VERO: VERtebral Fracture Treatment Comparisons in Osteoporotic Women
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01709110
Collaborator
(none)
1,366
103
2
45
13.3
0.3
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1366 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Teriparatide and Risedronate in the Treatment of Patients With Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures
Study Start Date
:
Oct 1, 2012
Actual Primary Completion Date
:
Jul 1, 2016
Actual Study Completion Date
:
Jul 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Teriparatide Teriparatide 20 microgram (µg) administered by subcutaneous (SC) injection once daily for 24 months. Placebo given orally once weekly for 24 months. Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment. |
Drug: Teriparatide
Administered SC
Other Names:
Drug: Placebo
Teriparatide arm placebo administered orally.
Risedronate arm placebo administered SC.
Drug: Calcium
Administered orally
Drug: Vitamin D
Administered orally
|
| Active Comparator: Risedronate Risedronate 35 milligram (mg) administered orally once weekly for 24 months. Placebo given by SC injection once daily for 24 months. Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment. |
Drug: Risedronate
Administered orally
Drug: Placebo
Teriparatide arm placebo administered orally.
Risedronate arm placebo administered SC.
Drug: Calcium
Administered orally
Drug: Vitamin D
Administered orally
|
Outcome Measures
Primary Outcome Measures
- Proportion of Participants With New Vertebral Fractures [Baseline through 24 Months]
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.
Secondary Outcome Measures
- Proportion of Participants With Pooled New and Worsening Vertebral Fractures [Baseline through 24 Months]
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).
- Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures [Baseline through 24 Months]
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.
- Proportion of Participants With Non-Vertebral Fragility Fractures [Baseline through 24 Months]
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.
- Proportion of Participants With Major Non-Vertebral Fragility Fractures [Baseline through 24 Months]
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.
- Proportion of Participants With New Moderate and/or Severe Vertebral Fractures [Baseline through 24 Months]
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).
- Proportion of Participants With New Multiple (2 or More) Vertebral Fractures [Baseline through 24 Months]
- Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures [Baseline through 24 Months]
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.
- Change From Baseline to 24 Months Endpoint in Height [Baseline, 24 Months]
- Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale [Baseline, 24 Months]
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.
- Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK) [Baseline, 24 Months]
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.
- Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US) [Baseline, 24 Months]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
45 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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. | Birmingham | Alabama | United States | 35294 |
| 2 | 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. | Concord | California | United States | 94520 |
| 3 | 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. | Fresno | California | United States | 93720 |
| 4 | 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. | Laguna Hills | California | United States | 92653 |
| 5 | 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. | Lancaster | California | United States | 93534 |
| 6 | 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 | 92780 |
| 7 | 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. | Lakewood | Colorado | United States | 80227 |
| 8 | 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. | Danbury | Connecticut | United States | 06810 |
| 9 | 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. | Orlando | Florida | United States | 32804 |
| 10 | 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. | Gainesville | Georgia | United States | 30501 |
| 11 | 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. | Evansville | Indiana | United States | 47714 |
| 12 | 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. | Indianapolis | Indiana | United States | 46202 |
| 13 | 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 | 66606 |
| 14 | 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. | Bethesda | Maryland | United States | 20817 |
| 15 | 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. | Detroit | Michigan | United States | 48202 |
| 16 | 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. | Omaha | Nebraska | United States | 68131 |
| 17 | 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. | Clifton | New Jersey | United States | 07012 |
| 18 | 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. | Freehold | New Jersey | United States | 07728 |
| 19 | 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. | Albuquerque | New Mexico | United States | 87106 |
| 20 | 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. | Asheville | North Carolina | United States | 28803 |
| 21 | 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. | Greensboro | North Carolina | United States | 27408 |
| 22 | 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. | Fargo | North Dakota | United States | 58103 |
| 23 | 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. | Bend | Oregon | United States | 97701 |
| 24 | 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. | Duncansville | Pennsylvania | United States | 16635 |
| 25 | 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 | 15213 |
| 26 | 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 | United States | 19610 |
