Phase 4 N=1,366 Randomized Quadruple-blind Treatment

VERtebral Fracture Treatment Comparisons in Osteoporotic Women

Postmenopausal Osteoporosis

Bottom Line

View on ClinicalTrials.gov: NCT01709110 ↗

Enrolled (actual)

1,366

Serious AEs

18.7%

Results posted

Jan 2018

Primary outcome: Primary: Proportion of Participants With New Vertebral Fractures — 28; 64 Participants (with at least one event) — p=0.000094

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Teriparatide (Drug); Risedronate (Drug); Placebo (Drug); Calcium (Drug); Vitamin D (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: Female
Sponsor: Eli Lilly and Company
Primary completion: Jul 2016

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

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01709110). 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.