NCT00480662

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2001

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2007

Completed
Last Updated

August 14, 2024

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

May 30, 2007

Last Update Submit

August 12, 2024

Conditions

Paget's Disease of Bone

Keywords

Paget's bone disease

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • MK0217 will be safely tolerated

Interventions

alendronateDRUG

Duration of Treatment : 6 Months

Also known as: MK0217

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. 2009 Jan;20(1):141-50. doi: 10.1007/s00198-008-0639-6. Epub 2008 Jun 7.

    PMID: 18536953RESULT

MeSH Terms

Conditions

Osteitis Deformans

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2007

First Posted

May 31, 2007

Study Start

October 1, 2001

Primary Completion

October 1, 2002

Study Completion

October 1, 2002

Last Updated

August 14, 2024

Record last verified: 2022-02