Alendronate versus Raloxifene for Postmenopausal Women: A Meta-Analysis of Seven Head-to-Head Randomized Controlled Trials

Table 1

Characteristics of the included studies.

Author/year/area	Design	Sample size (Aln/Rlx)	Aln group age (Mean ± SD); BMI (kg/m^2); BMD (g/cm^2 or T-score)	Rlx group age (Mean ± SD); BMI (kg/m^2); BMD (g/cm^2 or T-score)	Intervention	Duration (months)	Cofactors	Outcome measurement	Loss to followup (Aln/Rlx)	Industrial funding
Iwamoto et al./2008/Japan [15]	Open-labeled; RCT	122 (61/61)	70.3 (7.6); 21.9 (2.6); LS: 0.620±0.084	68.5 (7.2); 21.7 (2.5); LS: 0.647±0.070	Aln 5 mg/day; or Rlx 60 mg/day; for 12 months	12	800 mg Ca	(1) Change in BMD in LS measured by DXA at baseline, 6 mo and 12 mo.; (2) Changes in serum calcium and phosphorus and bone turnover markers at 1 wk, 6 mo and 12 mo.; (3) Changes in the components of the serum lipid profile; (4) AEs	18%/14.8%; 11/9	None
Johnell et al./2002/Australia^# [16]	Multicenter; double blinded; RCT	331 (83/81)	63.7±6.0; 24.8±3.8; LS: 0.78±0.14	63.4±6.3; 24.8±3.8; LS: 0.77±0.12	Aln 10 mg/day; or Rlx 60 mg/day; or both for 12 months	12	500 mg Ca plus 400–600 U vit D	(1) Change in BMD in LS, FN measured by DXA at baseline, 6 mo and 12 mo.; (2) Change in serum OC, ALP, urinary NTx/Cr at 6 mo and 12 mo.; (3) AEs	Total: 17.2%/57	Rlx (Eli Lilly; & Co.)
Luckey et al./2004/USA [17]	Multicenter; double blinded; RCT	456 (223/233)	63.8±9.9; 25.3±5.2; LS: −2.43±0.78	64.7±9.8; 25.3±4.8; LS: −2.5±0.69	Aln 70 mg/week; or Rlx 60 mg/day; for 12 months	12	500 mg Ca plus 200 U vit D	(1) Change in BMD in TH, LS, and FN measured by DXA at baseline, 6, and 12 mo.; (2) Change in serum ALP, urinary NTx/Cr at 6 mo and 12 mo.; (3) AEs	19.7%/17.2%; 179/173	Aln (Meck; & Co.)
Muscoso et al./2004/Italy [18]	Open-labeled; RCT	2000 (1000/100)	71±8; NR; NR	64±3; NR; NR	Aln 10 mg/day; or Rlx 60 mg/day; for 24 months	24	1000 mg Ca plus 800 U vit D	(1) Change in BMD in LS measured by DXA at baseline, 12, and 24 mo.; (2) Fracture assessment	0	None
Recker et al./2007/USA [19]	Multicenter; double blinded; RCT	1423 (716/707)	65.7±7.8; 24.5±4.1; LS: 0.82±0.13; −2.34±1.03	65.5±7.7; 24.8±4.2; LS: 0.82±0.13; −2.32±0.99	Aln 10 mg/day; or Rlx 60 mg/day; for 12 months	24	500 mg Ca plus 400 U vit D	(1) Fracture assessment; (2) Change in BMD in TH, LS, and FN measured by DXA at baseline and 24 mo.; (3) AEs	2.2%/1.7%; 16/12	Rlx (Eli Lilly; & Co.)
Sambrook et al./2004/USA [20]	Multicenter; double blinded; RCT	487 (246/241)	61.5±8.2; 25.5±3.7; LS: −2.89±0.78	61.8±7.7; 25.3±3.9; LS: −2.86±0.76	Aln 70 mg/week; or Rlx 60 mg/day; for 12 months	12	Ca plus vit D^$	(1) Change in BMD in LS, FN, TH, and HT measured by DXA at baseline, 6 mo and 12 mo.; (2) Change in serum ALP, urinary NTx/Cr at 6 mo and 12 mo.; (3) AEs	12%/14%; 30/33	Aln (Meck; & Co.)
Sanad et al./2011/Egypt [21]	RCT	135 (44/46)	61.7±4.3; 25.8±3.1; LS: 0.75±0.05	62.5±3.9; 26.5±2.9; LS: 0.73±0.06	Aln 70 mg/week; or Rlx 60 mg/day; or both for 12 months	12	1500 mg Ca plus 400 U vit D	(1) Change in BMD in TH, LS, and FN measured by DXA at baseline, 6, and 12 mo.; (2) Changes in serum ALP, NTx/Cr at 1 wk, 6 mo, and 12 mo.; (3) Changes in the components of the serum lipid profile; (4) AEs	23.9%/29.5%; 13/11	None

Aln: alendronate; Rlx: raloxifene; SD: standard deviation; BMI: body mass index; BMD: bone mineral density; RCT: radomized controlled trials; LS: lumbar spine; mo: months; NR: not reported; Ca: calcium; Vit D: vitamine D; DXA: dual-energy X-ray absorptiometry; TH: total hip; FN: femoral neck; NTx/Cr: urinary cross-linked N-telopeptide of type 1 collagen corrected to creatinine (Cr) excretion; ALP: serum bone-specific alkaline phosphatase; AEs: adverse events.
^#The fracure data in Johnell's study were not reported in his original article but were cited by Recker's papers and then were extracted and pooled.
^$The dose of calcium or vitamine D was not clearly stated.