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Search / Trial NCT01709110

VERtebral Fracture Treatment Comparisons in Osteoporotic Women

Launched by ELI LILLY AND COMPANY · Oct 16, 2012

Trial Information

Current as of July 21, 2025

Completed

Keywords

Bone Loss Vertebral Fractures

ClinConnect Summary

No description provided

Gender

FEMALE

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

About Eli Lilly And Company

Eli Lilly and Company is a global healthcare leader dedicated to creating innovative medicines that improve patient outcomes across a range of therapeutic areas, including diabetes, oncology, immunology, and neurodegenerative diseases. With a rich history of scientific research and a commitment to advancing healthcare, Lilly invests significantly in clinical trials to develop new treatments and enhance existing therapies. The company prioritizes patient safety and ethical standards in its clinical research, fostering collaboration with healthcare professionals and stakeholders to ensure the delivery of high-quality, evidence-based solutions that address unmet medical needs worldwide.

Locations

Firenze, , Italy

Torino, , Italy

San Juan, , Puerto Rico

Pittsburgh, Pennsylvania, United States

Dallas, Texas, United States

Vancouver, British Columbia, Canada

Leipzig, , Germany

Birmingham, Alabama, United States

Bethesda, Maryland, United States

Indianapolis, Indiana, United States

Padova, , Italy

Asheville, North Carolina, United States

Sabadell, , Spain

Topeka, Kansas, United States

Omaha, Nebraska, United States

Eger, , Hungary

Gent, , Belgium

Genk, , Belgium

Leuven, , Belgium

Gilly, , Belgium

Evansville, Indiana, United States

Rome, , Italy

Barcelona, , Spain

Toulouse, , France

Madrid, , Spain

Concord, California, United States

Fresno, California, United States

Alcira, , Spain

Detroit, Michigan, United States

Albuquerque, New Mexico, United States

Graz, , Austria

Montreal, Quebec, Canada

Prague, , Czechia

Laguna Hills, California, United States

Gainesville, Georgia, United States

Spokane, Washington, United States

Madison, Wisconsin, United States

Rio De Janeiro, , Brazil

Hamilton, Ontario, Canada

Sainte Foy, Quebec, Canada

Trois Rivieres, Quebec, Canada

Saskatoon, Saskatchewan, Canada

Frankfurt, , Germany

Valeggio Sul Mincio, , Italy

Saint Etienne, , France

Brussels, , Belgium

Caen, , France

Orbassano, , Italy

Bend, Oregon, United States

Toronto, Ontario, Canada

Patras, , Greece

Halifax, Nova Scotia, Canada

Lancaster, California, United States

Hamburg, , Germany

Magdeburg, , Germany

Kifissia, , Greece

Brasilia, , Brazil

Kaposvar, , Hungary

Lakewood, Colorado, United States

Orlando, Florida, United States

Tustin, California, United States

Danbury, Connecticut, United States

Greensboro, North Carolina, United States

Seattle, Washington, United States

Duncansville, Pennsylvania, United States

Elblag, , Poland

Fargo, North Dakota, United States

Klatovy, , Czechia

Orleans, , France

Buenos Aires, , Argentina

Debrecen, , Hungary

Linz, , Austria

Szeged, , Hungary

Kelowna, British Columbia, Canada

Athens, , Greece

Freehold, New Jersey, United States

Clifton, New Jersey, United States

Thessaloniki, , Greece

Warsaw, , Poland

Wyomissing, Pennsylvania, United States

Merksem, , Belgium

Marburg, , Germany

Valencia, , Spain

Uherske Hradiste, , Czechia

Bialystok, , Poland

Poznan, , Poland

Dresden, , Germany

Lublin, , Poland

Caba, , Argentina

Mar Del Plata, , Argentina

Hohenems, , Austria

Vienna, , Austria

Laken, , Belgium

Liège, , Belgium

Mons, , Belgium

São Paulo, , Brazil

Ceske Budejovice, , Czechia

La Crau, , France

Lyon, , France

Budapest, , Hungary

Genova Nervi, , Italy

Swidnik, , Poland

Cadiz, , Spain

Patients applied

0 patients applied

Trial Officials

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)

Study Director

Eli Lilly and Company

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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