NCT01406548

Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density

A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Assess the Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Ultragenyx Pharmaceutical Inc · Industry
• Sex: Female
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to provide information on the safety, tolerability, pharmacokinetics (PK) and bone biomarker response following multiple BPS804 administration in multiple dosing regimens. This information will permit a comparison of the possible risks and benefits of different dosing regimens of the study drug to enable optimal doses and dose intervals to be tested in subsequent studies.

Detailed description

This study was conducted and previously posted by Novartis. The record was transferred to Ultragenyx in February 2021.

Conditions

• Osteopenia
• Osteoporosis

Interventions

Type	Name	Description
DRUG	BPS804 20mg/Kg
DRUG	Placebo to 20mg/Kg BPS804

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2011-08-01
• Last updated: 2022-09-15

Locations

5 sites across 1 country: United States