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A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug 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

NCT00092066•Organon and Co

View on ClinicalTrials.gov

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 the treatment of osteoporosis in men and postmenopausal women.

Eligibility

Age

40 - 90 years

Sex

ALL

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 significant medical conditions that are not adequately treated

Key Dates

Start Date

September 24, 2003

Primary Completion Date

May 1, 2004

Completion Date

May 1, 2004

Last Updated

August 14, 2024

Enrollment

717

ACTUAL participants

Conditions

OsteoporosisVitamin D Deficiency

Interventions

MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 15 weeks

DRUG

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

NCT06731608

OsteoporosisLower Limb Fracture

View study

RECRUITINGPHASE4

Step-down Therapy After Long-term Osteoporosis Treatment

NCT07281586

Osteoporosis

View study

RECRUITING

Smart Wearable Device (gaitQ): Walk Better Project

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)

Inclusion Criteria

Exclusion Criteria

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

Step-down Therapy After Long-term Osteoporosis Treatment

Smart Wearable Device (gaitQ): Walk Better Project

Automated Bone Age Estimation From Noncontrast Abdominal CT Using Deep Learning

Effect of Mechanical Loading and Bone Loss on Motor Neuron Activity-H-Reflex Relationship

The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients