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

Amgen

Status and phase: Completed; Phase 1

Conditions: Osteopenia; Postmenopausal

Treatments: Drug: Romosozumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01825785

20060221

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Romosozumab

Experimental group

Description:

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.

Treatment:

Drug: Romosozumab