Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis

Last updated: November 18, 2020
Sponsor: Radius Health, Inc.
Overall Status: Completed

Phase

3

Condition

Osteoporosis

Post-menopausal Osteopenia

Treatment

N/A

Clinical Study ID

NCT01657162
BA058-05-005
ACTIVExtend Trial
2012-002216-10
  • Ages 50-85
  • Female

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The participant was enrolled, randomized to either the abaloparatide-SC (BA058) orplacebo arm, and successfully completed Study BA058-05-003 (NCT02653417).
  2. The participant was no more than 40 days from End-of-Treatment (Month 18) in StudyBA058-05-003 (NCT02653417).

Exclusion

Exclusion Criteria:

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 Participants who were withdrawn from Study BA058-05-003 (NCT02653417) for any reason.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

Study Design

Total Participants: 1139
Study Start date:
November 20, 2012
Estimated Completion Date:
October 03, 2016

Study Description

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.

Connect with a study center

  • Buenos Aires,
    Argentina

    Site Not Available

  • Brasilia,
    Brazil

    Site Not Available

  • Curitiba,
    Brazil

    Site Not Available

  • Rio de Janeiro,
    Brazil

    Site Not Available

  • empty

    Sao Paolo,
    Brazil

    Site Not Available

  • São Paulo,
    Brazil

    Site Not Available

  • Vitoria,
    Brazil

    Site Not Available

  • empty

    Prague,
    Czech Republic

    Site Not Available

  • Brno,
    Czechia

    Site Not Available

  • Pardubice,
    Czechia

    Site Not Available

  • Vinohrady,
    Czechia

    Site Not Available

  • Aalborg,
    Denmark

    Site Not Available

  • Ballerup,
    Denmark

    Site Not Available

  • empty

    Vejie,
    Denmark

    Site Not Available

  • Vejle,
    Denmark

    Site Not Available

  • Tallinn,
    Estonia

    Site Not Available

  • Tartu,
    Estonia

    Site Not Available

  • Hong Kong,
    Hong Kong

    Site Not Available

  • Vilnius,
    Lithuania

    Site Not Available

  • Bialystok,
    Poland

    Site Not Available

  • empty

    Katowice,
    Poland

    Site Not Available

  • Kielce,
    Poland

    Site Not Available

  • Lodz,
    Poland

    Site Not Available

  • Warsaw,
    Poland

    Site Not Available

  • Zgierz,
    Poland

    Site Not Available

  • Bucharest,
    Romania

    Site Not Available

  • Lakewood, Colorado
    United States

    Site Not Available

  • Hialeah, Florida
    United States

    Site Not Available

  • empty

    Miami, Florida
    United States

    Site Not Available

  • empty

    NMiami, Florida
    United States

    Site Not Available

  • empty

    Atlanta, Georgia
    United States

    Site Not Available

  • Bethesda, Maryland
    United States

    Site Not Available

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