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

Completed · Phase 1 · Has a placebo group

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT00709540

Run by

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

People needed

40

Starts

2008-01-01

Expected to finish

2008-11-01

Last updated by the study team

2021-07-21

Who can join

Age: 45 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subject is a postmenopausal woman, 45-85 years old (inclusive).
• 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.
• 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.
• Subject has a body mass index (BMI) of ≥ 18.5 to < 30.
• Subject must give written informed consent. If required by local law, candidates must also authorize the release and use of protected health information (PHI).

You may not qualify if…

• Subject has a history of clinically significant major disease (as determined by the Investigator).
• Subject has a history of hyperparathyroidism, hypoparathyroidism, hypocalcemia, rheumatoid arthritis, myeloproliferative disorder, gout, Paget's disease of the bone, or osteomalacia.
• 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.
• Subject has a history of opportunistic infection, or has had a serious local or systemic infection within 3 months prior to screening.
• Subject has a history of severe allergic or anaphylactic reactions.
• Subject had major surgery within the previous 3 months.
• 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.
• Subject consumed any alcohol within 72 hours prior to dosing.
• 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.
• Subject has taken any of the following bone active medications:
• Teriparatide at any time in their lifetime.
• Fluoride therapy for more than 3 months during the previous 2 years.
• Estrogen, androgen, anabolic steroids, corticosteroids (excluding inhaled, topical or local injections for joint pain), calcitonin, or other bone active drugs (e.g. selective estrogen receptor modulators) within the 4 months prior to screening.
• Bisphosphonates:
• If treated for more than 6 months at any time in their lifetime.
• If treated for 3 to 6 months within 2 years of screening.
• If treated for less than 3 months within 6 months of screening.
• Subjects with chronic stable diseases including migraines, hypertension, hyperthyroid disorder, hypothyroid disorder, gastroesophageal reflux disease, or mild depression/anxiety will be excluded unless the investigator does not have safety or compliance concerns at study entry.

Where it is running

• West Coast Clinical Trials — Cypress, California, United States

Full record on ClinicalTrials.gov

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