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CompletedNCT00389740Updated Aug 14, 2024

A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)

A Phase 3 interventional study of MK0217, /Duration of Treatment : 12 Months and Comparator : raloxifene hydrochloride /Duration of Treatment : 12 Months in Osteoporosis, Postmenopausal, sponsored by Organon and Co. Completed. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-08-14.

Sponsored by Organon and Co · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 6 months after the study started (first participant enrolled Apr 2001, registered Oct 2006).
Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
40 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Osteoporosis, Postmenopausal
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 400 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
400 participants (actual)

Interventions

  • DrugMK0217, /Duration of Treatment : 12 Months
  • DrugComparator : raloxifene hydrochloride /Duration of Treatment : 12 Months
06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 15243278 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00389740
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Oct 19, 2006
Start date
Apr 2, 2001
Primary completion
Jan 16, 2003
Completion
Jan 16, 2003
Last update
Aug 14, 2024

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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