| 27 | 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. | Dallas | Texas | United States | 75231 |
| 28 | 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 | 98122 |
| 29 | 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 | 99204 |
| 30 | 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. | Madison | Wisconsin | United States | 53705 |
| 31 | 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 | Argentina | C1128AAF | |
| 32 | 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. | Caba | Argentina | C1425AGC | |
| 33 | 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. | Mar Del Plata | Argentina | B7600DHK | |
| 34 | 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. | Graz | Austria | 8036 | |
| 35 | 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. | Hohenems | Austria | 6845 | |
| 36 | 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. | Linz | Austria | 4020 | |
| 37 | 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. | Vienna | Austria | A-1060 | |
| 38 | 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. | Brussels | Belgium | 1070 | |
| 39 | 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. | Genk | Belgium | 3600 | |
| 40 | 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. | Gent | Belgium | 9000 | |
| 41 | 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. | Gilly | Belgium | 6060 | |
| 42 | 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. | Laken | Belgium | 1020 | |
| 43 | 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. | Leuven | Belgium | 3000 | |
| 44 | 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. | Liège | Belgium | 4020 | |
| 45 | 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. | Merksem | Belgium | 2170 | |
| 46 | 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. | Mons | Belgium | 7000 | |
| 47 | 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. | Brasilia | Brazil | 71625-009 | |
| 48 | 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. | Rio De Janeiro | Brazil | 22271-100 | |
| 49 | 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. | São Paulo | Brazil | 05437-010 | |
| 50 | 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. | Kelowna | British Columbia | Canada | V1Y3G5 |
| 51 | 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. | Vancouver | British Columbia | Canada | V5Z 4E1 |
| 52 | 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. | Halifax | Nova Scotia | Canada | B3H 1V7 |
| 53 | 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. | Hamilton | Ontario | Canada | L8N 1Y2 |
| 54 | 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. | Toronto | Ontario | Canada | M5G 2C4 |
| 55 | 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. | Montreal | Quebec | Canada | H3T 1E2 |
| 56 | 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. | Sainte-Foy | Quebec | Canada | G1V 3M7 |
| 57 | 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. | Trois-Rivieres | Quebec | Canada | G8Z 1Y2 |
| 58 | 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. | Saskatoon | Saskatchewan | Canada | S7K 0H6 |
| 59 | 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. | Ceske Budejovice | Czechia | 37005 | |
| 60 | 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. | Klatovy | Czechia | 33938 | |
| 61 | 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. | Prague | Czechia | 128 08 | |
| 62 | 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. | Uherske Hradiste | Czechia | 686 01 | |
| 63 | 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. | Caen | France | 14033 | |
| 64 | 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. | La Crau | France | 83260 | |
| 65 | 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. | Lyon | France | 69003 | |
| 66 | 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. | Orleans | France | 45032 | |
| 67 | 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. | Saint-Etienne | France | 42055 | |
| 68 | 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. | Toulouse | France | 31059 | |
| 69 | 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. | Dresden | Germany | 01067 | |
| 70 | 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. | Frankfurt | Germany | 60528 | |
| 71 | 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. | Hamburg | Germany | 22415 | |
| 72 | 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. | Leipzig | Germany | 04103 | |
| 73 | 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. | Magdeburg | Germany | 39110 | |
| 74 | 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. | Marburg | Germany | 35043 | |
| 75 | 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. | Athens | Greece | 10676 | |
| 76 | 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. | Kifissia | Greece | 14561 | |
| 77 | 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. | Patras | Greece | 26500 | |
| 78 | 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. | Thessaloniki | Greece | 54642 | |
| 79 | 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. | Budapest | Hungary | 1094 | |
| 80 | 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. | Debrecen | Hungary | 4043 | |
| 81 | 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. | Eger | Hungary | 3300 | |
| 82 | 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. | Kaposvar | Hungary | 7400 | |
| 83 | 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. | Szeged | Hungary | 6720 | |
| 84 | 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. | Firenze | Italy | 50134 | |
| 85 | 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. | Genova-Nervi | Italy | 16167 | |
| 86 | 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. | Orbassano | Italy | 10043 | |
| 87 | 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. | Padova | Italy | 35128 | |
| 88 | 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. | Rome | Italy | 00161 | |
