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Completed

NCT Number: NCT01806792

Post-menopausal Women Osteoporosis(Phase III)

The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis

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Key information

Conditions

Postmenopausal Women Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Chung-ang university hospital

Seoul, 156-755, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

risedronate combine

Drug

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

risedronate

Drug

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

Placebo(for Risedronate)

Drug

Other names: once a month

Placebo(for risedronate combine)

Drug

Other names: once a month

Primary outcomes

  1. proportion of patients with 25(OH)D level < 20 ng/mL at 16 weeks.

    Time frame: 16 weeks form first drug adminstration.

Secondary outcomes

  1. proportion of patients with 25(OH)D level < 9 ng/mL at 16 weeks, change of 25(OH)D level and Bone Markers.

    Time frame: 16 weeks form first drug administration.

    Secondary end point is :

    • proportion of patients with 25(OH)D level < 9 ng/mL at 16 weeks
    • change of 25(OH)D level
    • change of BSAP
    • change of CTX
    • change of Ca
    • change of phosphorous
    • change of PTH
    • change of 8-foot walking test, Sit-To-Stand test

Sponsors and collaborators

Lead sponsor

Hanlim Pharm. Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Mar 7, 2013
Registry last updated
Mar 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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