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.