A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women
Summary
The purpose of this study is to compare the effectiveness and tolerability of two medications, calcitonin nasal spray and a tablet containing calcitonin, in postmenopausal women with osteoporosis. Osteoporosis is the term used to describe a large group of diseases, which are characterized by loss of bone density, which makes the bones weaker. Osteoporosis often occurs in postmenopausal women. Calcitonin is a hormone found in the human body. Together with other substances, it regulates the concentration of calcium in the blood and inhibits the natural resorption of bone. Both medications in this study contain salmon calcitonin (sCT), because this form of calcitonin is more active than human calcitonin when used as a medicine. The calcitonin Nasal Spray used in this study is registered and available to doctors in United States for the treatment of osteoporosis. The medication being tested in this study is an oral tablet form of salmon calcitonin.
Timeline
- Start
- 2009-06
- Primary completion
- 2011-02
- Completion
- 2011-02
Outcome
Met primary endpoint
registry analysis (non-inferiority or equivalence test); Oral Calcitonin vs Nasal Calcitonin vs Placebo; p = 0.002; Mean Difference (Net) 0.77 (95% CI 0.08 to 1.45) NCT00959764 ↗
paper Women randomized to oral rsCT had a mean ± SD percent increase from baseline in lumbar spine bone mineral density (BMD) (1.5% ± 3.2%) that was greater than those randomized to ssCT nasal spray (0.78% ± 2.9%) or placebo (0.5% ± 3.2%). PMID 22437792 ↗
release “Phase III ORACAL trial showing that OSTORA achieved all of the trial’s efficacy endpoints” tarsatherapeutics.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | salmon calcitonin | Unknown | 0.2 mg | Oral |
| Subject | salmon calcitonin | Unknown | 200 iu | Oral |