Table 1.
Results of literature review about efficacy of antiosteoporotic drugs.
| First author and year | Study design | Study population | Outcome | N | Results | |||
|---|---|---|---|---|---|---|---|---|
| Vertebral fractures | Nonvertebral fractures | Hip/femoral fractures | ||||||
| Alendronate | Wells et al. 2008 [49] | Cochrane review | Postmenopausal women | Osteoporotic fractures after ≥1 year of follow-up | 12,068 (4,576 in primary prevention) | Reduction of 45% (33–55%) (primary prevention) |
Reduction of 16% (6–26%) | Reduction of 40% (7–60%) of femoral fractures and of 21% (n.s.) of hip fractures |
| Black et al. 2000 (FIT) [50] | RCT | Women in menopause since at least 2 years | Fractures after 3/4 years of treatment | 6,459 | Single vertebral fractures: reduction of 47% (32–59%). Multiple vertebral fractures: reduction of 90% (78–95%) | Reduction of 19% (n.s.) | Reduction of 51% (1–77%) | |
| Cummings et al. 1998 (FIT) [51] | RCT | Women in menopause since at least 2 years | Fractures after 4 years of treatment | 4,432 | One or more vertebral fractures: reduction of 44% (39–80%) Two or more vertebral fractures: reduction of 60% (n.s.) |
Reduction of 12% (n.s.) | Reduction of 21% (n.s.) | |
| Black et al. 1996 (FIT) [52] | RCT | Women in menopause since at least 2 years | Fractures after 24 and 36 months of treatment | 2,027 | One or more morphometric vertebral fractures: reduction of 47% (32–59%). Two or more morphometric vertebral fractures: reduction of 90% (78–95%) |
Reduction of 20% (n.s.) | Reduction of 48% of hip fractures (13–69%) | |
| Liberman et al. 1995 [53] | RCT | Women in menopause since at least 5 years | Osteoporotic fractures after 3 years of treatment | 881 | Reduction of 48% (5–72%) | — | — | |
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| Risedronate | Wells et al. 2008 [54] | Cochrane review | Postmenopausal women | Osteoporotic fractures | 14,049 | Reduction of 27% (23–49%) (primary and secondary prevention) |
Reduction of 20% (10–28%) (primary and secondary prevention) | — |
| Harris et al. 1999 (VERT) [55] | RCT | Women in menopause since at least 5 years, aged <85 years and with ≥2 vertebral fractures | Osteoporotic fractures after 1 and 3 years of treatment | 2,458 | First year of treatment: reduction of 46% (9–68%) with risedronate 2,5 mg and of 65% (38–81%) with risedronate 5 mg. After 3 years of treatment: reduction of 41% (18–57%) |
After 3 years of treatment: reduction of 40% (6–61%) | — | |
| Reginster et al. 2000 (VERT) [56] | RCT | Women in menopause since at least 5 years, aged <85 years and with ≥2 vertebral fractures | Osteoporotic fractures after 3 years of treatment | 1,226 | Reduction of 49% (27–64%) | Reduction of 33% (n.s.) | ||
| McClung et al. 2001 (HIP) [57] | RCT | Postmenopausal women aged 70–79 years | Osteoporotic fractures after 3 years of treatment | 5,445 | — | — | Reduction of 40% (10–60%) | |
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| ||||||||
| Ibandronate | Harris et al. 2008 [58] | Meta-analysis | BONE, IV Fracture Prevention, MOBILE, and DIVA studies | Nonvertebral and clinical fractures | 8,710 | — | Reduction of 29.9% | — |
| Chesnut III et al. 2004 (BONE) [59] | RCT | Women in menopause since at least 5 years, aged 55–80 years, with 1–4 previous vertebral fractures and a T-score of −2.0 to −5.0 in at least one vertebral site | New morphometric vertebral fractures at 3 years of treatment | 2,946 | Reduction of 62% (41–75%) for daily dose and of 50% (26–66%) for intermittent dose | Nonsignificant results | — | |
|
| ||||||||
