- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00092066
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)
February 1, 2022 updated by: Organon and Co
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
717
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Proportion of patients with Vitamin D insufficiency (defined as serum 25-hydroxyvitamin levels <15 ng/mL) after 15 weeks of treatment.
|
Secondary Outcome Measures
Outcome Measure |
---|
Proportion of patients with vitamin D deficiency (serum 25-hydroxyvitamin D levels <9 ng/mL) after 15 weeks of treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 24, 2003
Primary Completion (Actual)
May 1, 2004
Study Completion (Actual)
May 1, 2004
Study Registration Dates
First Submitted
September 21, 2004
First Submitted That Met QC Criteria
September 23, 2004
First Posted (Estimate)
September 24, 2004
Study Record Updates
Last Update Posted (Actual)
February 2, 2022
Last Update Submitted That Met QC Criteria
February 1, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Nutrition Disorders
- Musculoskeletal Diseases
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Bone Diseases
- Bone Diseases, Metabolic
- Vitamin D Deficiency
- Osteoporosis
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
- Alendronate
Other Study ID Numbers
- 0217A-227
- 2004_020
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vitamin D Deficiency
-
Federal University of Rio Grande do SulCompletedDeficiency, Vitamin DBrazil
-
University Hospital, Clermont-FerrandTerminated
-
Rajavithi HospitalQueen Sirikit National Institute of Child HealthCompleted
-
Universidade de Passo FundoUnknownDeficiency, Vitamin DBrazil
-
Nutrition Institute, SloveniaEuropean Regional Development Fund; Vizera d.o.o.; Frutarom Etol d.o.o.CompletedVitamin B 12 Deficiency | Vitamin d Deficiency | Protein DeficiencySlovenia
-
Wageningen UniversityDSM Nutritional Products, Inc.; Top Institute Food and NutritionCompletedElderly, Frail | Deficiency, Vitamin DNetherlands
-
University of PaviaIstituti Clinici Scientifici Maugeri SpAUnknownVitamin D Deficiency | Vitamin D3 Deficiency | Vitamin DItaly
-
Okan UniversityArçelik A.Ş.Completed
-
Brigham and Women's HospitalCompletedVitamin d Deficiency
-
Bispebjerg HospitalCompletedObesity | Deficiency, Vitamin D
Clinical Trials on MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 15 weeks
-
Merck Sharp & Dohme LLCCompletedVitamin D Deficiency | Osteoporosis
-
Organon and CoCompletedOsteoporosis, Postmenopausal
-
Organon and CoCompletedPostmenopausal Osteoporosis
-
Merck Sharp & Dohme LLCCompleted
-
H. Lundbeck A/STerminated
-
Merck Sharp & Dohme LLCCompletedComplicated Intra-Abdominal Infections
-
Organon and CoCompleted
-
Organon and CoCompleted