Completed
For 4 Months, the Multi Center, Double Blinded, Randomized, Active Controlled, Comparative Clinical Study to Assess the Efficacy and the Safety to Improvement Effect of Vit.D of Risenex Plus M Tablet in Patients With In Post-menopausal Women Osteoporosis
What is being tested
risedronate combine
+ Placebo(for Risedronate)
+ Risedronate
Drug
Who is being recruted
Bone Diseases+3
+ Bone Diseases, Metabolic
+ Metabolic Diseases
+11 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: November 2009
Summary
Principal SponsorHanlim Pharm. Co., Ltd.
Last updated: March 7, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2009
Actual date on which the first participant was enrolled.The purpose of this study is to evaluate the efficacy and the safety of Monthly Risedronate with cholecalciferol on 25 Hydroxyvitamin D level and bone markers patients with osteoporosis.
Principal SponsorHanlim Pharm. Co., Ltd.
Last updated: March 7, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
150 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Bone DiseasesBone Diseases, MetabolicMetabolic DiseasesMusculoskeletal DiseasesNutritional and Metabolic DiseasesOsteoporosis
Criteria
5 inclusion criteria required to participate
low levels of 25(OH)D > 9 ng/mL
patients who can read and understand written instructions
patients who give written consent of agreement to voluntarily participate in the clinical study
patients with a diagnosis of Postmenopausal over 6 Months if they had a bone mineral density T-score of < -2.5 at the mean lumbar spine (L1-4), femoral neck, or total, or a T-score of < -1.0 with radiologic evidence of at least one vertebral fracture. Menopause was defined as no natural menses for at least 1 year and a serum FSH level > 40 IU/L, with a reported hysterectomy
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6 exclusion criteria prevent from participating
ALT, AST >= 2xUNL and Serum Creatinine >= 1.5xUNL
Previous use of oral bisphosphonates and vitamin D were allowed, but a washout period was needed, depending on the duration of treatment. Two-year washout periods were needed for bisphosphonate users and 3-6-month periods were required for vitamin D users of > 200 IU
drug administration after diagnosing as alcoholic or psychical disease
low levels of 25(OH)D (less than 9 ng/mL)
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Experimentalrisedronate 150mg and cholecalciferol 30,000 IU 1 tablet + Placebo(for risedronate 150mg) 1 tablet by once a month.
Group II
Active Comparatorrisedronate 150mg 1 tablet + Placebo(for risedronate 150mg and cholecalciferol 30,000 IU) 1 tablet by once a month.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center