Postmenopausal Osteoporosis Clinical Trial
— VEROOfficial title:
Teriparatide and Risedronate in the Treatment of Patients With Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures
| Verified date | September 2019 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of therapy.
| Status | Completed |
| Enrollment | 1366 |
| Est. completion date | July 2016 |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 45 Years and older |
| Eligibility |
Inclusion Criteria: - Postmenopausal women with osteoporosis, as defined by low bone mineral density (BMD), i.e. anterior-posterior lumbar spine, total hip or femoral neck BMD =1.5 standard deviations below the average BMD for young, healthy, non-Hispanic, Caucasian women - A minimum of 2 moderate or 1 severe vertebral fragility fractures (confirmed by central reader) were required Exclusion Criteria: - Increased risk of osteosarcoma - History of unresolved skeletal diseases that affect bone metabolism - History of atypical subtrochanteric or diaphyseal femoral fractures - Abnormally high or low calcium levels - Abnormally high parathyroid hormone (PTH) levels - Severe vitamin D deficiency - Abnormal thyroid function not corrected by therapy - History of malignant neoplasms in the last 5 years - Active liver disease, clinical jaundice - Significant impairment of hepatic or renal function - History of nephro- or urolithiasis - Previous or planned kypho- or vertebroplasty - Active or risk for osteonecrosis of the jaw - Active or recent history of upper gastrointestinal disorders - Unable to stand or sit in the upright position for at least 30 minutes |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | For additional information regarding investigative sites for this trial, 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. | Buenos Aires | |
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| United States | For additional information regarding investigative sites for this trial, 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. | Pittsburgh | Pennsylvania |
| United States | For additional information regarding investigative sites for this trial, 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. | Seattle | Washington |
| United States | For additional information regarding investigative sites for this trial, 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. | Spokane | Washington |
| United States | For additional information regarding investigative sites for this trial, 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. | Topeka | Kansas |
| United States | For additional information regarding investigative sites for this trial, 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. | Tustin | California |
| United States | For additional information regarding investigative sites for this trial, 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. | Wyomissing | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Argentina, Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Greece, Hungary, Italy, Poland, Puerto Rico, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of Participants With New Vertebral Fractures | The incidence of new vertebral fractures was assessed by quantitative vertebral morphometry measurements (QM) with qualitative visual semiquantitative grading (SQ) confirmation. A new vertebral fracture was diagnosed in a vertebra that was non-fractured at the baseline radiological examination. It was defined as a loss of vertebral body height of at least 20% and 4 mm from the baseline radiograph by vertebral QM, based upon placement of six points by a trained, central reader. Any fractures identified by QM were confirmed using SQ: if the vertebral body also had an increase of one or more severity grade, it was considered an incident vertebral fracture. |
Baseline through 24 Months | |
| Secondary | Proportion of Participants With Pooled New and Worsening Vertebral Fractures | Worsening of a pre-existing fracture was considered if the decrease in vertebral height was at least one severity grade in the semi-quantitative assessment, confirmed by a trained central reader, where vertebrae were graded as normal (SQ0) or as with mild (SQ1), moderate (SQ2), or severe (SQ3) fractures, defined as ~20 to 25% (mild), ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 to L4). | Baseline through 24 Months | |
| Secondary | Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures | A clinical vertebral fracture was defined as a new or worsening vertebral fracture, confirmed by radiography, that was associated with signs and symptoms highly suggestive of a vertebral fracture. All non-vertebral fractures that occurred and were diagnosed between visits required the confirmation by the site investigators after evaluating the original x-ray film(s), the radiology or surgical report. For clinical vertebral fractures, the final confirmation of the diagnosis required the centralized evaluation by a trained, independent reader. |
Baseline through 24 Months | |
| Secondary | Proportion of Participants With Non-Vertebral Fragility Fractures | A non-vertebral fracture is a fracture at any of the following non-vertebral sites: clavicle, scapula, ribs, sternum, sacrum, coccyx, humerus, radius, ulna, carpus, pelvis, hip, femur, patella, tibia, fibula, ankle, calcaneus, tarsus, and metatarsal. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object were not considered fragility fractures but traumatic fractures. | Baseline through 24 Months | |
| Secondary | Proportion of Participants With Major Non-Vertebral Fragility Fractures | A major non-vertebral fracture is a fracture at any of the following non-vertebral sites hip, radius, humerus, ribs, pelvis, tibia and femur. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving. | Baseline through 24 Months | |
| Secondary | Proportion of Participants With New Moderate and/or Severe Vertebral Fractures | Vertebrae were graded as moderate (SQ2), or severe (SQ3) fractures, based on ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 through L4). | Baseline through 24 Months | |
| Secondary | Proportion of Participants With New Multiple (2 or More) Vertebral Fractures | Baseline through 24 Months | ||
| Secondary | Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures | Traumatic fractures were considered if resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object. | Baseline through 24 Months | |
| Secondary | Change From Baseline to 24 Months Endpoint in Height | Baseline, 24 Months | ||
| Secondary | Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale | Participants rated the worst back pain during the 24 hours preceding the visit at baseline and each post-baseline visit. An 11-point numerical back pain rating scale (rated from 0 = no back pain to 10 = worst possible back pain) was used. | Baseline, 24 Months | |
| Secondary | Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK) | The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.59 to 1.0. A higher score indicates better health state. | Baseline, 24 Months | |
| Secondary | Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US) | The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United States (US) cross walk algorithm, with scores ranging from -0.11 to 1.0. A higher score indicates better health state. | Baseline, 24 Months |
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