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Study Complete
Sponsor ID
20060221

A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785)

Sponsor ID
20060221
Clinicaltrials.gov ID
NCT01825785
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The primary objective of this study was to assess the safety, tolerability, and immunogenicity potential of romosozumab following multiple subcutaneous (SC) administrations in healthy men and postmenopausal women with low bone mass.

Additional Study Details

Phase
Phase 1
Product
AMG 785
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
48
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number (percent) of subjects reporting treatment-emergent adverse events

Timeframe: 169 days following initial investigational product administration

Number (percent) of subjects who experienced clinically significant changes in safety laboratory tests, physical examinations, vital signs, or electrocardiograms

Timeframe: 169 days following initial investigational product administration

Number (percent) of subjects who developed antibodies to AMG 785

Timeframe: 169 days following initial investigational product administration

Secondary Outcome Measures

Area under the serum concentration-time curve (AUC), maximum observed concentration (Cmax), and time of maximum drug concentration (Tmax)

Timeframe: 169 days following initial investigational product administration

Bone mineral density as assessed by dual energy X-ray absorptiometry, serum procollagen type 1 N-terminal propeptide, osteocalcin, bone-specific alkaline phosphatase, serum CTX, intact Parathyroid Hormone, serum and ionized calcium, and sclerostin levels

Timeframe: 169 days following initial investigational product administration

Study Documents

Study Synopsis
Available Language(s): English
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Locations

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Study Info
Age
N/A
Condition
  • Osteoporosis
    • Show more
  • Bone Pain
    • Sex
    N/A
    Trial Dates
    Nov 2007 - Dec 2008
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Healthy males and females between 45 to 80 years of age - Postmenopausal females - Low bone mineral density, defined by bone mineral density (BMD) T-scores between -1.0 and -2.5, inclusive, for the lumbar spine [L1-L4] or total evaluable vertebrae [if fewer than L1-L4] or total hip) - 25-hydroxyvitamin D ≥ 20 ng/mL - Weight ≤ 98 kg (216 lb) and/or height ≤ 196 cm (77 in)
    Exclusion Criteria:
    - Osteoporosis defined by bone mineral density (BMD) T-scores < -2.5 for the lumbar spine (L1-L4) or total evaluable vertebrae (if fewer than L1-L4) or total hip - Diagnosed with any condition that would affect bone metabolism - Previous exposure to AMG 785