A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis

Last updated: October 11, 2018
Sponsor: Amgen
Overall Status: Completed

Phase

3

Condition

Post-menopausal Osteopenia

Osteoporosis

Treatment

N/A

Clinical Study ID

NCT02016716
20120156
2013-000434-35
  • Ages 55-90
  • Female

Study Summary

The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.

Eligibility Criteria

Inclusion

Inclusion Criteria: Postmenopausal women with osteoporosis at high risk for fracture defined as

  • BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck AND

  • a history of fragility fracture or at least 2 other risk factors

Exclusion

Exclusion Criteria:

  • BMD T score < -3.50 at the total hip or femoral neck.

  • History of hip fracture.

  • History of metabolic or bone disease (except osteoporosis).

  • Use of agents affecting bone metabolism.

  • Vitamin D insufficiency.

  • History of solid organ or bone marrow transplants.

  • Hyper- or hypocalcemia.

  • Hyper- or hypothyroidism.

  • Hyper- or hypoparathyroidism.

Study Design

Total Participants: 294
Study Start date:
December 03, 2013
Estimated Completion Date:
December 08, 2014

Study Description

Upon confirmation of eligibility, participants were randomized in a 22:5:22:5 ratio to the following treatment groups:

  • Romosozumab 90 mg/mL

  • Placebo 90 mg/mL

  • Romosozumab 70 mg/mL

  • Placebo 70 mg/mL

After completing a 6-month treatment period, participants entered a 3-month follow-up period with an end of study (EOS) at month 9.

For the analysis of efficacy endpoints, the 2 placebo groups were combined into a single placebo group. For safety analyses, the data for placebo were presented separately for each group.

Connect with a study center

  • Research Site

    Brno, 602 00
    Czechia

    Site Not Available

  • Research Site

    Klatovy, 339 01
    Czechia

    Site Not Available

  • Research Site

    Uherske Hradiste, 686 01
    Czechia

    Site Not Available

  • Research Site

    Gdynia, 81-384
    Poland

    Site Not Available

  • Research Site

    Gliwice, 44-100
    Poland

    Site Not Available

  • Research Site

    Katowice, 40-040
    Poland

    Site Not Available

  • Research Site

    Kraków, 31-501
    Poland

    Site Not Available

  • Research Site

    Swidnik, 21-040
    Poland

    Site Not Available

  • Research Site

    Warszawa, 01-192
    Poland

    Site Not Available

  • Research Site

    Wroclaw, 50-088
    Poland

    Site Not Available

  • Research Site

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Research Site

    Bethesda, Maryland 20817
    United States

    Site Not Available

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