A Safety, Tolerability and Pharmacodynamics Study of ACE-011 (ActRIIA-IgG1) in Healthy Postmenopausal Women
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ACE-011 or placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Sites / Locations
- West Coast Clinical Trials
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single
Arm Description
10 subjects (8 active and 2 placebo)
Outcomes
Primary Outcome Measures
To evaluate the safety and tolerability of multiple, escalating doses of ACE-011 in healthy postmenopausal women.
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.
Full Information
NCT ID
NCT00709540
First Posted
July 1, 2008
Last Updated
July 15, 2021
Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
1. Study Identification
Unique Protocol Identification Number
NCT00709540
Brief Title
A Safety, Tolerability and Pharmacodynamics Study of ACE-011 (ActRIIA-IgG1) in Healthy Postmenopausal Women
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single
Arm Type
Experimental
Arm Description
10 subjects (8 active and 2 placebo)
Intervention Type
Biological
Intervention Name(s)
ACE-011 or placebo
Intervention Description
multiple administrations of ACE-011 given subcutaneously once per month for 3 months (4 administrations total)
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of multiple, escalating doses of ACE-011 in healthy postmenopausal women.
Time Frame
specified timepoints in the protocol
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Ababa, MD
Organizational Affiliation
West Coast Clinical Trials
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Coast Clinical Trials
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety, Tolerability and Pharmacodynamics Study of ACE-011 (ActRIIA-IgG1) in Healthy Postmenopausal Women
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