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| Sponsor: | Unigene Laboratories Inc. |
|---|---|
| Information provided by: | Unigene Laboratories 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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
| 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 |
| Estimated Enrollment: | 520 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Oral Calcitonin: Experimental |
Drug: Oral Calcitonin
Calcitonin tablets
|
| Nasal Calcitonin: Active Comparator |
Drug: Nasal Calcitonin
Nasal Calcitonin Spray
|
| Placebo: Placebo Comparator |
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
Show 20 Study Locations| Study Director: | Kristine A Erickson, Ph.D. | Unigene Laboratories Inc. |
More Information
| Responsible Party: | Unigene Laboratories, Inc. ( Dr. Kristine A. Erickson, Senior Director of Clinical Affairs ) |
| Study ID Numbers: | UGL-OR0801, EudraCT No.: 2008-003322-42 |
| Study First Received: | August 14, 2009 |
| Last Updated: | February 4, 2010 |
| ClinicalTrials.gov Identifier: | NCT00959764 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Calcitonin Vasodilator Agents Physiological Effects of Drugs Osteoporosis Bone Diseases, Metabolic Bone Density Conservation Agents Cardiovascular Agents |
Bone Diseases Salmon calcitonin Pharmacologic Actions Calcitonin Gene-Related Peptide Musculoskeletal Diseases Therapeutic Uses Osteoporosis, Postmenopausal |