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

This study has been completed.
Sponsor:
Information provided by:
Acceleron Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00709540
First received: July 1, 2008
Last updated: December 8, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Biological: ACE-011 or placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Acceleron Pharma, Inc.:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of multiple, escalating doses of ACE-011 in healthy postmenopausal women. [ Time Frame: specified timepoints in the protocol ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To estimate the pharmacokinetic (PK) parameters of multiple, escalating doses of ACE-011 administered subcutaneously and to determine the effect of ACE-011 on bone mineral density (BMD) and biochemical markers of bone formation and resorption. [ Time Frame: at specified timepoints in the protocol ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single
10 subjects (8 active and 2 placebo)
Biological: ACE-011 or placebo
multiple administrations of ACE-011 given subcutaneously once per month for 3 months (4 administrations total)

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

    • 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.
  11. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709540

Locations
United States, California
West Coast Clinical Trials
Cypress, California, United States, 90630
Sponsors and Collaborators
Acceleron Pharma, Inc.
Investigators
Principal Investigator: Michelle Ababa, MD West Coast Clinical Trials
  More Information

No publications provided

Responsible Party: Matthew L Sherman MD, Acceleron Pharma Inc.
ClinicalTrials.gov Identifier: NCT00709540     History of Changes
Other Study ID Numbers: A011-02
Study First Received: July 1, 2008
Last Updated: December 8, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 20, 2014