Objective

Inclusion Criteria

Exclusion Criteria

Result

Author’s

Conclusion

BMD

BTM

Fractures

Patients who previously had 3 years of yearly ZOL infusions were then re-randomized to either continuing ZOL or receiving placebo infusions for 3 more years

・ Men and women 50 years of age or older were eligible for inclusion within 90 days after surgical repair of a hip fracture sustained with minimal trauma (i.e., a fall from standing height or a lower height) ・ Ambulatory before the hip fracture and having both legs

・ Previous hypersensitivity to a bisphosphonate, ・ Potential for pregnancy,

・ CrCl of <30 ml/min,

・Corrected serum calcium level of more than 11.0 mg/dl (2.8 mmol/L) or <8.0 mg/dl (2.0 mmol/L),

・ Active cancer, metabolic bone disease other than osteoporosis, and a life expectancy of less than 6 months in the investigator’s judgment

ZOL mean FN BMD change of 0.24% vs. −0.80% in PBO (mean difference 1.04%, P < 0.001);

ZOL mean LS BMD increased by 3.20 vs. 1.18% for PBO (mean difference 2.03%, P < 0.01);

At all sites, BMD after 6 y of ZOL therapy was significantly (P < 0.05) greater than for those given ZOL for 3 years and then PBO for 3 years (except distal radius)

S-PINP rose slightly in both the ZOL (19%) and PBO (33%) groups (P < 0.001), but remained substantially below pretreatment levels

Significant difference between groups for morphometric vertebral fractures (3.0% with ZOL, 6.2% with PBO; OR = 0.51, 95% CI = 0.26 - 0.95);

No significant differences between groups for all clinical fractures (HR = 1.04, 95% CI = 0.71 - 1.54);

No significant difference between groups for nonvertebral fractures (8.2% with ZOL, 7.6% with PBO; HR = 0.99, 95% CI = 0.26 - 0.95);

No significant difference between groups for clinical vertebral fractures (HR = 1.81, 95% CI = 0.53 - 6.2, NS)

The group that continued ZOL for a total of 6 years had a significantly lower incidence of radiographically adjudicated vertebral fracture