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NCT Number: NCT02016716

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

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

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

55 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Brno, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

Romosozumab 90 mg/mL

Drug

Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS).

Other names: AMG 785, EVENITY™

Placebo 90 mg/mL

Drug

Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS.

Romosozumab 70 mg/mL

Drug

Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS.

Other names: AMG 785, EVENITY™

Placebo 70 mg/mL

Drug

Placebo administered as 3 SC injections with the 1.0 mL glass PFS.

Primary outcomes

  1. Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine

    Time frame: Baseline and month 6

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

Secondary outcomes

  1. Percent Change From Baseline in Total Hip BMD

    Time frame: Baseline and month 6

    Total hip BMD was measured using DXA. The analysis was based on an ANCOVA model adjusted for treatment and baseline total hip BMD T-score.

  2. Percent Change From Baseline in Femoral Neck BMD

    Time frame: Baseline and month 6

    Femoral neck BMD was measured using DXA. The analysis was based on an ANCOVA model adjusted for treatment and baseline femoral neck BMD T-score.

  3. Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP)

    Time frame: Baseline, month 1, month 3, and month 6

  4. Percent Change From Baseline in Serum C-Telopeptide (CTX)

    Time frame: Baseline, month 1, month 3, and month 6

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Multicenter, Randomized, Multiple-dose Phase 3 Study to Evaluate the Noninferiority of Romosozumab at a 90 mg/mL Concentration Compared With a 70 mg/mL Concentration in Postmenopausal Women With Osteoporosis

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 20, 2013
Registry last updated
Nov 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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