| 89 | 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. | Torino | Italy | 10126 | |
| 90 | 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. | Valeggio Sul Mincio | Italy | 37067 | |
| 91 | 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. | Bialystok | Poland | 15-351 | |
| 92 | 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. | Elblag | Poland | 82-300 | |
| 93 | 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. | Lublin | Poland | 20-582 | |
| 94 | 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. | Poznan | Poland | 60-218 | |
| 95 | 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. | Swidnik | Poland | 21-040 | |
| 96 | 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. | Warsaw | Poland | 02-118 | |
| 97 | 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. | San Juan | Puerto Rico | 00918 | |
| 98 | 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. | Alcira | Spain | 46600 | |
| 99 | 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. | Barcelona | Spain | 08025 | |
| 100 | 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. | Cadiz | Spain | 11009 | |
| 101 | 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. | Madrid | Spain | 28046 | |
| 102 | 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. | Sabadell | Spain | 08208 | |
| 103 | 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. | Valencia | Spain | 46026 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01709110
Other Study ID Numbers:
- 14536
- B3D-EW-GHDW
- 2012-000123-41
First Posted:
Oct 17, 2012
Last Update Posted:
Sep 23, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram (µg) administered by subcutaneous (SC) injection once daily for 24 months. Placebo given orally once weekly for 24 months. | Risedronate 35 milligram (mg) administered orally once weekly for 24 months. Placebo given by SC injection once daily for 24 months. |
| Period Title: Overall Study | ||
| STARTED | 683 | 683 |
| Received at Least One Dose of Study Drug | 680 | 680 |
| COMPLETED | 498 | 515 |
| NOT COMPLETED | 185 | 168 |
Baseline Characteristics
| Arm/Group Title | Teriparatide | Risedronate | Total |
|---|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months. Placebo given orally once weekly for 24 months. | Risedronate 35 milligram administered orally once weekly for 24 months. Placebo given by SC injection once daily for 24 months. | Total of all reporting groups |
| Overall Participants | 680 | 680 | 1360 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
72.6
(8.77)
|
71.6
(8.58)
|
72.1
(8.68)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
680
100%
|
680
100%
|
1360
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
104
15.3%
|
99
14.6%
|
203
14.9%
|
| Not Hispanic or Latino |
310
45.6%
|
302
44.4%
|
612
45%
|
| Unknown or Not Reported |
266
39.1%
|
279
41%
|
545
40.1%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
1
0.1%
|
1
0.1%
|
2
0.1%
|
| Asian |
4
0.6%
|
8
1.2%
|
12
0.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
5
0.7%
|
15
2.2%
|
20
1.5%
|
| White |
670
98.5%
|
653
96%
|
1323
97.3%
|
| More than one race |
0
0%
|
3
0.4%
|
3
0.2%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||
| Argentina |
79
11.6%
|
78
11.5%
|
157
11.5%
|
| Hungary |
68
10%
|
53
7.8%
|
121
8.9%
|
| Czech Republic |
68
10%
|
68
10%
|
136
10%
|
| United States |
55
8.1%
|
67
9.9%
|
122
9%
|
| Spain |
66
9.7%
|
55
8.1%
|
121
8.9%
|
| Greece |
27
4%
|
13
1.9%
|
40
2.9%
|
| Canada |
36
5.3%
|
33
4.9%
|
69
5.1%
|
| Austria |
24
3.5%
|
29
4.3%
|
53
3.9%
|
| Belgium |
43
6.3%
|
45
6.6%
|
88
6.5%
|
| Poland |
55
8.1%
|
63
9.3%
|
118
8.7%
|
| Brazil |
63
9.3%
|
81
11.9%
|
144
10.6%
|
| Italy |
33
4.9%
|
36
5.3%
|
69
5.1%
|
| France |
26
3.8%
|
29
4.3%
|
55
4%
|
| Germany |
37
5.4%
|
30
4.4%
|
67
4.9%
|
| Distribution of Stratification Factors (Count of Participants) | |||
| Vertebral Fracture with Bisphosphonate Use |
82
12.1%
|
79
11.6%
|
161
11.8%
|
| With Vertebral Fracture without Bisphosphonate Use |
170
25%
|
165
24.3%
|
335
24.6%
|
| Without Vertebral Fracture with Bisphosphonate Use |
184
27.1%
|
189
27.8%
|
373
27.4%
|
| Without Vertebral Fracture without Bisphosphonate |
244
35.9%
|
247
36.3%
|
491
36.1%
|
| Bone Mineral Density (BMD) (Gram per square centimeter (g/cm2)) [Mean (Standard Deviation) ] | |||
| Lumbar Spine |
0.858
(0.1541)
|
0.856
(0.1473)
|
0.857
(0.1506)
|
| Femoral Neck |
0.662
(0.1085)
|
0.667
(0.1129)
|
0.664
(0.1107)
|
| Total Hip |
0.736
(0.1065)
|
0.735
(0.1165)
|
0.735
(0.1116)
|
| Vertebral Fracture Status (Count of Participants) | |||
| 1 Fracture |
231
34%
|
240
35.3%
|
471
34.6%
|
| 2 Fractures |
178
26.2%
|
174
25.6%
|
352
25.9%
|
| 3 Fractures |
104
15.3%
|
101
14.9%
|
205
15.1%
|
| 4 Fractures |
60
8.8%
|
62
9.1%
|
122
9%
|
| 5 or More Fractures |
106
15.6%
|
102
15%
|
208
15.3%
|
Outcome Measures
| Title | Proportion of Participants With New Vertebral Fractures |
|---|---|
| Description | 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. |
| Time Frame | Baseline through 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months. Placebo given orally once weekly for 24 months. | Risedronate 35 milligram administered orally once weekly for 24 months. Placebo given by SC injection once daily for 24 months. |
| Measure Participants | 516 | 533 |
| Number [Participants (with at least one event)] |
28
4.1%
|
64
9.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Teriparatide, Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.000094 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.4071 | |
| Confidence Interval |
(2-Sided) 95% 0.256 to 0.647 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Teriparatide, Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.000094 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use. | |
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 0.4431 | |
| Confidence Interval |
