Osteoporosis
Conditions
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.
Interventions
BIOLOGICALACE-011 or placebo
multiple administrations of ACE-011 given subcutaneously once per month for 3 months (4 administrations total)
Sponsors
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of multiple, escalating doses of ACE-011 in healthy postmenopausal women. | specified timepoints in the protocol |
Secondary
| Measure | Time frame |
|---|---|
| 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. | at specified timepoints in the protocol |
Countries
United States
Outcome results
None listed