Teriparatide in East Asian Postmenopausal Women with Osteoporosis in a Real-World Setting: A Baseline Analysis of the Asia and Latin America Fracture Observational Study (ALAFOS)

Figures & data

Figure 1 ALAFOS study design.

Notes: ^aPrescribed by treating physician at baseline visit as part of routine clinical practice; all aspects of patient care (including diagnostic and therapeutic interventions) were conducted at the discretion of the treating physicians according to their clinical judgment and local standards of medical care; ^bData collection is done during routine clinical visits.

Table 1 Baseline Characteristics and Reproductive History

Characteristic	Taiwan (N=474)	South Korea (N=379)	China (N=235)	Hong Kong (N=48)	All Patients East Asian Subregion (N=1136)
Age (years), mean (SD)	76.5 (9.9)	75.0 (9.0)	71.1 (9.2)	78.4 (8.6)	75.0 (9.6)
Body mass index (kg/m^2), mean (SD)	23.3 (4.2)	23.3 (3.8)	22.7 (3.6)	20.8 (3.2)	23.1 (3.9)
Bone mineral density (T-score), mean (SD)
Lumbar spine	−3.38 (1.19) (n=268)	−2.92 (1.41) (n=191)	−2.88 (2.16) (n=127)	−2.72 (1.78) (n=21)	−3.11 (1.54) (n=607)
Total hip	−2.76 (0.96) (n=149)	−2.15 (1.08) (n=84)	−2.72 (1.11) (n=28)	−2.74 (1.66) (n=24)	−2.58 (1.11) (n=285)
Femoral neck	−3.06 (0.74) (n=163)	−2.58 (1.09) (n=137)	−2.77 (2.16) (n=28)	−3.31 (0.79) (n=20)	−2.86 (1.09) (n=348)
Patients older than 40 years with ≥1 previous low trauma fracture, n (%)	358 (75.5%)	216 (57.0%)	176 (74.9%)	41 (85.4%)	791 (69.6%)
Patients older than 40 years with previous low trauma fracture (by number of fractures), n (%)
No fractures	116 (24.5%)	163 (43.0%)	59 (25.1%)	7 (14.6%)	345 (30.4%)
1 fracture	103 (21.7%)	126 (33.2%)	94 (40.0%)	9 (18.8%)	332 (29.2%)
2 fractures	93 (19.6%)	59 (15.6%)	36 (15.3%)	12 (25.0%)	200 (17.6%)
3 fractures	72 (15.2%)	19 (5.0%)	20 (8.5%)	8 (16.7%)	119 (10.5%)
4 fractures	51 (10.8%)	5 (1.3%)	10 (4.3%)	7 (14.6%)	73 (6.4%)
5 or more fractures	39 (8.2%)	7 (1.8%)	16 (6.8%)	5 (10.4%)	67 (5.9%)
Previous fracture sites, n (%)
Vertebral	286 (60.3%)	108 (28.5%)	109 (46.4%)	31 (64.6%)	534 (47.0%)
Non-vertebral	146 (30.8%)	111 (29.3%)	50 (21.3%)	15 (31.3%)	322 (28.3%)
Main non-vertebral^a	123 (25.9%)	78 (20.6%)	16 (6.8%)	13 (27.1%)	230 (20.2%)
Hip	82 (17.3%)	61 (16.1%)	8 (3.4%)	7 (14.6%)	158 (13.9%)
Reproductive History
Age at onset of menopause (years), mean (SD)	49.5 (5.4)	49.5 (5.4)	49.1 (4.7)	49.6 (4.4)	49.5 (5.2)
Number of fertile years^b, median (Q1, Q3), years	35.0 (31, 37)	34.0 (30, 37)	35.0 (32, 37)	35.0 (32, 39)	35.0 (31, 37)
Parity^c, n (%) patients
0	16 (3.4%)	11 (2.9%)	8 (3.4%)	5 (10.4%)	40 (3.5%)
1	16 (3.4%)	7 (1.8%)	65 (28.0%)	9 (18.8%)	97 (8.6%)
2	78 (16.5%)	74 (19.5%)	57 (24.6%)	10 (20.8%)	219 (19.3%)
3	115 (24.3%)	109 (28.8%)	60 (25.9%)	6 (12.5%)	290 (25.6%)
4	128 (27.0%)	71 (18.7%)	18 (7.8%)	9 (18.8%)	226 (19.9%)
5 or more	121 (25.5%)	107 (28.2%)	24 (10.3%)	9 (18.8%)	261 (23.0%)
Early menopause (< age 40), n (%)	19 (4.0%)	17 (4.5%)	6 (2.6%)	1 (2.1%)	43 (3.8%)
Surgical menopause, n (%)	57 (12.3%)	26 (6.9%)	11 (5.4%)	9 (18.8%)	103 (9.4%)

Notes: Percentages were calculated using n, the number of valid (not missing or unknown) responses for each item. ^aRadius, hip, humerus, tibia, pelvis and clavicle; ^bAge at menopause – age at menstruation; ^cNumber of times given birth.

Abbreviations: N, total number of patients available; n, number of patients with valid (non-missing or unknown) values; Q1, 1st quartile; Q3, 3rd quartile.

Figure 2 Percentage of patients with osteoporotic fractures after 40 years of age.

Notes: The five parts of the figure show: (A) Taiwan (N=474); (B) South Korea (N=379); (C) China (N=235); (D) Hong Kong (N=48); (E) All Patients – East Asian subregion (N=1136). Percentages were calculated using n, the number of valid (not missing or unknown) responses for each item.

Table 2 Risk Factors for Osteoporosis and Fractures, Current Comorbidities, and Concomitant Medications

Characteristic	Taiwan (N=474)	South Korea (N=379)	China (N=235)	Hong Kong (N=48)	All Patients East Asian Subregion (N=1136)
Maternal history of osteoporosis or hip fracture, n (%)	66 (26.4%)	33 (17.8%)	59 (29.9%)	1 (2.8%)	159 (23.8%)
Sight problems, n (%)	331 (71.8%)	78 (21.1%)	94 (52.8%)	27 (57.4%)	530 (50.2%)
Patients experiencing falls in the past year, n (%)	200 (43.1%)	94 (31.8%)	39 (23.4%)	21 (43.8%)	354 (36.3%)
Number of falls in the past year, n (%)
No falls	264 (56.9%)	202 (68.2%)	128 (76.6%)	27 (56.3%)	621 (63.7%)
1 fall	110 (23.7%)	74 (25.0%)	26 (15.6%)	16 (33.3%)	226 (23.2%)
2 falls	44 (9.5%)	11 (3.7%)	10 (6.0%)	3 (6.3%)	68 (7.0%)
3 or more falls	46 (9.9%)	9 (3.0%)	3 (1.8%)	2 (4.2%)	60 (6.2%)
Hours of exercise per week, mean (SD)	2.6 (3.4)	3.1 (5.6)	6.3 (8.6)	2.9 (3.2)	3.4 (5.4)
Use of arms when standing up from a chair, n (%)	340 (72.3%)	257 (68.9%)	131 (67.2%)	30 (62.5%)	758 (69.8%)
Immobilized for >12 months, n (%)	5 (1.1%)	6 (1.6%)	6 (3.3%)	1 (2.1%)	18 (1.7%)
Currently smoking, n (%)	3 (0.6%)	7 (1.9%)	1 (0.5%)	1 (2.1%)	12 (1.1%)
Alcoholic drinks per week, mean (SD)	0.1 (0.5)	0.2 (1.2)	0.0 (0.0)	0.2 (1.1)	0.1 (0.8)
Caffeinated drinks per week, mean (SD)	0.9 (2.4)	4.2 (5.6)	0.1 (0.7)	1.6 (3.6)	1.7 (3.9)
Patients with current comorbidities^a, n (%)
Hypertension	159 (34.8%)	216 (57.3%)	84 (37.3%)	32 (66.7%)	491 (44.4%)
Type 2 diabetes mellitus	46 (10.1%)	35 (9.5%)	28 (12.7%)	8 (16.7%)	117 (10.7%)
Rheumatoid arthritis or other rheumatologic conditions	28 (6.2%)	24 (6.5%)	20 (9.1%)	7 (14.6%)	79 (7.2%)
Concomitant medications^b, n (%)
Antihypertensives	117 (24.7%)	152 (40.1%)	31 (13.2%)	29 (60.4%)	329 (29.0%)
Insulins/oral hypoglycemics	30 (6.3%)	47 (12.4%)	11 (4.7%)	5 (10.4%)	93 (8.2%)
Glucocorticoids^c	9 (5.2%)	6 (2.5%)	3 (5.9%)	2 (5.6%)	20 (4.0%)

