NCT00389740

Brief Summary

The purpose of this study is to compare how well alendronate and raloxifene increase the bone density in women who have osteoporosis and have experienced menopause.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2001

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

April 2, 2001

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2003

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
Last Updated

August 14, 2024

Status Verified

February 1, 2022

Enrollment Period

1.8 years

First QC Date

October 18, 2006

Last Update Submit

August 12, 2024

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

  • Bone Mineral Density (BMD) in PA lumbar spine at 12 months

Secondary Outcomes (1)

  • Bone Mineral Density (BMD) in hip at 12 months; bone turnover at 6 and 12 months

Interventions

MK0217, /Duration of Treatment : 12 MonthsDRUG
Comparator : raloxifene hydrochloride /Duration of Treatment : 12 MonthsDRUG

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is postmenopausal (or surgically menopausal) for at least 6 months
  • Patient must be diagnosed with osteoporosis
  • Patient has spinal anatomy suitable for DEXA of the lumbar spine

You may not qualify if:

  • Patient is receiving or has received treatment prior to randomization which might influence bone turnover
  • Patient has a history of or evidence for metabolic bone disease (other than postmenopausal bone loss)
  • Patient is receiving or is expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Luckey M, Kagan R, Greenspan S, Bone H, Kiel RD, Simon J, Sackarowitz J, Palmisano J, Chen E, Petruschke RA, de Papp AE. Once-weekly alendronate 70 mg and raloxifene 60 mg daily in the treatment of postmenopausal osteoporosis. Menopause. 2004 Jul-Aug;11(4):405-15. doi: 10.1097/01.gme.0000119981.77837.1f.

    PMID: 15243278BACKGROUND

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Duration of Therapy

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Patient 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

October 18, 2006

First Posted

October 19, 2006

Study Start

April 2, 2001

Primary Completion

January 16, 2003

Study Completion

January 16, 2003

Last Updated

August 14, 2024

Record last verified: 2022-02