NCT01292187

A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis

A Randomized, Double-blind, Placebo-controlled Clinical Trial Evaluating the Safety and Efficacy of Oral Recombinant Salmon Calcitonin (rsCT) in the Prevention of Postmenopausal Osteoporosis in Women at Increased Risk of Fracture

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Tarsa Therapeutics, Inc. · Industry
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a randomized, double-blind, placebo-controlled Phase 2 study conducted entirely in the US. The subjects were all post-menopausal women whose 10-year risk of major osteoporotic fracture was assessed using the World Health Organization (WHO) Fracture Risk Assessment Tool (FRAX®) algorithm within the first 3 visits. Eligible, consenting subjects were then enrolled and began a 2- week single-blind placebo run-in phase to determine tolerability. After the run-in phase, continuing subjects were randomized in a 2:1 ratio to receive oral calcitonin or placebo. All subjects took 600 mg calcium citrate and 1000 IU vitamin D once daily with breakfast beginning with the run-in phase. The duration of treatment including the run-in phase was 54 weeks. Bone mineral density (BMD) and C-terminal telopeptide of type 1 collagen (CTx-1) were determined at Baseline and Weeks 28 and 54 after randomization. The % change from baseline in lumbar spine BMD was calculated and compared: active to placebo. The change from baseline in plasma CTx-1 was also calculated and compared likewise. To confirm that there is no effect of meal timing on this product, subjects in both arms were further randomized to take the active or placebo on an empty stomach at bedtime or with the meal at dinnertime.

Conditions

• Osteopenia

Interventions

Type	Name	Description
DRUG	Oral calcitonin at dinnertime	Oral calcitonin at dinnertime.
DRUG	Oral placebo at dinnertime	Oral placebo at dinnertime.
DRUG	Oral calcitonin at bedtime	Oral calcitonin at bedtime
DRUG	Oral placebo at bedtime	Oral placebo at bedtime

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-05-01
• Completion: 2012-07-01
• First posted: 2011-02-09
• Last updated: 2014-09-12
• Results posted: 2014-09-12

Locations

10 sites across 1 country: United States