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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alendronate

Drug

Alendronate 70 mg PO QW

Denosumab

Drug

denosumab 60 mg SC q 6 mos

Placebo

Drug

Placebo for alendronate and placebo for denosumab

Primary outcomes

Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12

Time frame: 12 months

Cortical Thickness measured by XtremeCT.

Secondary outcomes

Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12

Time frame: 12 months

Cortical Thickness measured by XtremeCT.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Feb 20, 2006
Registry last updated: Jul 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed