Skip to main content
. 2015 Nov 24;5(11):e008554. doi: 10.1136/bmjopen-2015-008554

Table 3.

Study validity and outcomes (bone mineral density and fractures) in adults

(a) RCTs of inhaled corticosteroids—adults
Source Sequence generation Allocation concealment Blinding of participants and personnel AE monitoring Drug (n) Mean change in BMD g/cm2 Dis-continued, number (%) Loss to follow-up, number (%)
Kemp et al16 Random code with blinded labels Adequate Adequate DEXA scan every 6 months at lumbar spine (L1-L4). analysed by central osteoporosis research facility for quality assurance
Adjusted for baseline value, investigator, sex, age
FP 88 µg bd At week 104
1) Lumbar spine: 0.008, SE 0.006
2) Proximal femur: −0.009, SE 0.009
17 (31) 6 (11)
FP 440 µg bd At week 104
1) lumbar spine: -0.003, SE 0.008
2) Proximal femur: −-0.020, SE 0.009
18 (35) 7 (14)
Placebo bd At week 104
1) Lumbar spine: 0.001, SE 0.005
2) Proximal femur: −0.007, SE 0.007
10 (19) 4 (7)
Li et al17 Unclear Unclear Adequate DEXA at L1-L4 of lumbar spine. Measured at screening and 6-month intervals FP At week 104, lumbar spine: −0.006, SE 0.008 9 (28) 2 (6)
Placebo At week 104, lumbar spine: −0.007, SE 0.010 8 (25) 7 (22)
Maspero et al18 Centrally administered through interactive voice response system Adequate Adequate DEXA at L1-L4 of lumbar spine. Follow-up at 26 and 52 weeks Mometasone 400 µg 1) Lumbar spine: 0.0092) Femur: 0.004 34 (25) 5 (3)
Mometasone 200 µg daily 1) Lumbar spine: 0.0082) Proximal femur: 0.004 35 (25) 7 (4)
FP 250 µg bd 1) Lumbar spine: 0.0122) Femur: −-0.005 38 (26) 4 (3)
Combined estimate for all ICS users 1) Lumbar spine: 0.0092) Femur: 0.0008 107 (25) 16 (4)
Montelukast 10 mg daily 1) Lumbar spine: 0.0132) Femur: −0.002 31 (22) 3 (3)

AE, adverse event; bd, two times a day; DEXA, dual-energy X-ray absorptiometry; FP, fluticasone propionate; ICS, inhaled corticosteroids; RCT, randomised controlled trial.