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A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis

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Amgen

Status and phase

Completed
Phase 3

Conditions

Osteoporosis

Treatments

Drug: Denosumab
Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00089791
20030216

Details and patient eligibility

About

This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.

Enrollment

7,808 patients

Sex

Female

Ages

60 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women who are 60 to 90 years of age may be eligible to participate
  • Bone mineral density (BMD) T-Score at hip or spine must be less than -2.5

Exclusion criteria

  • BMD T-Score at the hip or the spine of less than -4.0
  • Patients with any severe or more than two moderate vertebral fractures on spinal x-ray at entry

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

7,808 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo administered subcutaneously once every 6 months for 3 years.
Treatment:
Drug: placebo
Denosumab 60 mg Q6M
Experimental group
Description:
Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
Treatment:
Drug: Denosumab

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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