An Extension Study to Evaluate 24 Months of Standard-of-C... | EligiMed

An Extension Study to Evaluate 24 Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003

CompletadoFase 3ClinicalTrials.gov

ID: NCT01657162RENIS: IS000403Tipo: INTERVENTIONALInicio: 20 de nov de 2012Fin estimado: 3 de oct de 2016

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417).

Descripción detallada

To assess the long-term effect of the anabolic drug, abaloparatide-subcutaneous (SC) versus placebo in the prevention of bone fracture after cessation of treatment. Participants who completed the 18-month Double-Blind BA058-05-003 (ACTIVE) study (NCT02653417), after receiving abaloparatide-SC or placebo, were enrolled in this extension study to receive 70 mg of alendronate (bisphosphonate) weekly for an additional 24 months. Complete details for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.

Elegibilidad

Edad mínima: 50 YearsEdad máxima: 85 YearsSexo: FEMALE

Criterios de inclusión

The participant was enrolled, randomized to either the abaloparatide-SC (BA058) or placebo arm, and successfully completed Study BA058-05-003 (NCT02653417).
The participant was no more than 40 days from End-of-Treatment (Month 18) in Study BA058-05-003 (NCT02653417).

Criterios de exclusión

Participants who were withdrawn from Study BA058-05-003 (NCT02653417) for any reason.
Participants who experienced a treatment-related serious adverse event (SAE) during Study BA058-05-003 (NCT02653417).

Intervenciones

drug

Alendronate

Alendronate is a bisphosphonate drug that prevents bone resorption by osteoclast and is used for the treatment of osteoporosis.

Ubicaciones

Buenos Aires, Argentina

Patrocinadores

PrincipalRadius Health, Inc.

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