(2-Sided) 95% 0.290 to 0.677 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Proportion of Participants With Pooled New and Worsening Vertebral Fractures |
|---|---|
| Description | 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). |
| Time Frame | Baseline through 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months. Placebo given orally once weekly for 24 months. | Risedronate 35 milligram administered orally once weekly for 24 months. Placebo given by SC injection once daily for 24 months. |
| Measure Participants | 516 | 533 |
| Number [Participants (with at least one event)] |
31
4.6%
|
69
10.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Teriparatide, Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.000075 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Cochran-Mantel-Haenszel was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.4187 | |
| Confidence Interval |
(2-Sided) 95% 0.269 to 0.652 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Teriparatide, Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.000075 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Cochran-Mantel-Haenszel was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use. | |
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 0.4561 | |
| Confidence Interval |
(2-Sided) 95% 0.305 to 0.682 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures |
|---|---|
| Description | 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. |
| Time Frame | Baseline through 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set: all participants who received at least one dose of study drug and had evaluable data. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months. Placebo given orally once weekly for 24 months. | Risedronate 35 milligram administered orally once weekly for 24 months. Placebo given by SC injection once daily for 24 months. |
| Measure Participants | 680 | 680 |
| Number [Participants (with at least one event)] |
30
4.4%
|
61
9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Teriparatide, Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.000869 |
| Comments | ||
| Method | Stratified Log Rank | |
| Comments | Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use. | |
| Method of Estimation | Estimation Parameter | Stratified Hazard Ratio (HR) |
| Estimated Value | 0.4831 | |
| Confidence Interval |
(2-Sided) 95% 0.316 to 0.739 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations. | |
| Title | Proportion of Participants With Non-Vertebral Fragility Fractures |
|---|---|
| Description | 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. |
| Time Frame | Baseline through 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set: all participants who received at least one dose of study drug and had evaluable data. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months. Placebo given orally once weekly for 24 months. | Risedronate 35 milligram administered orally once weekly for 24 months. Placebo given by SC injection once daily for 24 months. |
| Measure Participants | 680 | 680 |
| Number [Participants (with at least one event)] |
25
3.7%
|
38
5.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Teriparatide, Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.099023 |
| Comments | ||
| Method | Stratified Log Rank | |
| Comments | Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use. | |
| Method of Estimation | Estimation Parameter | Stratified Hazard Ratio (HR) |
| Estimated Value | 0.6553 | |
| Confidence Interval |
(2-Sided) 95% 0.390 to 1.101 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations. | |
| Title | Proportion of Participants With Major Non-Vertebral Fragility Fractures |
|---|---|
| Description | 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. |
| Time Frame | Baseline through 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set: all participants who received at least one dose of study drug and had evaluable data. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months. Placebo given orally once weekly for 24 months. | Risedronate 35 milligram administered orally once weekly for 24 months. Placebo given by SC injection once daily for 24 months. |
| Measure Participants | 680 | 680 |
| Number [Participants (with at least one event)] |
18
2.6%
|
31
4.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Teriparatide, Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.062432 |
| Comments | ||
| Method | Stratified Log Rank | |
| Comments | Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use. | |
| Method of Estimation | Estimation Parameter | Stratified Hazard Ratio (HR) |
| Estimated Value | 0.5786 | |
| Confidence Interval |
(2-Sided) 95% 0.318 to 1.052 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations. | |
| Title | Proportion of Participants With New Moderate and/or Severe Vertebral Fractures |
|---|---|
| Description | 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). |
| Time Frame | Baseline through 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months. Placebo given orally once weekly for 24 months. | Risedronate 35 milligram administered orally once weekly for 24 months. Placebo given by SC injection once daily for 24 months. |
| Measure Participants | 516 | 533 |
| Number [Participants (with at least one event)] |
26
3.8%
|
63
9.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Teriparatide, Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.3812 | |
| Confidence Interval |
(2-Sided) 95% 0.237 to 0.614 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Teriparatide, Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use. | |
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 0.4173 | |
| Confidence Interval |
(2-Sided) 95% 0.270 to 0.646 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Proportion of Participants With New Multiple (2 or More) Vertebral Fractures |
|---|---|
| Description | |
