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
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 April 17, 2014