A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Compare the Safety and Tolerability of an Oral Buffered Solution of Alendronate Sodium 70 mg Once-Weekly Versus Placebo for the Treatment of Osteoporosis in Postmenopausal Women

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092027

Enrollment

454

Registered

2004-09-24

Start date

2003-03-19

Completion date

2004-03-15

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

Postmenopausal Osteoporosis

Brief summary

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

Interventions

DRUGMK0217, alendronate sodium/Duration of Treatment: 6 months

DRUGComparator: placebo / Duration of Treatment: 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

25 Years to No maximum

Healthy volunteers

Inclusion criteria

* Women with postmenopausal osteoporosis

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Outcome results

None listed

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