| Time Frame | Baseline through 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months. Placebo given orally once weekly for 24 months. | Risedronate 35 milligram administered orally once weekly for 24 months. Placebo given by SC injection once daily for 24 months. |
| Measure Participants | 516 | 533 |
| Number [Participants (with at least one event)] |
2
0.3%
|
12
1.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Teriparatide, Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.1593 | |
| Confidence Interval |
(2-Sided) 95% 0.035 to 0.728 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Teriparatide, Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use. | |
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 0.1643 | |
| Confidence Interval |
(2-Sided) 95% 0.036 to 0.744 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures |
|---|---|
| Description | 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. |
| Time Frame | Baseline through 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set: all participants who received at least one dose of study drug and had evaluable data. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months. Placebo given orally once weekly for 24 months. | Risedronate 35 milligram administered orally once weekly for 24 months. Placebo given by SC injection once daily for 24 months. |
| Measure Participants | 680 | 680 |
| Number [Participants (with at least one event)] |
40
5.9%
|
57
8.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Teriparatide, Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.078 |
| Comments | ||
| Method | Stratified Log Rank | |
| Comments | Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use. | |
| Method of Estimation | Estimation Parameter | Stratified Hazard Ratio (HR) |
| Estimated Value | 0.6960 | |
| Confidence Interval |
(2-Sided) 95% 0.461 to 1.050 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The Stratified Hazard Ratio estimates and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations. | |
| Title | Change From Baseline to 24 Months Endpoint in Height |
|---|---|
| Description | |
| Time Frame | Baseline, 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set: all participants who received at least one dose of study drug and had evaluable data. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months. Placebo given orally once weekly for 24 months. | Risedronate 35 milligram administered orally once weekly for 24 months. Placebo given by SC injection once daily for 24 months. |
| Measure Participants | 565 | 580 |
| Baseline |
154.7
(7.15)
|
155.0
(7.40)
|
| 24 Months |
154.3
(7.05)
|
154.5
(7.42)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Teriparatide, Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.093 |
| Comments | Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate and baseline body height(cm). | |
| Method | Mixed Models Analysis | |
| Comments | An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean |
| Estimated Value | -0.13 | |
| Confidence Interval |
(2-Sided) 95% -0.28 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.08 |
|
| Estimation Comments | Treatment difference was calculated as Teriparatide - Risedronate. | |
| Title | Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set: all participants who received at least one dose of study drug and had evaluable data. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months. Placebo given orally once weekly for 24 months. | Risedronate 35 milligram administered orally once weekly for 24 months. Placebo given by SC injection once daily for 24 months. |
| Measure Participants | 642 | 648 |
| Baseline |
4.5
(2.90)
|
4.5
(2.91)
|
| 24 Months |
3.4
(2.95)
|
3.4
(2.89)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Teriparatide, Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.585 |
| Comments | Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate and baseline back pain (no pain - worst pain [0-10]). | |
| Method | Mixed Models Analysis | |
| Comments | An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean |
| Estimated Value | -0.09 | |
| Confidence Interval |
(2-Sided) 95% -0.42 to 0.24 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | Treatment difference was calculated as Teriparatide - Risedronate. | |
| Title | Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK) |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set: all participants who received at least one dose of study drug and had evaluable data. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months. Placebo given orally once weekly for 24 months. | Risedronate 35 milligram administered orally once weekly for 24 months. Placebo given by SC injection once daily for 24 months. |
| Measure Participants | 642 | 647 |
| Baseline |
0.59
(0.243)
|
0.62
(0.228)
|
| 24 Months |
0.65
(0.249)
|
0.68
(0.205)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Teriparatide, Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.757 |
| Comments | Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate baseline EQ-5D-5L (UK). | |
| Method | Mixed Models Analysis | |
| Comments | An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean |
| Estimated Value | -0.00 | |
| Confidence Interval |
(2-Sided) 95% -0.03 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.01 |
|
| Estimation Comments | Treatment difference was calculated as Teriparatide - Risedronate. | |
| Title | Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US) |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set: all participants who received at least one dose of study drug and had evaluable data. |
| Arm/Group Title | Teriparatide | Risedronate |
|---|---|---|
| Arm/Group Description | Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months. Placebo given orally once weekly for 24 months. | Risedronate 35 milligram administered orally once weekly for 24 months. Placebo given by SC injection once daily for 24 months. |
