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Completed

NCT Number: NCT01904110

To Evaluate the Efficacy and the Safety of Monthly Versus Weekly Oral Risedronate With Vitamin D in Compliance, Improvement of Vitamin D and BMD in Korean Postmenopausal Osteoporotic Women

The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM group) versus Weekly Oral risedronate(Risenexsplus group) in Korean postmenopausal osteoporotic women(Phase IV)

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM group) versus Weekly Oral risedronate(Risenexsplus group) with Vitamin D in compliance, improvement of vitaminD and BMD in Korean postmenopausal osteoporotic women(Phase IV)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female osteoporosis patients over 19years of age(with menopause).

Definition of osteporosis

  • They had a BMD T-score -2.5 or less at mean Lumbar spine(L1~L4), Femoral neck or total. Or evidence of at least one vertebral fracture.

Definition of menopause(can be one of three condition)

  • For 12months spontaneous amenorrhea
  • For 6months spontaneous amenorrhea with serum FSH(Follicle stimulating hormone) is 40 mlIU/mL and over
  • 6weeks after bilateral ovariectomy whether hysterectomy of not
  • Patients who can be treated with oral bisphosphonate drugs
  • Patients who have adequate to be measured DXA(Dual energy x-ray absorptiometry)
  • Patients who made a voluntary agreement after explanation of this study
  • Patients who participated in clinical trial(HL_RSNP_401) must have taken the Risenexplus and finish the study for 12 months.

Exclusion criteria

  • Patients with esophagus disorder.
  • Patients administered with osteoprosis therapy(except calcium,Vit.D medication) within previous 3 months
  • Patients with serum calcium concentrations 8.0mg/dL under.
  • Patients with severe nephropathy(serum creatinine> doulble of normal level
  • Patients with unable to sit upright or stand 30minutes.

Treatment and study plan

Risedronate/Cholecalciferol combination(montly)

Drug

once a month

Other names: Risenex M

Risedronate/Cholecalciferol combination(weekly)

Drug

once a week

Other names: Risenex Plus

Primary outcomes

  1. The propotion of patients with 25(Oh)D level <20mg/ml of 12 months

    Time frame: 1 year

Secondary outcomes

  1. The change of Bone Mineral Density(BMD) value

    Time frame: 1year

    The change of Bone Mineral Density(BMD) value[Time frame: 1 year] The change of PTH(Parathyroid hormone value) [Time frame:6months,1 year] The change of Compliance - overall groups of Risenex plus vs Risenex M(2groups)

  2. The change of PTH(Parathyroid hormone value)

    Time frame: 6months,1 year

    The change of Bone Mineral Density(BMD) value[Time frame: 1 year] The change of PTH(Parathyroid hormone value) [Time frame:6months,1 year] The change of Compliance - overall groups of Risenex plus vs Risenex M(2groups)

  3. The change of Compliance - overall groups of Risenex plus vs Risenex M

    Time frame: 1year

    The change of Bone Mineral Density(BMD) value[Time frame: 1 year] The change of PTH(Parathyroid hormone value) [Time frame:6months,1 year] The change of Compliance - overall groups of Risenex plus vs Risenex M(2groups

  4. The change of 25(Oh)D level in patients.

    Time frame: 6months,1year

Sponsors and collaborators

Lead sponsor

Hanlim Pharm. Co., Ltd.

Industry

Registry information

Official study title

For 12months, the Multi Center, Randomized, Open-label Comparative Clinical Study to Evaluate the Efficacy and the Safety of Monthly(RisenexM Group) Versus Weekly Oral Risedronate(Risenexsplus Group) With Vitamin D in Compliance, Improvement of Vitamin D and BMD in Korean Postmenopausal Osteoporotic Women(Phase IV)

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Jul 22, 2013
Registry last updated
Aug 29, 2018

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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