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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-14

Study Completion Date

2008-12-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Postmenopausal Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) for 3 months.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered by subcutaneous injection

Romosozumab

Participants were randomized to receive romosozumab administered by subcutaneous injection at doses of 1 mg/kg Q2W, 2 mg/kg Q4W, 2 mg/kg Q2W, or 3 mg/kg Q4W for 3 months.

Group Type EXPERIMENTAL

Romosozumab

Intervention Type DRUG

Administered by subcutaneous injection

Interventions

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Romosozumab

Administered by subcutaneous injection

Intervention Type DRUG

Placebo

Administered by subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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AMG 785 EVENITY™

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes