	0.34	102	−0.03 (0.11)	<0.001	<0.001

BMD, bone mineral density; SD, standard deviation; V7, visit at 36 months of follow-up.

^a Wilcoxon test for change from baseline within groups.

^b Mann–Whitney U-test for difference between treatment groups.

Table 3. Reported adverse drug reactions.

Adverse drug reaction (ADR)	OHC (n = 629)	CC (n = 222)	p-Value
Total affected patients*	17 (2.7)	17 (7.7)	0.001
Patients with gastrointestinal complaints^a	13 (2.1)	13 (5.9)	0.005
Headache	3 (0.5)	1 (0.5)	1.000^b
Dizziness	0	1 (0.5)	0.261^b
Dysgeusia	0	1 (0.5)	0.261^b
Back pain	0	1 (0.5)	0.261^b
Eczema	1 (0.2)	0	1.000^b
Weight gain	1 (0.2)	0	1.000^b
Dry mouth	1 (0.2)	1 (0.5)	0.454^b

Data presented as n (%). CC, calcium carbonate; OHC, ossein-hydroxyapatite complex.

^a Including dyspepsia, abdominal pain, flatulence, vomiting, and esophagitis.

^b Not statistically significant.

* A patient could report more than one ADR.