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Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263) | Clinical Trials | Clareo Health

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Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)

A Prospective, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Fosamax Plus D in Postmenopausal Osteoporotic Women

NCT00729651•Organon and Co

View on ClinicalTrials.gov

Summary

To demonstrate the efficacy/safety of Fosamax Plus D

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study
•Patient has been diagnosed with osteoporosis
•Patient has been postmenopausal for more than 6 months
•Patient has no contraindication to taking oral bisphosphonates
•Patient is eligible for dual energy x-ray absorptiometry in spine or hip

Exclusion Criteria

•Patients with esophageal dysfunction
•Patients who can not sit or stand at least 30 minutes
•Patients who had a malignant disease or active systemic disease 5 years prior to participating in this trial
•Patients with diseases of bone or mineral metabolism besides osteoporosis or receiving therapies which affect bone metabolism or calcium metabolism
•Patients with history of major gastrointestinal disease (peptic ulcer, malabsorption, esophageal disease, gastritis, gastroduodenitis, etc.) within the last 6 months

Key Dates

Start Date

March 20, 2008

Primary Completion Date

April 10, 2009

Completion Date

April 10, 2009

Last Updated

April 23, 2024

Enrollment

343

ACTUAL participants

Conditions

Osteoporosis Postmenopausal

Interventions

alendronate sodium (+) cholecalciferol

DRUG

Comparator: Alendronate sodium (Fosamax)

DRUG

Comparator: Calcium

DIETARY_SUPPLEMENT

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

NCT07253493

Osteoporosis Postmenopausal

View study

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: April 23, 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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