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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709540
• Other study ID #: A011-02
• Status: Completed
• Phase: Phase 1
• Start date: January 2008
• Est. completion date: November 2008

Study information

• Verified date: July 2021
• Source: Acceleron Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Biological:
• ACE-011 or placebo
multiple administrations of ACE-011 given subcutaneously once per month for 3 months (4 administrations total)

Locations

Country	Name	City	State
United States	West Coast Clinical Trials	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Acceleron Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of multiple, escalating doses of ACE-011 in healthy postmenopausal women.		specified timepoints in the protocol
Secondary	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