Trial | NCT01806792  Report issue

Title

Post-menopausal Women Osteoporosis(Phase III)
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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    risedronate ...

  • Study Participants

    150
The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis
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.
Study Started
Nov 30
2009
Primary Completion
Aug 31
2010
Study Completion
Mar 31
2011
Last Update
Mar 07
2013
Estimate

Drug risedronate combine

  • Other names: - Other name : Risenex M(risedronate 150mg and cholecalciferol 30,000 IU combined)

Drug Risedronate

  • Other names: Other name : Actonel(Risedronate 150mg)

Drug Placebo(for Risedronate)

  • Other names: once a month

Drug Placebo(for risedronate combine)

  • Other names: once a month

Risendronate and Cholecalciferol combination Experimental

risedronate 150mg and cholecalciferol 30,000 IU 1 tablet + Placebo(for risedronate 150mg) 1 tablet by once a month.

Risedronate Active Comparator

risedronate 150mg 1 tablet + Placebo(for risedronate 150mg and cholecalciferol 30,000 IU) 1 tablet by once a month.

Criteria 

Inclusion Criteria:

women osteoporosis
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
low levels of 25(OH)D > 9 ng/mL
patients who give written consent of agreement to voluntarily participate in the clinical study
patients who can read and understand written instructions

Exclusion Criteria:

patients who had contraindications to oral bisphosphonates, such as esophageal strictures
ALT, AST ≥ 2×UNL and Serum Creatinine ≥ 1.5×UNL
low levels of 25(OH)D (less than 9 ng/mL).
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
patients whom the investigators judge as improper to participate in this clinical trial 7)13.patients who have experience to participate in other clinical trial within 30 days prior to study participation
No Results Posted