Status:
COMPLETED
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785)
Lead Sponsor:
Amgen
Conditions:
Postmenopausal
Osteopenia
Eligibility:
All Genders
45-80 years
Phase:
PHASE1
Brief Summary
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 postmeno...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 14 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01825785
Start Date
November 14 2007
End Date
December 2 2008
Last Update
August 30 2023
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