Table 4. Randomized Controlled Trials of Alendronate with Fracture Outcomes
| Author |
Duration (years) |
Age (years) |
Population |
Exclusion Criteria1 |
Participants Lost to Followup |
Quality Rating2 |
| Adami, 1995 (103) |
2 |
48-76 |
9 Italian Centers, T-score <-2 (0.67g/cm2); 5% vertebral fractures |
Narrow |
32/211 (15.2%) |
Fair to Good |
| Black, 1996 (104) |
3 |
55-81 |
11 U.S. cities, BMD <0.68 g/cm2; no previous vertebral fractures |
Broad (medical illness, dyspepsia, etc.) |
81/2,027 (4%) |
Good |
| Bone, 1997 (105) |
2 |
>60 |
15 U.S. sites, BMD <0.84 g/cm2; average 20 yrs since menopause; 30.7% vertebral fractures |
Broad (medical illness, NSAIDs, GI drugs) |
19/359 (5.3%) |
Fair to Good |
| Chesnut, 1995 (106) |
2 |
42-75 (avg. 63) |
7 centers, spine BMD <0.88, average hip BMD 0.7; ≥5 years since menopause |
Broad |
26/157 (16.6%) |
Fair |
| Cummings, 1998 (107) |
4 |
55-81 |
11 U.S. cities, BMD <0.68 g/cm2 (ave. 0.59); no previous vertebral fractures |
Broad (medical illness, dyspepsia) |
179/4,432 (4%) |
Good |
| Greenspan, 1998 (108) |
2.5 |
>65 |
1 Boston center, no BMD entry criteria |
Narrow ("good health") |
33/120 (27.5%) |
Fair |
| Hosking, 1998 (109) |
4 |
45-59 |
4 centers, BMD >0.8 g/cm2; <10% prevalent vertebral fractures |
Narrow ("good health") |
287/1,499 (19.1%) |
Fair |
| Liberman, 1995 (110) |
3 |
45-80 |
2 multicenter trials, T-score <-2.5; 21% prevalent vertebral fractures |
Narrow ("good health") |
170/994 (17.1%) |
Good |
| McClung, 1998 (111) |
3 |
40-59 |
15 centers, T-score <-2; 6-36 months since menopause; no previous vertebral fractures |
Narrow ("good health," estrogen use) |
31% at 3 years |
Fair |
| Pols, 1999 (112) |
1 |
40-82 |
153 centers, T-score <-2.8 |
Narrow ("good health") |
211/1,908 (11.1%) |
Fair |
1In general, "narrow" criteria excluded estrogen users and patients with illnesses affecting bone metabolism.
2Based on criteria developed by the U.S. Preventive Services Task Force (22).
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