| Measure Participants | 642 | 647 |
| Baseline |
0.70
(0.167)
|
0.72
(0.159)
|
| 24 Months |
0.74
(0.176)
|
0.76
(0.145)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Teriparatide, Risedronate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.694 |
| Comments | Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate baseline EQ-5D-5L (US). | |
| Method | Mixed Models Analysis | |
| Comments | An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant. | |
| Method of Estimation | Estimation Parameter | Least Squares Mean |
| Estimated Value | -0.00 | |
| Confidence Interval |
(2-Sided) 95% -0.02 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.01 |
|
| Estimation Comments | Treatment difference was calculated as Teriparatide - Risedronate. | |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Teriparatide | Risedronate | ||
| Arm/Group Description | Teriparatide 20 microgram administered by subcutaneous injection once daily for 24 months. Placebo given orally once weekly for 24 months. | Risedronate 35 milligram administered orally once weekly for 24 months. Placebo given by SC injection once daily for 24 months. | ||
All Cause Mortality |
||||
| Teriparatide | Risedronate | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Teriparatide | Risedronate | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 138/683 (20.2%) | 117/683 (17.1%) | ||
| Blood and lymphatic system disorders | ||||
| Coagulopathy | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Haemolytic anaemia | 0/683 (0%) | 0 | 1/683 (0.1%) | 2 |
| Immune thrombocytopenic purpura | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Microcytic anaemia | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Pernicious anaemia | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Thrombocytopenia | 2/683 (0.3%) | 2 | 0/683 (0%) | 0 |
| Cardiac disorders | ||||
| Acute myocardial infarction | 3/683 (0.4%) | 3 | 1/683 (0.1%) | 1 |
| Angina pectoris | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Atrial fibrillation | 5/683 (0.7%) | 5 | 3/683 (0.4%) | 3 |
| Atrioventricular block | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Atrioventricular block complete | 0/683 (0%) | 0 | 2/683 (0.3%) | 2 |
| Cardiac arrest | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Cardiac failure | 2/683 (0.3%) | 2 | 2/683 (0.3%) | 2 |
| Cardiac failure congestive | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Cardiac valve disease | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Coronary artery disease | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Mitral valve incompetence | 1/683 (0.1%) | 1 | 1/683 (0.1%) | 1 |
| Myocardial infarction | 2/683 (0.3%) | 2 | 1/683 (0.1%) | 1 |
| Pericarditis | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Supraventricular tachycardia | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Tricuspid valve incompetence | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||
| Left ventricle outflow tract obstruction | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Endocrine disorders | ||||
| Goitre | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Eye disorders | ||||
| Cataract | 0/683 (0%) | 0 | 3/683 (0.4%) | 3 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Diverticulum | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Diverticulum intestinal | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Duodenitis | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Dysphagia | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Enteritis | 2/683 (0.3%) | 2 | 0/683 (0%) | 0 |
| Enterocolitis | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Femoral hernia, obstructive | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Gastritis erosive | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Haemorrhoidal haemorrhage | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Hiatus hernia | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Ileus | 1/683 (0.1%) | 1 | 1/683 (0.1%) | 1 |
| Intestinal obstruction | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Large intestine polyp | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Nausea | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Oesophageal achalasia | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Pancreatic cyst | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Pancreatitis acute | 1/683 (0.1%) | 1 | 1/683 (0.1%) | 1 |
| Regurgitation | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Small intestinal obstruction | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Umbilical hernia | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| General disorders | ||||
| Asthenia | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Death | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Oedema peripheral | 1/683 (0.1%) | 2 | 0/683 (0%) | 0 |
| Performance status decreased | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Sudden cardiac death | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Hepatobiliary disorders | ||||
| Biliary colic | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Cholecystitis acute | 0/683 (0%) | 0 | 2/683 (0.3%) | 2 |
| Ischaemic hepatitis | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Infections and infestations | ||||
| Abdominal sepsis | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Appendicitis | 3/683 (0.4%) | 3 | 0/683 (0%) | 0 |
| Cellulitis | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Clostridium difficile infection | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Diverticulitis | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Erysipelas | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Escherichia pyelonephritis | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Gastroenteritis | 2/683 (0.3%) | 2 | 3/683 (0.4%) | 3 |
