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NCT00709540 · ClinicalTrials.gov registry record · Phase 1

A Safety, Tolerability and Pharmacodynamics Study of ACE-011 (ActRIIA-IgG1) in Healthy Postmenopausal Women

A Phase 1 study of Osteoporosis, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ U.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target
1
Study location

NCT00709540 is a Phase 1 study of Osteoporosis that has completed, run by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ U. The registered enrollment target is 40 participants, below the 1,545-participant average among 84 other Osteoporosis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00709540, a Phase 1 study of Osteoporosis, has completed, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ U.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

This is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACE-011 in healthy postmenopausal women.

Conditions Studied

Interventions

  • BIOLOGICAL ACE-011 or placebo

Study Locations (1)

California

  • West Coast Clinical Trials - Cypress

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2008-01
Est. Completion 2008-11
Phase Phase 1

What the Registry Record Tells You About NCT00709540

The ClinicalTrials.gov registry entry for NCT00709540 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,545-participant average among 84 other Osteoporosis trials with a reported enrollment target (97% lower). The listed sponsor is Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ U, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Osteoporosis appearing as the primary indexed condition, and to 1 intervention - of which ACE-011 or placebo is the first listed.

NCT00709540 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT00709540 about?

NCT00709540 is a clinical study titled "A Safety, Tolerability and Pharmacodynamics Study of ACE-011 (ActRIIA-IgG1) in Healthy Postmenopausal Women". This is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACE-011 in healthy postmenopausal women.

What is the current status of trial NCT00709540?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2008-01. Estimated completion is 2008-11.

What conditions does trial NCT00709540 study?

This clinical trial studies the following conditions: Osteoporosis.

What interventions are being tested in trial NCT00709540?

The interventions under investigation include: ACE-011 or placebo (BIOLOGICAL).

Who is sponsoring clinical trial NCT00709540?

This trial is sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ U, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00709540 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.