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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092066

Enrollment

717

Registered

2004-09-24

Start date

2003-09-24

Completion date

2004-05-01

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, 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 the treatment of osteoporosis in men and postmenopausal women.

Interventions

DRUGMK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 15 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 significant medical conditions that are not adequately treated

Design outcomes

Primary

Measure	Time frame
Proportion of patients with Vitamin D insufficiency (defined as serum 25-hydroxyvitamin levels <15 ng/mL) after 15 weeks of treatment.	—

Secondary

Measure	Time frame
Proportion of patients with vitamin D deficiency (serum 25-hydroxyvitamin D levels <9 ng/mL) after 15 weeks of treatment.	—

Outcome results

None listed

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