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Oral calcitonin tablets safe, effective in phase 3 ORACAL trial
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ASBMR 2011
Postmenopausal women with osteoporosis assigned to treatment with oral recombinant salmon calcitonin experienced improvements in lumbar spine bone mineral density at 48 weeks that were superior to improvements of women assigned to nasal salmon calcitonin and placebo, according to new phase 3 results.
The multinational, randomized, double blind, double dummy, placebo-controlled ORACAL trial compared 200 mcg bedtime oral recombinant salmon calcitonin (Ostora, Tarsa Therapeutics) with 200 IU nasal synthetic salmon calcitonin and placebo. The trial enrolled 565 postmenopausal women in six countries (mean age, 66.5 years; mean lumbar spine T-score, -2.84). The women also received 1,000 mg calcium and 800 IU daily vitamin D. DXA scans were obtained at baseline, 24 weeks and 48 weeks.
"The efficacy data were robust and internally consistent," the researchers said. In a modified intent-to-treat population, women assigned to oral calcitonin (n=189) had a 1.53% increase in lumbar spine BMD (P<.001) compared with a 0.76% increase in women assigned nasal calcitonin (n=140; P=.014) and 0.47% increase in women assigned placebo (n=82).
Results from a per-protocol population of women also showed consistent changes in biomarkers of bone resorption. Fasting serum C-terminal telopeptide at 48 weeks' examination decreased by 29.9% in the oral calcitonin arm, 11.4% in the nasal calcitonin arm and 11.8% in the placebo arm (oral vs. nasal, P<.001).
Tolerability was similar between the oral, nasal and placebo groups, according to the researchers. Gastrointestinal-related issues were the most commonly reported adverse events and were generally mild or moderate in severity.
"These are encouraging results that may be of particular relevance for the women with osteoporosis who are reluctant to take or unable to tolerate currently available treatments. Potential safety issues with current drug therapies, while rare, have led some osteoporosis patients to discontinue therapy or avoid beginning treatment. Calcitonin has a long history of safety for postmenopausal osteoporosis treatment, and potential availability of this once-daily oral formulation could make it a useful new option for osteoporosis patients and their physicians," Neil Binkley, MD, associate professor of endocrinology and geriatrics, University of Wisconsin School of Medicine and Public Health, said in a press release.
Earlier in 2011, Tarsa Therapeutics reported efficacy and safety results from the ORACAL trial. The recent data reported show that the drug achieved all efficacy endpoints in the trial and indicate that the safety profile did not substantially differ from nasal calcitonin or placebo.
Calcitonin is approved for the treatment of postmenopausal osteoporosis, but is currently available only in intranasal and injectable forms.
For more information:
- Binkley N. Concurrent oral session 23. Abstract #1134. Presented at: the American Society for Bone and Mineral Research 2011 Annual Meeting; Sept. 16-20, 2011; San Diego.
Disclosure: Dr. Binkley has received research grants from Tarsa Therapeutics.
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