A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis
Summary
The primary purpose of this study was to evaluate the efficacy of oral calcitonin (rsCT)tablets in the prevention of bone loss in postmenopausal women with lower bone mineral density at increased risk of fracture. The secondary purpose of this study was to determine if there is any food effect by comparing the efficacy and safety of oral calcitonin tablets administered at dinner or at bedtime.
Timeline
- Start
- 2011-01
- Primary completion
- 2012-05
- Completion
- 2012-07
Outcome
Met primary endpoint
registry analysis (superiority or other test); Oral Calcitonin Tablets vs Oral Placebo Tablets; p = 0.0265; Mixed Models Analysis NCT01292187 ↗
release “Phase II trial of its oral recombinant salmon calcitonin in the prevention of postmenopausal osteoporosis was successfully concluded and yielded statistically significant, clinically relevant improvements” tarsatherapeutics.com ↗
release “Tarsa’s oral calcitonin was superior to placebo in increasing BMD at the lumbar spine in this population” tarsatherapeutics.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcitonin | Protein / enzyme biologic | — | Oral |