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

Status:	Archived
Conditions:	Osteoporosis, Postmenopausal Syndrome
Therapuetic Areas:	Endocrinology, Rheumatology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	January 2011
End Date:	February 2012

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

The primary purpose of this study is to evaluate the efficacy of rsCT oral 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 is to compare the safety and
tolerability of rsCT oral tablets to placebo and to compare the safety and tolerability of
rsCT oral tablets administered at dinner, compared to administration at bedtime.

Calcitonin (CT) is a 32 amino-acid peptide hormone secreted by the parafollicular cells (C
cells) of the thyroid gland in mammals. It inhibits bone resorption and is regulated by
circulating concentrations of calcium. Salmon calcitonin (sCT) is more potent than the human
form. Synthetic salmon calcitonin (ssCT) is currently available in the US for subcutaneous,
intramuscular, intravenous, and nasal administration for treatment of Paget's disease,
hypercalcemia, and osteoporosis. The identical r-DNA version of sCT is available in the US
as a nasal spray for the treatment of postmenopausal osteoporosis. It is characterized as
an anti-resorptive agent. Side-effects of sCT are minimal apart from nausea and vomiting,
and those are usually resolved with continued dosing. The use of calcitonin is limited by
the currently available routes of administration (injections and nasal spray). Tarsa
Therapeutics, Inc. is developing oral recombinant salmon calcitonin for the treatment of
postmenopausal osteoporosis.

We found this trial at

sites

University of Pittsburgh Medical Center

200 Lothrop St
Pittsburgh, Pennsylvania 15213