| Zolendronate | Black et al. 2007 (HORIZON) [60] | RCT | Women aged 65–89 years with a T-score ≤ 2,5 (with or without vertebral fractures) or T-score ≤ 1,5 and at least 2 vertebral fractures | Osteoporotic fractures after 3 years of treatment | 7,765 | Reduction of 70% (62–76%) | Reduction of 25% (13–36%) | Reduction of 41% (17–58%) |
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| ||||||||
| Strontium ranelate | Meunier et al. 2004 (SOTI) [61] | RCT | Women ≥ 50 years with ≥1 osteoporotic vertebral fractures | Vertebral fractures after 3 years of treatment | 1,649 | Reduction of 49% (26–64%) after 1 year and of 41% (27–52%) after 3 years | — | — |
| Reginster et al. 2005 (TROPOS) [62] | RCT | Women ≥ 74 years (or aged 70–74 with at least another risk factor for fracture) | Vertebral and nonvertebral fractures | 5,091 | Reduction of 45% (23–61%) after 1 year and of 39% (27–49%) after 3 years |
Reduction of 16% (0.5–29.8%). Reduction of 19% of major fractures (2–34%) |
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| PTH 1-34 and 1-84 |
Vestergaard et al. 2007 [63] | Meta-analysis | Postmenopausal women | Osteoporotic fractures | 4,155 | Reduction of 63% (52–72%) | Reduction of 38% (18–54%) | — |
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| ||||||||
| PTH 1-34 | Neer et al. 2001 (FPT) [64] | RCT | Women in menopause since at least 5 years with ≥2 mild vertebral fractures or 1 moderate vertebral fracture | Osteoporotic fractures after 2 years of treatment | 1,637 | PTH 1-34, 20 µg/die: reduction of 65% (45–78%). PTH 1-34, 40 µg/die: reduction of 69% (50–81%) | PTH 1-34, 20 µg/die: reduction of 53% (12–75%). PTH 1-34, 40 µg/die: reduction of 54% (14–75%) | — |
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| PTH 1-84 | Greenspan et al. 2007 (TOP) [65] | RCT | Women aged 45–54 years with T-score ≤ −3 and no previous fractures or T-score ≤ −2,5 and 1–4 previous fractures, and women ≥ 55 years with T-score ≤−2.5 and no previous fractures or T-score ≤ −2 and 1–4 previous fractures | New osteoporotic fractures or worsening of previous osteoporotic fractures after 18 months of treatment | 2,532 | Reduction of 58% (28–76%) | Nonsignificant results | — |
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| ||||||||
| SERM | Cranney et al. 2002 [66] | Meta-analysis | Postmenopausal women | Vertebral and non-vertebral fracture | 7,848 | Reduction of 40% (30–50%) with a dosage ≥60 mg/die | Nonsignificant results | — |
| Ettinger et al. 1999 (MORE) [67] | RCT | Women in menopause since at least 2 years, aged < 80 years with a T-score ≤ −2,5 or previous vertebral fractures | Vertebral and non-vertebral fractures | 7,705 | Reduction of 30% (20–50%) with 60 mg/die and 50% (30–60%) with 120 mg/die | Non significant results | — | |
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| ||||||||
| TOS | Torgerson and Bell-Syer 2001 [68] | Meta-analysis | Postmenopausal women | Vertebral fractures | 6,723 | Reduction of 33% (2–55%). Reduction of 53% (11–75%) in women with previous osteoporosis and of 37% (4–59%) in women > 60 years | — | — |
| Cauley et al. 2003 (WHI) [69] | RCT | Women aged 50–79 years with a BMD ≥ 3 than age-specific mean | Vertebral, hip, and other osteoporotic fractures | 16,608 | — | Reduction of 25% (17–32%) | Reduction of 33% (4–53%) | |
n.s.: not significant; BONE: oral iBandronate Osteoporosis vertebral fracture trial in North America and Europe; FIT: Fracture Intervention Trial; FPT: Fracture Prevention Trial; HIP: Hip Intervention Program; HORIZON: Health Outcomes and Reduced Incidence with Zoledronic Acid ONce yearly; MORE: Multiple Outcomes of Raloxifene Evaluation; SOTI: Spinal Osteoporosis Therapeutic Intervention; TROPOS: TReatment Of Peripheral OSteoporosis; TOP: Treatment of Osteoporosis with Parathyroid hormone; VERT: Vertebral Efficacy with Risedronate Therapy; WHI: Women's Health Initiative.