Notes: Percentages were calculated using n, the number of valid (not missing or unknown) responses for each item. ^aThe three most frequent comorbidities in the overall East Asian cohort are listed; ^bConcomitant medications related to the risk of osteoporosis and falls taken by ≥4% of all patients in the overall East Asian subregional cohort at baseline. Other medications included oral anticoagulants/heparin (3.9% of all patients), benzodiazepines (3.0%), antidepressants (3.0%), thyroid hormones (1.8%), antiarrhythmics (1.8%), and anticonvulsants (1.3%); ^cPrednisone daily equivalent dose ≥7.5 mg for ≥3 months.

Abbreviations: N, total number of patients available; n, number of patients with valid (non-missing or unknown) values.

Table 3 Previous Use of Osteoporosis and Analgesic Medications

Characteristic	Taiwan (N=474)	South Korea (N=379)	China (N=235)	Hong Kong (N=48)	All Patients East Asian Subregion (N=1136)
Past use of osteoporosis medication^a, n (%)	370 (78.1%)	162 (42.7%)	140 (59.6%)	47 (97.9%)	719 (63.3%)
Number of previous osteoporosis medications, n (%)
0	104 (21.9%)	217 (57.3%)	95 (40.4%)	1 (2.1%)	417 (36.7%)
1	214 (45.1%)	131 (34.6%)	33 (14.0%)	5 (10.4%)	383 (33.7%)
2	107 (22.6%)	26 (6.9%)	62 (26.4%)	14 (29.2%)	209 (18.4%)
3	39 (8.2%)	3 (0.8%)	32 (13.6%)	21 (43.8%)	95 (8.4%)
4	8 (1.7%)	0 (0.0%)	13 (5.5%)	6 (12.5%)	27 (2.4%)
5 or more	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (2.1%)	1 (0.1%)
Previous pharmacotherapy for osteoporosis^b, n (%)
Alendronate	122 (25.7%)	26 (6.9%)	33 (14.0%)	30 (62.5%)	211 (18.6%)
Ibandronate	31 (6.5%)	25 (6.6%)	4 (1.7%)	2 (4.2%)	62 (5.5%)
Risedronate	0 (0.0%)	14 (3.7%)	8 (3.4%)	0 (0.0%)	22 (1.9%)
Zoledronate	35 (7.4%)	3 (0.8%)	12 (5.1%)	3 (6.3%)	53 (4.7%)
Other bisphosphonates	2 (0.4%)	5 (1.3%)	2 (0.9%)	1 (2.1%)	10 (0.9%)
Any one or more bisphosphonates	180 (38.0%)	72 (19.0%)	54 (23.0%)	33 (68.8%)	339 (29.8%)
Calcitonin	3 (0.6%)	1 (0.3%)	42 (17.9%)	4 (8.3%)	50 (4.4%)
Calcium only	160 (33.8%)	53 (14.0%)	54 (23.0%)	38 (79.2%)	305 (26.8%)
Denosumab	106 (22.4%)	1 (0.3%)	0 (0.0%)	4 (8.3%)	111 (9.8%)
Estrogen therapy	3 (0.6%)	3 (0.8%)	0 (0.0%)	0 (0.0%)	6 (0.5%)
Raloxifene	66 (13.9%)	9 (2.4%)	0 (0.0%)	0 (0.0%)	75 (6.6%)
Other SERMs	0 (0.0%)	7 (1.8%)	0 (0.0%)	0 (0.0%)	7 (0.6%)
Strontium ranelate	5 (1.1%)	0 (0.0%)	0 (0.0%)	1 (2.1%)	6 (0.5%)
Vitamin D only	41 (8.6%)	8 (2.1%)	112 (47.7%)	42 (87.5%)	203 (17.9%)
Use of ≥ 1 back pain medication over the past 24 hrs, n (%)	210 (44.3%)	167 (44.1%)	51 (21.7%)	17 (35.4%)	445 (39.2%)
Specific back pain medications, n (%)
NSAIDs	106 (22.4%)	62 (16.4%)	44 (18.7%)	3 (6.3%)	215 (18.9%)
Paracetamol	27 (5.7%)	26 (6.9%)	1 (0.4%)	14 (29.2%)	68 (6.0%)
Opioids	20 (4.2%)	88 (23.2%)	4 (1.7%)	6 (12.5%)	118 (10.4%)
Paracetamol and opioid combination	98 (20.7%)	65 (17.2%)	0 (0.0%)	0 (0.0%)	163 (14.3%)

