The Prevention of Postmenopausal Osteoporotic Fractures: Results of the Health Technology Assessment of a New Antiosteoporotic Drug

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%)	—	—
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%)
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%)
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%)
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%)	—
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%)	—
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	—
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	—
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.