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Study Complete
Sponsor ID
20090378

A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women

Sponsor ID
20090378
Clinicaltrials.gov ID
NCT01101061
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The main purpose of this study is to assess the safety, tolerability and potential immune response to romosozumab following single subcutaneous (SC; injection under the skin) dose administration in healthy postmenopausal Japanese and non-Japanese women.

Additional Study Details

Phase
Phase 1
Product
AMG 785
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
31
Additional Study Details

Protocol Summary

Primary Outcome Measures

The number (percent) of subjects experiencing clinically significant changes in vital signs, physical exams, laboratory safety tests, and ECGs

Timeframe: A maximum of 85 days following investigational product administration.

The number (percent) of subjects who develop anti-AMG 785 antibodies

Timeframe: A maximum of 85 days following investigational product administration.

The number (percent) of subjects reporting treatment-emergent adverse events

Timeframe: A maximum of 85 days following investigational product administration.

Secondary Outcome Measures

Pharmacokinetic (PK) and pharmacodynamic (PD) parameters [procollagen type 1 N-terminal propeptide (P1NP), serum C-telopeptide (sCTX) and sclerostin] following single subcutaneous (SC) dose administration in Japanese and non-Japanese women

Timeframe: A maximum of 85 days following investigational product administration.

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
45 - 70 Years
Condition
  • Bone Pain
    • Sex
    Assigned Female at Birth
    Trial Dates
    May 2010 - Nov 2010
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Japanese subjects must be first (4 grandparents, biologic parents and subject born in Japan), second (4 grandparents and biological parents born in Japan) or third (4 grandparents born in Japan) generation Japanese - Body mass index ≤ 25 kg/m², inclusive at screening - Postmenopausal females defined as 12 continuous months of spontaneous amenorrhea confirmed by a serum follicle-stimulating hormone (FSH) result > 40 mIU/mL, or 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy) as documented in medical history (verified with an operative note, if available)
    Exclusion Criteria:
    - Osteoporosis, as defined by bone mineral density (BMD) T-scores of the lumbar spine (L1-L4) or total evaluable vertebrae (if fewer than L1-L4); or femoral neck ≤ -2.5 - History of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis; - Diagnosed with any condition that will affect bone metabolism