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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00696644 |
This observational study will evaluate the proportion of new vertebral and non vertebral fragility fractures in patients with severe osteoporosis treated with anti-osteoporotic drugs. This study will also evaluate BMD, compliance to treatment, back pain and the health-related quality of life.
Condition | Intervention |
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Osteoporosis, Postmenopausal |
Drug: Teriparatide |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | An Italian Observational Study to Evaluate Fracture Outcomes, Compliance to Treatment, Back Pain, Health-Related Quality of Life in Patients With Severe Osteoporosis Treated According to Common Clinical Practice |
Estimated Enrollment: | 650 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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A
Postmenopausal women and men aged > 21 years old affected by severe osteoporosis
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Drug: Teriparatide
20 mcg daily subcutaneous for 18 months.
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The participants should be treated with anabolic therapy for osteoporosis (Teriparatide or PTH 1-84) for 18 months and should be followed up for subsequent 6 months. The treatment is expected to improve bone mineral density, back pain and reduce the risk of new fractures due to osteoporosis. The outcomes will be evaluated by bone densitometry at the lumbar spine and femoral neck, by standard radiographs, by measurements of bone formation marker (P1NP) and by questionnaires on back pain and quality of life. Postmenopausal women and men over 21 years old may be included if they have:
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Primary care clinic
Inclusion Criteria:
Exclusion Criteria:
Italy, Verona | |
For additional information regarding investigative sites for this study, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Valeggio sul Mincio, Verona, Italy, 36067 |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 12456, B3D-IT-B014 |
Study First Received: | June 11, 2008 |
Last Updated: | March 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00696644 History of Changes |
Health Authority: | Italy: Ministry of Health |
Musculoskeletal Diseases Teriparatide Fractures, Bone Osteoporosis, Postmenopausal Quality of Life Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Pain Bone Diseases Back Pain |
Musculoskeletal Diseases Teriparatide Physiological Effects of Drugs Osteoporosis, Postmenopausal Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Bone Diseases Pharmacologic Actions |