Alendronate

Comparative Trials Find Oral Alendronate Therapy Superior to Intranasal Calcitonin

Alendronate produced significantly greater increases in bone mineral density (BMD) at the spine and hip than did intranasal calcitonin after 1 year of therapy in the first 2 studies comparing the drugs at recommended osteoporosis treatment doses in postmenopausal women. These findings were presented at the European Symposium on Calcified Tissue in Maastricht and the Endocrine Society Meeting in San Diego.

Maastricht Presentation:
A poster presented at the European Symposium by Dr. Clifford J. Rosen, of The Maine Center for Osteoporosis Research and Education in Bangor, and colleagues, reported on a randomized study of 275 postmenopausal women. Enrolled subjects were >=45 years of age and >=5 years postmenopausal, or >=25 years of age and >=5 years postsurgical menopause. BMD entry criteria included a T-score of >=2 standard deviations below the young normal mean at either the lumbar spine or the femoral neck and >=1 standard deviation below the young normal mean at the other site and not more than 4 standard deviations below the young normal mean at both sites. The women had no history of minimal trauma hip fracture or evidence of prevalent vertebral fractures on spine radiographs.

Patients were randomized to receive alendronate 10 mg or placebo in a blinded fashion or open-label intranasal calcitonin 200 IU. All subjects had a total dietary and supplemental calcium intake of >=1000 mg daily and received a supplement of vitamin D 400 IU daily.

After 12 months, alendronate was shown to increase BMD at the lumbar spine by 3.78%, at the hip trochanter by 3.81%, and at the femoral neck by 1.67%. These increases were statistically significant when compared with both placebo and calcitonin. In addition, the BMD changes in the calcitonin group were similar to those seen with placebo.

Alendronate also significantly reduced values for biochemical markers of bone turnover compared with placebo and calcitonin. As with BMD, calcitonin did not produce reductions in biochemical markers that were different from those produced by placebo.

Both alendronate and calcitonin were well tolerated, the investigators reported.

San Diego Presentation:

In an oral presentation at ENDO '99, Dr. Robert W. Downs, Jr., professor of medicine at Virginia Commonwealth University School of Medicine in Richmond, reported on a separate but similar randomized, placebo-controlled study conducted at 24 centers in the United States and involving 299 postmenopausal women. The entry criteria and treatment groups in this trial were identical to those in the study reported by Dr. Rosen.

Data at 12 months revealed that alendronate produced significantly greater increases in BMD at the lumbar spine and hip trochanter than did calcitonin (4.5% and 4.7% for alendronate, respectively, vs 0.5% for calcitonin and 0% for placebo at both sites). Both drugs were well tolerated and subjects had similar withdrawal rates.

"These results are comparable to results achieved in single, noncomparative trials of these agents," Dr. Downs said.

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