Notes: Percentages were calculated using n, the number of valid (not missing or unknown) responses for each item. ^aThis includes ongoing medications as well as those stopped before baseline; ^bPrior osteoporosis medications taken by >0.5% of all patients in the overall East Asian subregional cohort.

Abbreviations: N, total number of patients available; n, number of patients with valid (non-missing or unknown) values; NSAIDs, nonsteroidal anti-inflammatory drugs; SERMs, selective estrogen receptor modulators.

Table 4 Health-Related Quality of Life Scores at Baseline

Characteristic	Taiwan (N=474)	South Korea (N=379)	China (N=235)	Hong Kong (N=48)	All Patients East Asian Subregion (N=1136)
EQ-5D-5L – VAS score^a
Median (Q1, Q3)	60.0 (50.0, 75.0)	60.0 (45.0, 80.0)	60.0 (50.0, 70.0)	70.0 (50.0, 80.0)	60.0 (50.0, 75.0)
Mean (SD)	61.0 (17.8)	57.5 (25.3)	59.8 (17.4)	64.1 (21.4)	59.7 (20.8)
EQ-5D-5L – Utility Total Score
Median (Q1, Q3)	0.6 (0.3, 0.7)	0.3 (0.0, 0.6)	0.6 (0.3, 0.7)	0.6 (0.3, 0.8)	0.5 (0.2, 0.7)
Mean (SD)	0.5 (0.4)	0.2 (0.4)	0.5 (0.3)	0.6 (0.3)	0.4 (0.4)
EQ-5D-5L severe/extreme problems^b, n (%)
Mobility	117 (25.1%)	215 (57.2%)	63 (27.4%)	10 (20.8%)	405 (36.1%)
Self-care	88 (18.8%)	182 (48.4%)	42 (18.3%)	10 (20.8%)	322 (28.7%)
Usual activities	111 (23.8%)	233 (62.0%)	60 (26.0%)	8 (16.7%)	412 (36.7%)
Pain/discomfort	89 (19.1%)	163 (43.4%)	47 (20.3%)	6 (12.5%)	305 (27.2%)
Anxiety/depression	62 (13.2%)	66 (17.6%)	16 (7.0%)	4 (8.3%)	148 (13.2%)
Back Pain Numeric Rating Scale^c
Worst pain in the last 24 hrs, median (Q1, Q3)	5.0 (3.0, 8.0)	6.0 (3.0, 8.0)	5.0 (3.0, 8.0)	5.0 (0.0, 8.0)	5.0 (3.0, 8.0)
Average pain in the last 24 hrs, median (Q1, Q3)	4.0 (2.0, 6.0)	4.0 (1.0, 6.0)	3.0 (2.0, 5.0)	3.5 (0.0, 5.0)	4.0 (2.0, 6.0)
Worst pain in the last 24 hrs, mean (SD)	5.3 (3.0)	5.3 (3.4)	5.0 (3.2)	4.4 (3.8)	5.2 (3.2)
Average pain in the last 24 hrs, mean (SD)	4.0 (2.6)	3.9 (3.1)	3.7 (2.6)	3.6 (3.1)	3.9 (2.8)

Notes: Percentages were calculated using n, the number of valid (not missing or unknown) responses for each item. ^aA 100-mm visual analog scale was used to indicate perceived overall health status (0=the worst health you can imagine; 100=the best health you can imagine); ^bFor the “mobility,” “self-care,” and “usual activities” domains, extreme problems refer to inability to move, inability to take care of self, and inability to perform usual activities, respectively; ^cBack pain was self-assessed by patients on a rating scale of 0 to 10 (0=no back pain; 10=worst possible back pain).

Abbreviations: N, total number of patients; n, number of patients with valid (non-missing or unknown) values; Q1, 1st quartile; Q3, 3rd quartile; VAS, Visual Analog Scale.