A Study of MK0217A and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)

A 15-Week, Double-Blind, Randomized, Active-Controlled, Multi-Center Study With 24-Week Extension to Evaluate the Safety, Tolerability, Efficacy of Alendronate 70 mg Plus Vitamin D3 2800 IU Combination Tablet in Men and Postmenopausal Women With Osteoporosis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092079

Enrollment

652

Registered

2004-09-24

Start date

2004-01-31

Completion date

2004-11-30

Last updated

2014-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Vitamin D Deficiency

Brief summary

The purpose of this study is to test the safety, tolerability, and effectiveness of an investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and deficiency during treatment of osteoporosis in men and postmenopausal women.

Interventions

DRUGMK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Men or postmenopausal women who are osteoporotic

Exclusion criteria

* Vitamin D deficiency * Other disease of bone or mineral metabolism * Digestive disease causing malabsorption * Other medical conditions that are not adequately treated

Design outcomes

Primary

Measure	Time frame
Safety and tolerability; primary parameter assessed is the proportion of patients who develop hypercalcuria	—

Outcome results

None listed

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