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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00480662
Enrollment
60
Registered
2007-05-31
Start date
2001-10-31
Completion date
2002-10-31
Last updated
2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paget's Disease of Bone

Keywords

Paget's bone disease

Brief summary

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

Interventions

DRUGalendronate

Duration of Treatment : 6 Months

Sponsors

Organon and Co
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
MK0217 will be safely tolerated

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026