Phase 4
Completed N=1,366
VERtebral Fracture Treatment Comparisons in Osteoporotic Women
Source: ClinicalTrials.gov NCT01709110 ↗Enrolled (actual)
1,366
Serious AEs
18.7%
Results posted
Jan 2018
Primary outcomePrimary: Proportion of Participants With New Vertebral Fractures — 28; 64 Participants (with at least one event) — p=0.000094
◆ Published Evidence
Highly cited
581citations · ~73 / year
Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial.
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.
Linked Publications (5)
-
Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial.
-
Effects of Teriparatide Compared with Risedronate on the Risk of Fractures in Subgroups of Postmenopausal Women with Severe Osteoporosis: The VERO Trial.
-
Efficacy of teriparatide compared with risedronate on FRAX<sup>®</sup>-defined major osteoporotic fractures: results of the VERO clinical trial.
-
Serum 25-hydroxy-vitamin D and the risk of fractures in the teriparatide versus risedronate VERO clinical trial.
-
Distribution of Prevalent and Incident Vertebral Fractures and Their Association with Bone Mineral Density in Postmenopausal Women in the Teriparatide Versus Risedronate VERO Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With New Vertebral Fractures |
28; 64 | 0.000094 sig |
| SECONDARY Proportion of Participants With Pooled New and Worsening Vertebral Fractures |
31; 69 | 0.000075 sig |
| SECONDARY Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures |
30; 61 | 0.000869 sig |
| SECONDARY Proportion of Participants With Non-Vertebral Fragility Fractures |
25; 38 | 0.099023 |
| SECONDARY Proportion of Participants With Major Non-Vertebral Fragility Fractures |
18; 31 | 0.062432 |
| SECONDARY Proportion of Participants With New Moderate and/or Severe Vertebral Fractures |
26; 63 | <0.001 sig |
| SECONDARY Proportion of Participants With New Multiple (2 or More) Vertebral Fractures |
2; 12 | 0.007 sig |
| SECONDARY Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures |
40; 57 | 0.078 |
| SECONDARY Change From Baseline to 24 Months Endpoint in Height |
154.7; 155.0; 154.3; 154.5 | 0.093 |
| SECONDARY Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale |
4.5; 4.5; 3.4; 3.4 | 0.585 |
| SECONDARY Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK) |
0.59; 0.62; 0.65; 0.68 | 0.757 |
| SECONDARY Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US) |
0.70; 0.72; 0.74; 0.76 | 0.694 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01709110) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.