| Gastroenteritis viral | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Gastrointestinal infection | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Lower respiratory tract infection | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Peritonitis | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Pneumonia | 3/683 (0.4%) | 3 | 3/683 (0.4%) | 3 |
| Postoperative wound infection | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Pyelonephritis acute | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Pyonephrosis | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Sepsis | 1/683 (0.1%) | 1 | 1/683 (0.1%) | 1 |
| Urinary tract infection | 2/683 (0.3%) | 3 | 1/683 (0.1%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Ankle fracture | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Cervical vertebral fracture | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Clavicle fracture | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Concussion | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Contusion | 0/683 (0%) | 0 | 2/683 (0.3%) | 2 |
| Craniocerebral injury | 2/683 (0.3%) | 2 | 1/683 (0.1%) | 1 |
| Fall | 15/683 (2.2%) | 16 | 19/683 (2.8%) | 21 |
| Femoral neck fracture | 4/683 (0.6%) | 4 | 3/683 (0.4%) | 3 |
| Femur fracture | 3/683 (0.4%) | 4 | 6/683 (0.9%) | 7 |
| Fibula fracture | 0/683 (0%) | 0 | 2/683 (0.3%) | 2 |
| Foot fracture | 1/683 (0.1%) | 1 | 1/683 (0.1%) | 1 |
| Forearm fracture | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Hand fracture | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Hip fracture | 1/683 (0.1%) | 1 | 5/683 (0.7%) | 5 |
| Humerus fracture | 3/683 (0.4%) | 3 | 5/683 (0.7%) | 5 |
| Incisional hernia | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Injury | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Lumbar vertebral fracture | 3/683 (0.4%) | 4 | 6/683 (0.9%) | 6 |
| Meniscus injury | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Multiple injuries | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Overdose | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Patella fracture | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Pelvic fracture | 0/683 (0%) | 0 | 3/683 (0.4%) | 3 |
| Post procedural stroke | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Procedural nausea | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Procedural vomiting | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Radius fracture | 2/683 (0.3%) | 2 | 2/683 (0.3%) | 2 |
| Rib fracture | 3/683 (0.4%) | 4 | 1/683 (0.1%) | 3 |
| Scapula fracture | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Spinal compression fracture | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Spinal fracture | 0/683 (0%) | 0 | 2/683 (0.3%) | 2 |
| Subcutaneous haematoma | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Subdural haematoma | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Tendon rupture | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Thoracic vertebral fracture | 2/683 (0.3%) | 6 | 3/683 (0.4%) | 4 |
| Tibia fracture | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Ulna fracture | 1/683 (0.1%) | 1 | 3/683 (0.4%) | 3 |
| Upper limb fracture | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Wrist fracture | 1/683 (0.1%) | 1 | 1/683 (0.1%) | 1 |
| Investigations | ||||
| Blood pressure increased | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Carbohydrate antigen 19-9 increased | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| General physical condition abnormal | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Weight decreased | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Dehydration | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Hyperlipidaemia | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Hypoglycaemia | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Hypokalaemia | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Hyponatraemia | 0/683 (0%) | 0 | 2/683 (0.3%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 3/683 (0.4%) | 3 | 5/683 (0.7%) | 5 |
| Kyphosis | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Lumbar spinal stenosis | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Osteitis | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Osteoarthritis | 3/683 (0.4%) | 3 | 4/683 (0.6%) | 4 |
| Osteonecrosis | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Periostitis | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Pseudarthrosis | 1/683 (0.1%) | 1 | 1/683 (0.1%) | 1 |
| Rheumatoid arthritis | 1/683 (0.1%) | 1 | 1/683 (0.1%) | 1 |
| Rotator cuff syndrome | 2/683 (0.3%) | 2 | 0/683 (0%) | 0 |
| Spinal column stenosis | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Synovial cyst | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Tendon disorder | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Vertebral foraminal stenosis | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Acute myeloid leukaemia | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Basal cell carcinoma | 1/683 (0.1%) | 1 | 2/683 (0.3%) | 2 |
| Bladder cancer | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Breast cancer | 3/683 (0.4%) | 3 | 0/683 (0%) | 0 |
| Breast cancer metastatic | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Breast neoplasm | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Cervix carcinoma | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Chondrosarcoma | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Cystadenocarcinoma ovary | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Endometrial cancer | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Hypergammaglobulinaemia benign monoclonal | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Invasive breast carcinoma | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Invasive ductal breast carcinoma | 1/683 (0.1%) | 1 | 1/683 (0.1%) | 1 |
