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NCT02157948 · ClinicalTrials.gov registry record · Phase 3

A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

A Phase 3 study, sponsored by Amgen.

Completed
Registry status
Phase 3
Development phase
394
Enrollment target

NCT02157948: Completed Phase 3 study, sponsored by Amgen.

NCT02157948 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 394 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02157948, a Phase 3 study, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 3
Development phase
394 participants
Enrollment target

Study Summary

This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.

Primary Outcome

Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Interventions

  • DRUG Denosumab (CP2)
  • DRUG Denosumab (CP4)

Trial Details

FieldValue
Enrollment Target 394 participants
Start Date 2014-05
Est. Completion 2015-07
Phase Phase 3
Amgen

558 total trials

What the finished NCT02157948 record still lists

NCT02157948 is an interventional study that assigns participants to a tested intervention. The registered 394 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower).

The record links to 0 conditions, and to 2 interventions - of which Denosumab (CP2) is the first listed.

NCT02157948 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02157948 about?

NCT02157948 is a clinical study titled "A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis". This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.

What is the current status of trial NCT02157948?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 394 participants. The study started on 2014-05. Estimated completion is 2015-07.

What interventions are being tested in trial NCT02157948?

The interventions under investigation include: Denosumab (CP2) (DRUG), Denosumab (CP4) (DRUG).

Who is sponsoring clinical trial NCT02157948?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02157948's enrollment target sits among peer trials

394 967th of 2000 higher than 1,034 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02157948, the US trial registry maintained by the National Library of Medicine. NCT02157948 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.