A Research Study to Test the Effectiveness of MK0217 in Patients With Paget's Bone Disease (0217-206)(COMPLETED)

To test the safety, effectiveness of MK0217 when taken once a week for six months in treating patients with Paget's bone disease.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Paget's Disease of Bone Bone Diseases Musculoskeletal Diseases Osteitis Deformans

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Male or female, ages 18 to 90 years with a diagnosis of Paget's bone disease

Exclusion criteria

Patient cannot stand or sit upright for at least 30 minutes
Patient has difficulty swallowing or problems with digestive system

Treatment and study plan

Alendronate

Drug

Duration of Treatment : 6 Months

Other names: MK0217

Primary outcomes

Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months

Secondary outcomes

MK0217 will be safely tolerated

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A 6-Month, Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Alendronate 280-mg Oral Buffered Solution Once Weekly in Patients With Paget's Disease of Bone

Important dates

Study start: 2001
Primary completion: 2002
Study completion: 2002
First posted: May 31, 2007
Registry last updated: Aug 14, 2024

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