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| Sponsor: | Tarsa Therapeutics, Inc. |
|---|---|
| Information provided by (Responsible Party): | Tarsa Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00959764 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis, Postmenopausal |
Drug: Oral Calcitonin Drug: Nasal Calcitonin Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Multiple Dose, Placebo-Controlled, Parallel Group, 48-Week, Study of Oral Recombinant sCT Compared to Calcitonin Nasal Spray in Postmenopausal Osteoporotic Women |
| Enrollment: | 565 |
| Study Start Date: | June 2009 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Oral Calcitonin |
Drug: Oral Calcitonin
Calcitonin tablets
|
| Active Comparator: Nasal Calcitonin |
Drug: Nasal Calcitonin
Nasal Calcitonin Spray
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo Tablets/Nasal spray
|
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| Rheumatology Associates of N. AL, P.C. | |
| Huntsville, Alabama, United States, 35801 | |
| United States, California | |
| Northern California Institute for Bone Health, Inc. | |
| Oakland, California, United States, 94609 | |
| Desert Medical Advances | |
| Palm Desert, California, United States, 92260 | |
| United States, Maryland | |
| Bethesda Health Research Center/Bone Health Center of Bethesda | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Nebraska | |
| 801 N. 30th Street, Suite 6718 | |
| Omaha, Nebraska, United States, 68131 | |
| United States, New Mexico | |
| New Mexico Clinical Research & Osteoporosis | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
| Bone Mineral Research Center | |
| Mineola, New York, United States, 11501 | |
| United States, Pennsylvania | |
| Altoona Center for Clinical Research | |
| Duncansville, Pennsylvania, United States, 16635 | |
| United States, Wisconsin | |
| University of Wisconsin-Geriatrics & Endocrinology/Medical Sciences Center | |
| Madison, Wisconsin, United States, 53705 | |
| Bulgaria | |
| Diagnostic Consultative Centre, "Sveta Anna" EOOD Sofia (Rheumatology Outpatient Office) | |
| Sofia, Bulgaria, 1784 | |
| Hungary | |
| Synexus Hungary Ltd | |
| Budapest, Hungary, 1036 | |
| Poland | |
| Synexus SCM Sp zoo | |
| Wroclaw, Poland, 50-088 | |
| South Africa | |
| Clinical Research Centres SA (Pty) Ltd | |
| Gauteng, Pretoria, South Africa, 0184 | |
| United Kingdom | |
| Synexus Thames Valley Clinical Research Centre | |
| Reading, Berkshire, United Kingdom, RG2 7AG | |
| Synexus Midlands Clinical Research Centre | |
| Edgbaston, Birmingham, United Kingdom, B15 2SQ | |
| Synexus Wales Clinical Research Centre | |
| Llanishen, Cardiff, United Kingdom, CF14 5GJ | |
| Synexus Scotland Clinical Research Centre | |
| Clydebank, Glasgow, United Kingdom, G81 2DR | |
| Synexus Merseyside Clinical Research Centre | |
| Waterloo, Liverpool, United Kingdom, L22 0LG | |
| Synexus Lancashire Clinical Research Centre | |
| Chorley, United Kingdom, PR7 7NA | |
| Synexus Manchester Clinical Research Centre | |
| Manchester, United Kingdom, M15 6SX | |
| Study Director: | David Krause, M.D. | Tarsa Therapeutics, Inc. |
More Information
| Responsible Party: | Tarsa Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00959764 History of Changes |
| Other Study ID Numbers: | UGL-OR0801, 2008-003322-42 |
| Study First Received: | August 14, 2009 |
| Last Updated: | January 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Salmon calcitonin Calcitonin |
Calcitonin Gene-Related Peptide Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Therapeutic Uses |