Teriparatide and Risedronate in the Treatment of Patients With Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures

CompletadoFase 4ClinicalTrials.gov

ID: NCT01709110Tipo: INTERVENTIONALInicio: 1 de oct de 2012Fin estimado: 1 de jul de 2016

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 45 YearsSexo: FEMALE

Criterios de inclusión

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

Criterios de exclusión

History of nephro- or urolithiasis
Significant impairment of hepatic or renal function
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
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

Intervenciones

drug

Teriparatide

Administered SC

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

Ubicaciones

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Buenos Aires, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Caba, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Mar del Plata, Argentina

Patrocinadores

PrincipalEli Lilly and Company

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

Teriparatide and Risedronate in the Treatment of Patients... | EligiMed