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Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis

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Amgen

Status and phase

Completed
Phase 2

Conditions

Postmenopausal Osteoporosis (PMO)

Treatments

Drug: Romosozumab
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01992159
20101291

Details and patient eligibility

About

The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.

Enrollment

252 patients

Sex

Female

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ambulatory, postmenopausal Japanese women with osteoporosis (defined as bone mineral density T-score of ≤ -4.00 at the lumbar spine or BMD T-score of ≤ -3.50 at the total hip, or femoral neck)

Exclusion criteria

  • Severe osteoporosis
  • Use of agents affecting bone metabolism
  • History of metabolic or bone disease (except osteoporosis)
  • Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
  • Current hyper- or hypocalcemia
  • Current, uncontrolled hyper- or hypothyroidism
  • Current, uncontrolled hyper- or hypoparathyroidism

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

252 participants in 4 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
Treatment:
Drug: Placebo
Romosozumab 70 mg
Experimental group
Description:
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Treatment:
Drug: Romosozumab
Romosozumab 140 mg
Experimental group
Description:
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Treatment:
Drug: Romosozumab
Romosozumab 210 mg
Experimental group
Description:
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Treatment:
Drug: Romosozumab

Trial contacts and locations

27

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Data sourced from clinicaltrials.gov

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