A Study and 12 Month Extension to Evaluate Two Investigational Drugs in Postmenopausal Women With Osteoporosis (MK-0217-907)

A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Alendronate and Risedronate on Bone Mineral Density in Postmenopausal Women With Osteoporosis; A 12 Month Extension to: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Alendronate and Risedronate on Bone Mineral Density in Postmenopausal Women With Osteoporosis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092040

Enrollment

936

Registered

2004-09-24

Start date

2003-03-18

Completion date

2005-09-28

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

Osteoporosis, Postmenopausal

Brief summary

The purpose of this study and 12 month extension is to evaluate the effects of two investigational drugs on osteoporosis in postmenopausal women.

Interventions

DRUGMK0217, alendronate sodium/Duration of Intervention: 12 mo

DRUGComparator: risedronate / Duration of Intervention: 12 mo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Postmenopausal women with osteoporosis

Exclusion criteria

* Any known allergy to the study drug

Design outcomes

Primary

Measure	Time frame
Mean percent change from baseline in hip trochanter bone mineral density (BMD)	—

Secondary

Measure	Time frame
Mean percent change from baseline in PA lumbar spine, total hip, and femoral neck BMD	—

Outcome results

None listed

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