The 10-year efficacy and safety data for FOSAMAX have been accepted for publication in an upcoming issue of the New England Journal of Medicine! These landmark findings represent the longest study of a nonhormonal osteoporosis therapy conducted to date. The data were pooled from two identically designed, concurrent, three-year, multicenter, double-blind, randomized, placebo-controlled phase 3 studies that were extended for a total of 10 years. Authored by Henry G. Bone et al, this report presents the results from the 247 postmenopausal women with osteoporosis who participated in all three study extensions.

Alendronate produces greater effects than raloxifene on bone density and bone turnover in postmenopausal women with low bone density: results of EFFECT (EFficacy of FOSAMAX versus EVISTA Comparison Trial)

This adjusted indirect comparison of the systematic reviews and meta-analyses of the Osteoporosis Methodology and Research Advisory Groups (OMG/ORAG) shows that FOSAMAX was significantly more effective than risedronate, calcitonin, estrogen, etidronate, and raloxifene in reducing the risk of nonvertebral fractures and was significantly more effective than calcitonin in reducing the risk of vertebral fractures. No other significant pair-wise differences were found among any of the active agents. Because head-to-head trials with fracture endpoints are not currently available, adjusted indirect comparisons represent the best and most clinically useful information for comparing the efficacy of different treatments for osteoporosis.

In this paper, the researchers evaluate the validity of the Osteoporosis Self-assessment Tool (OST) and compare it with the Osteoporosis Risk Assessment Instrument (ORAI), the Simple Calculated Osteoporosis Risk Estimation (SCORE), and the Osteoporosis Index of Risk (OSIRIS) in identifying those women who are the most likely to have low BMD and are thus most in need of further diagnostic procedures and treatment. They found that "The OST, based only on age and weight, performed as well as the more complex risk assessment indices (SCORE, ORAI, and OSIRIS) in identifying women at low risk of osteoporosis who would not need DXA testing. Avoiding unnecessary testing among low risk patients can substantially reduce cost for the community and the patient."

This one-year, double-blind, double-placebo study compared FOSAMAX 10 mg daily and calcitriol 0.5 µg daily for the prevention of bone loss during the first year after cardiac transplantation in 149 patients. The study showed that when compared with patients in an untreated reference group, patients treated with FOSAMAX 10 mg had significantly less bone loss at both the spine and hip, whereas patients treated with calcitriol had significantly less bone loss at the hip only. The authors state that FOSAMAX 10 mg is the more attractive option for preventing bone loss early after cardiac transplantation because of the increased risk for hypercalcemia and hypercalciuria associated with calcitriol use./p>

In this 1-year extension of a 1-year, randomized, double-blind, multicenter study, the Alendronate Once-Weekly Study Group confirmed that FOSAMAX 70 mg Once Weekly is therapeutically equivalent to FOSAMAX 10 mg daily, "providing patients with a more convenient dosing option that may potentially enhance adherence to therapy."

The results of a randomized controlled trial indicate that hormone replacement therapy (HRT) discontinuation resulted in a significant loss in BMD at the lumbar spine. The study also showed that alendronate not only prevents the BMD loss associated with stopping HRT, but also produces significant increases in bone density at the lumbar spine and hip in postmenopausal women who stopped HRT.

Ann Cranney et al conducted a systematic review and meta-analysis of randomized placebo-controlled trials of FOSAMAX in postmenopausal women. The 11 studies included in their analysis had a follow-up of at least 1 year and measured fracture incidence or change in BMD.

In this review, Ann Cranney et al summarize the findings from seven meta-analyses of different treatments for osteoporosis.

In this head-to-head trial that evaluated the residual effect of FOSAMAX, estrogen, or the combination of both on bone mass after discontinuation of therapy, the authors found that rapid bone loss ensued after stopping estrogen but not after stopping FOSAMAX, either alone or combined with estrogen.

HJ Hauselmann and R Rizzoli analyzed data from 41 peer-reviewed published articles that reported on randomized, double-masked, placebo-controlled studies of agents used in the treatment and/or prevention of osteoporotic fractures.

This very important international trial demonstrated that FOSAMAX Once Weekly was significantly more effective than Actonel daily. Study results showed that FOSAMAX Once Weekly reduced bone resorption faster than risedronate and that after 1 year, patients taking FOSAMAX reported 70% greater increases in BMD at the lumbar spine compared with patients on risedronate, and a 3-fold greater increase in total hip BMD.