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A Safety, Tolerability and Pharmacodynamics Study of ACE-011 (ActRIIA-IgG1) in Healthy Postmenopausal Women | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacodynamics of ACE-011 (ActRIIA-IgG1) in Healthy Postmenopausal Women

NCT00709540•Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

View on ClinicalTrials.gov

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.

Eligibility

Age

45 - 85 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Subject is a postmenopausal woman, 45-85 years old (inclusive).
•2. Subject has had 12 months of spontaneous amenorrhea, OR 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels \>40 IU/L OR is 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
•3. Subject is taking at least 500 mg of calcium supplement and 400 IU of vitamin D daily and has been following this regimen for at least 4 weeks prior to the first dose of study drug administration.
•4. Subject has a body mass index (BMI) of ≥ 18.5 to \< 30.
•5. Subject must give written informed consent. If required by local law, candidates must also authorize the release and use of protected health information (PHI).

Exclusion Criteria

•1. Subject has a history of clinically significant major disease (as determined by the Investigator).
•2. Subject has a history of hyperparathyroidism, hypoparathyroidism, hypocalcemia, rheumatoid arthritis, myeloproliferative disorder, gout, Paget's disease of the bone, or osteomalacia.
•3. Subject has had a long bone fracture within the past 6 months prior to enrollment, or an osteoporosis-related fracture within the previous 2 years.
•4. Subject has a history of opportunistic infection, or has had a serious local or systemic infection within 3 months prior to screening.
•5. Subject has a history of severe allergic or anaphylactic reactions.
•6. Subject had major surgery within the previous 3 months.
•7. Subject has a history of drug or alcohol abuse, or tests positive in a drug and alcohol screen at screening or on Day 1 prior to dosing.
•8. Subject consumed any alcohol within 72 hours prior to dosing.
•9. Subject gave a blood donation (one unit or more) within 1 month prior to dosing, or plans to give a blood donation during the course of the study.
•10. Subject has taken any of the following bone active medications:
+8 more criteria

Locations (1)

West Coast Clinical Trials

Cypress, California, United States

Key Dates

Start Date

January 1, 2008

Primary Completion Date

November 1, 2008

Completion Date

November 1, 2008

Last Updated

July 21, 2021

Enrollment

ACTUAL participants

Conditions

Osteoporosis

Interventions

ACE-011 or placebo

BIOLOGICAL

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

NCT06731608

OsteoporosisLower Limb Fracture

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RECRUITINGPHASE4

Step-down Therapy After Long-term Osteoporosis Treatment

NCT07281586

Osteoporosis

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RECRUITING

Smart Wearable Device (gaitQ): Walk Better Project

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 21, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

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