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Sponsored by: |
Nastech Pharmaceutical Company, Inc. |
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Information provided by: | Nastech Pharmaceutical Company, Inc. |
ClinicalTrials.gov Identifier: | NCT00624481 |
This study is being conducted to compare the effect of increasing nasal teriparatide dosing on percent change in Bone Mineral Density (BMD) of the lumbar spine after 24 weeks of therapy in postmenopausal women with low bone mineral density.
Condition | Intervention | Phase |
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Osteopenia Osteoporosis |
Drug: Teriparatide Drug: Teriparatide Nasal Spray |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, 24-Week, Multicenter, Randomized, Parallel-Group, Dose-Ranging Study To Evaluate The Effect Of Teriparatide Nasal Spray On Bone Mineral Density In Postmenopausal Women With Low Bone Mineral Density |
Estimated Enrollment: | 350 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Teriparatide
20ug subcutaneous injection daily for 24 weeks
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2: Experimental |
Drug: Teriparatide Nasal Spray
teriparatide intranasally daily for 24 weeks
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3: Experimental |
Drug: Teriparatide Nasal Spray
teriparatide intranasally daily for 24 weeks
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4: Experimental |
Drug: Teriparatide Nasal Spray
teriparatide intranasally daily for 24 weeks
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5: Experimental |
Drug: Teriparatide Nasal Spray
teriparatide intranasally daily for 24 weeks
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Ages Eligible for Study: | up to 89 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Nastech Pharmaceutical Company Inc. ( Nastech Pharmaceutical Company Inc. ( Gordon Brandt, M.D. / President ) ) |
Study ID Numbers: | C07-008 |
Study First Received: | February 19, 2008 |
Last Updated: | March 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00624481 History of Changes |
Health Authority: | United States: Food and Drug Administration |
osteoporosis osteopenia bone mineral density teriparatide |
Musculoskeletal Diseases Teriparatide Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Bone Diseases |
Musculoskeletal Diseases Teriparatide Physiological Effects of Drugs Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Bone Diseases Pharmacologic Actions |