A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density

Amgen

Status and phase: Completed; Phase 2

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Placebo; Drug: Denosumab; Drug: Alendronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00293813

20050179

Details and patient eligibility

About

This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.

Enrollment: 247 patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Postmenopausal, ambulatory women between 50 and 70 years old who are generally in good health.
• Must have low bone mineral density and meet specific eligibility criteria.

Key Exclusion Criteria:

-Subjects must not currently be receiving any medication that affects bone metabolism or have an underlying condition that affects their ability to take alendronate or receive denosumab.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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247 participants in 3 patient groups, including a placebo group

3

Placebo Comparator group

Description:

Placebo for denosumab and placebo for alendronate

Treatment:

Drug: Placebo

1

Experimental group

Description:

denosumab and placebo for alendronate

Treatment:

Drug: Denosumab

2

Active Comparator group

Description:

Placebo for denosumab and alendronate

Treatment:

Drug: Alendronate