| Laryngeal cancer | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Lung neoplasm | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Lung neoplasm malignant | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Metastases to bone | 2/683 (0.3%) | 2 | 0/683 (0%) | 0 |
| Non-small cell lung cancer | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Ovarian cancer | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Pancreatic carcinoma metastatic | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Papillary thyroid cancer | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Plasma cell myeloma | 1/683 (0.1%) | 1 | 2/683 (0.3%) | 2 |
| Squamous cell carcinoma | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Squamous cell carcinoma of skin | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Nervous system disorders | ||||
| Carotid artery stenosis | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Cerebellar ischaemia | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Cerebral artery embolism | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Cerebrovascular accident | 2/683 (0.3%) | 2 | 1/683 (0.1%) | 1 |
| Depressed level of consciousness | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Embolic stroke | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Epilepsy | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Hemiparesis | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Intercostal neuralgia | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Ischaemic stroke | 2/683 (0.3%) | 2 | 3/683 (0.4%) | 3 |
| Multiple sclerosis | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Presyncope | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Radicular pain | 1/683 (0.1%) | 1 | 1/683 (0.1%) | 1 |
| Radiculopathy | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Sciatica | 2/683 (0.3%) | 2 | 0/683 (0%) | 0 |
| Spinal cord compression | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Syncope | 3/683 (0.4%) | 3 | 2/683 (0.3%) | 2 |
| Transient ischaemic attack | 2/683 (0.3%) | 2 | 2/683 (0.3%) | 2 |
| Tremor | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Vascular dementia | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Vascular encephalopathy | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Product Issues | ||||
| Device dislocation | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Device malfunction | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Psychiatric disorders | ||||
| Alcohol abuse | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Anxiety | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Confusional state | 1/683 (0.1%) | 1 | 1/683 (0.1%) | 1 |
| Delirium | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Major depression | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Renal and urinary disorders | ||||
| Acute kidney injury | 2/683 (0.3%) | 2 | 1/683 (0.1%) | 1 |
| Calculus urinary | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Hydronephrosis | 0/683 (0%) | 0 | 2/683 (0.3%) | 2 |
| Nephrotic syndrome | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Renal failure | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Renal impairment | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Ureterolithiasis | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Reproductive system and breast disorders | ||||
| Female genital tract fistula | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Ovarian cyst | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Uterine prolapse | 1/683 (0.1%) | 1 | 1/683 (0.1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute pulmonary oedema | 1/683 (0.1%) | 1 | 2/683 (0.3%) | 2 |
| Asthma | 1/683 (0.1%) | 1 | 2/683 (0.3%) | 2 |
| Chronic obstructive pulmonary disease | 2/683 (0.3%) | 2 | 1/683 (0.1%) | 1 |
| Chronic respiratory failure | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Dyspnoea | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Haemothorax | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Laryngospasm | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Lung disorder | 1/683 (0.1%) | 1 | 1/683 (0.1%) | 1 |
| Pleural effusion | 3/683 (0.4%) | 3 | 1/683 (0.1%) | 1 |
| Pleurisy | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Pulmonary embolism | 2/683 (0.3%) | 2 | 1/683 (0.1%) | 1 |
| Respiratory failure | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Skin ulcer | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Systemic lupus erythematosus rash | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Vascular disorders | ||||
| Aortic aneurysm | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Aortic stenosis | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Arterial disorder | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Deep vein thrombosis | 2/683 (0.3%) | 2 | 3/683 (0.4%) | 3 |
| Granulomatosis with polyangiitis | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Hypertension | 1/683 (0.1%) | 1 | 2/683 (0.3%) | 2 |
| Hypertensive crisis | 0/683 (0%) | 0 | 2/683 (0.3%) | 2 |
| Hypotension | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Hypovolaemic shock | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Peripheral arterial occlusive disease | 4/683 (0.6%) | 4 | 0/683 (0%) | 0 |
| Peripheral artery occlusion | 1/683 (0.1%) | 1 | 0/683 (0%) | 0 |
| Subclavian artery occlusion | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
| Vena cava thrombosis | 0/683 (0%) | 0 | 1/683 (0.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Teriparatide | Risedronate | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 130/683 (19%) | 130/683 (19%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 44/683 (6.4%) | 54 | 51/683 (7.5%) | 63 |
| Back pain | 73/683 (10.7%) | 77 | 79/683 (11.6%) | 89 |
| Pain in extremity | 37/683 (5.4%) | 45 | 0/683 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01709110
Other Study ID Numbers:
- 14536
- B3D-EW-GHDW
- 2012-000123-41
First Posted:
Oct 17, 2012
Last Update Posted:
Sep 23, 2019
Last Verified:
Sep 1, 2019