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

Paget's Disease of Bone Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480662
• Other study ID #: 0217-206
• Secondary ID: MK0217-2062007_5
• Status: Completed
• Phase: Phase 3
• Start date: October 2001
• Est. completion date: October 2002

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2002
• Est. primary completion date: October 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• alendronate
Duration of Treatment : 6 Months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Hooper M, Faustino A, Reid IR, Hosking D, Gilchrist NL, Selby P, Wu M, Salzmann G, West J, Leung A. Randomized, active-controlled study of once-weekly alendronate 280 mg high dose oral buffered solution for treatment of Paget's disease. Osteoporos Int. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months
Secondary	MK0217 will be safely tolerated