VERtebral Fracture Treatment Comparisons in Osteoporotic Women - Full Text View

Purpose

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	Intervention	Phase
Postmenopausal Osteoporosis	Drug: Teriparatide Drug: Risedronate Drug: Placebo Drug: Calcium Drug: Vitamin D	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Fractures Osteoporosis Spine Injuries and Disorders Vitamin D

Drug Information available for: Calcium Gluconate Vitamin D Teriparatide Teriparatide acetate Risedronate sodium

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Proportion of Participants with New Vertebral Fractures [ Time Frame: Baseline through 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of Participants with Pooled New and Worsening Vertebral Fractures [ Time Frame: Baseline through 24 Months ] [ Designated as safety issue: No ]
Proportion of Participants with Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures [ Time Frame: Baseline through 24 Months ] [ Designated as safety issue: No ]
Proportion of Participants with Non-Vertebral Fragility Fractures [ Time Frame: Baseline through 24 Months ] [ Designated as safety issue: No ]
Proportion of Participants with Major Non-Vertebral Fragility Fractures [ Time Frame: Baseline through 24 Months ] [ Designated as safety issue: No ]
Proportion of Participants with New Moderate and/or Severe Vertebral Fractures [ Time Frame: Baseline through 24 Months ] [ Designated as safety issue: No ]
Proportion of Participants with New Multiple (2 or more) Vertebral Fractures [ Time Frame: Baseline through 24 Months ] [ Designated as safety issue: No ]
Proportion of Participants with Pooled Fragility and Traumatic Non-Vertebral Fractures [ Time Frame: Baseline through 24 Months ] [ Designated as safety issue: No ]
Change from Baseline to 24 Months Endpoint in Height [ Time Frame: Baseline, 24 Months ] [ Designated as safety issue: No ]
Change from Baseline to 24 Month Endpoint in Back Pain using an 11-point Numerical Pain Rating Scale [ Time Frame: Baseline, 24 Months ] [ Designated as safety issue: No ]
Change from Baseline to 24 Month Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] [ Time Frame: Baseline, 24 Months ] [ Designated as safety issue: No ]


Enrollment:	1327
Study Start Date:	October 2012
Study Completion Date:	July 2016
Primary Completion Date:	July 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: LY333334 Forteo Forsteo 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

Eligibility


Ages Eligible for Study:	45 Years and older (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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) are 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709110

Show 103 Study Locations

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

More Information


Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01709110 History of Changes
Other Study ID Numbers:	14536 B3D-EW-GHDW 2012-000123-41
Study First Received:	October 16, 2012
Last Updated:	July 14, 2016
Health Authority:	United States: Food and Drug Administration Austria: Federal Office for Safety in Health Care Germany: Federal Institute for Drugs and Medical Devices France: Agence Nationale de Sécurité du Médicament et des produits de santé Italy: Ministry of Health Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines Spain: Agencia Española de Medicamentos y Productos Sanitarios Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Belgium: Federal Agency for Medicinal Products and Health Products Czech Republic: State Institute for Drug Control Greece: National Organization of Medicines Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Brazil: National Health Surveillance Agency Canada: Health Canada

Keywords provided by Eli Lilly and Company:


Bone Loss Vertebral fractures

Additional relevant MeSH terms:


Osteoporosis Osteoporosis, Postmenopausal Spinal Fractures Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Spinal Injuries Back Injuries Wounds and Injuries Fractures, Bone Vitamins Vitamin D	Ergocalciferols Calcium, Dietary Risedronate Sodium Etidronic Acid Teriparatide Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 23, 2016

VERtebral Fracture Treatment Comparisons in Osteoporotic Women (VERO)