Clinical trial NCT00709540: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: To evaluate the safety and tolerability of multiple, escalating doses of ACE-011 in healthy postmenopausal women.
timeFrame: specified timepoints in the protocol
Secondary outcomes:
measure: 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.
timeFrame: at specified timepoints in the protocol
Other outcomes:
Locations:
city: Cypress
country: United States
facility: West Coast Clinical Trials
state: California
Study officials:
affiliation: West Coast Clinical Trials
name: Michelle Ababa, MD
role: PRINCIPAL_INVESTIGATOR
References: