Trial · NCT01709110
VERtebral Fracture Treatment Comparisons in Osteoporotic Women
NCT01709110, Phase 4, Completed, Eli Lilly and Company; results first posted 2018-01-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. VERtebral Fracture Treatment Comparisons in Osteoporotic Women. Trials, record NCT01709110. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01709110
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- VERtebral Fracture Treatment Comparisons in Osteoporotic Women
- NCT number
- NCT01709110
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,366 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Postmenopausal Osteoporosis
- Interventions
- Teriparatide, Risedronate, Placebo, Calcium, Vitamin D
- First posted
- 2012-10-17
- Last updated
- 2019-09-23
- Other registries' IDs
- eudract:2012-000123-41
- Results first posted
- 2018-01-23
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
| 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 | 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. |
| 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 | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants With New Vertebral Fractures | Baseline through 24 Months | 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. | Participants (with at least one event) | NUMBER |
| SECONDARY | Proportion of Participants With Pooled New and Worsening Vertebral Fractures | Baseline through 24 Months | 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. | Participants (with at least one event) | NUMBER |
| SECONDARY | Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures | Baseline through 24 Months | Full analysis set: all participants who received at least one dose of study drug and had evaluable data. | Participants (with at least one event) | NUMBER |
| SECONDARY | Proportion of Participants With Non-Vertebral Fragility Fractures | Baseline through 24 Months | Full analysis set: all participants who received at least one dose of study drug and had evaluable data. | Participants (with at least one event) | NUMBER |
| SECONDARY | Proportion of Participants With Major Non-Vertebral Fragility Fractures | Baseline through 24 Months | Full analysis set: all participants who received at least one dose of study drug and had evaluable data. | Participants (with at least one event) | NUMBER |
| SECONDARY | Proportion of Participants With New Moderate and/or Severe Vertebral Fractures | Baseline through 24 Months | 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. | Participants (with at least one event) | NUMBER |
| SECONDARY | Proportion of Participants With New Multiple (2 or More) Vertebral Fractures | Baseline through 24 Months | 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. | Participants (with at least one event) | NUMBER |
| SECONDARY | Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures | Baseline through 24 Months | Full analysis set: all participants who received at least one dose of study drug and had evaluable data. | Participants (with at least one event) | NUMBER |
| SECONDARY | Change From Baseline to 24 Months Endpoint in Height | Baseline, 24 Months | Full analysis set: all participants who received at least one dose of study drug and had evaluable data. | Centimeter (cm) | MEAN |
| SECONDARY | Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale | Baseline, 24 Months | Full analysis set: all participants who received at least one dose of study drug and had evaluable data. | units on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants With New Vertebral Fractures | Teriparatide | 28 | Participants (with at least one event) | ||
| Proportion of Participants With New Vertebral Fractures | Risedronate | 64 | Participants (with at least one event) | ||
| Proportion of Participants With Pooled New and Worsening Vertebral Fractures | Teriparatide | 31 | Participants (with at least one event) | ||
| Proportion of Participants With Pooled New and Worsening Vertebral Fractures | Risedronate | 69 | Participants (with at least one event) | ||
| Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures | Teriparatide | 30 | Participants (with at least one event) | ||
| Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures | Risedronate | 61 | Participants (with at least one event) | ||
| Proportion of Participants With Non-Vertebral Fragility Fractures | Teriparatide | 25 | Participants (with at least one event) | ||
| Proportion of Participants With Non-Vertebral Fragility Fractures | Risedronate | 38 | Participants (with at least one event) | ||
| Proportion of Participants With Major Non-Vertebral Fragility Fractures | Teriparatide | 18 | Participants (with at least one event) | ||
| Proportion of Participants With Major Non-Vertebral Fragility Fractures | Risedronate | 31 | Participants (with at least one event) |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Teriparatide | 683 | |
| Overall Study | STARTED | Risedronate | 683 | |
| Overall Study | Received at Least One Dose of Study Drug | Teriparatide | 680 | |
| Overall Study | Received at Least One Dose of Study Drug | Risedronate | 680 | |
| Overall Study | COMPLETED | Teriparatide | 498 | |
| Overall Study | COMPLETED | Risedronate | 515 | |
| Overall Study | NOT COMPLETED | Teriparatide | 185 | |
| Overall Study | NOT COMPLETED | Risedronate | 168 |
Source ClinicalTrials.gov
Adverse events452
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Teriparatide | 44 | 683 | 54 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Risedronate | 51 | 683 | 63 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Teriparatide | 73 | 683 | 77 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Risedronate | 79 | 683 | 89 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Teriparatide | 37 | 683 | 45 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Risedronate | 0 | 683 | 0 |
| serious | Coagulopathy | Blood and lymphatic system disorders | Teriparatide | 1 | 683 | 1 |
| serious | Coagulopathy | Blood and lymphatic system disorders | Risedronate | 0 | 683 | 0 |
| serious | Haemolytic anaemia | Blood and lymphatic system disorders | Teriparatide | 0 | 683 | 0 |
| serious | Haemolytic anaemia | Blood and lymphatic system disorders | Risedronate | 1 | 683 | 2 |
1 to 10 of 452Source ClinicalTrials.gov
See all 452 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Teriparatide | ||
| Total, all-cause mortality | Risedronate | ||
| Total, other adverse events | Teriparatide | 130 | 683 |
| Total, other adverse events | Risedronate | 130 | 683 |
| Total, serious adverse events | Teriparatide | 138 | 683 |
| Total, serious adverse events | Risedronate | 117 | 683 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Teriparatide vs Risedronate: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01709110
GET https://conductscience.org/api/trials/v1/NCT01709110/results?page=2