NCT00092027

Brief Summary

This study is to assess the safety and tolerability of MK0217 being evaluated to treat women with postmenopausal osteoporosis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
454

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2003

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

March 19, 2003

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2004

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2004

Completed
Last Updated

August 14, 2024

Status Verified

February 1, 2022

Enrollment Period

12 months

First QC Date

September 21, 2004

Last Update Submit

August 12, 2024

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • To evaluate the upper gastrointestinal (UGI) safety and tolerability of 6 months of treatment with once weekly alendronate 70 mg in an oral buffered solution in comparison to placebo in postmenopausal women with osteoporosis

Secondary Outcomes (2)

  • To evaluate the overall safety and tolerability of once weekly alendronate 70 mg oral buffered solution versus placebo

  • To evaluate the mean percent change from baseline in bone markers (BSAP, Urinary NTx) at 6 months

Interventions

MK0217, alendronate sodium/Duration of Treatment: 6 monthsDRUG
Comparator: placebo / Duration of Treatment: 6 monthsDRUG

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with postmenopausal osteoporosis

You may not qualify if:

  • High risk for fractures
  • Esophageal abnormalities
  • Upper gastrointestinal symptoms that are not relieved with medication
  • Metabolic bone disease (example - vitamin D deficiency)
  • Medications that would affect the breakdown or build-up of bone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cryer B, Binkley N, Simonelli C, Lewiecki EM, Lanza F, Chen E, Petruschke RA, Mullen C, de Papp AE. A randomized, placebo-controlled, 6-month study of once-weekly alendronate oral solution for postmenopausal osteoporosis. Am J Geriatr Pharmacother. 2005 Sep;3(3):127-36. doi: 10.1016/s1543-5946(05)80019-4.

    PMID: 16257815BACKGROUND

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

AlendronateDuration of Therapy

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

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

September 21, 2004

First Posted

September 24, 2004

Study Start

March 19, 2003

Primary Completion

March 15, 2004

Study Completion

March 15, 2004

Last Updated

August 14, 2024

Record last verified: 2022-02