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Completed

NCT Number: NCT01675297

Efficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis

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

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

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 Risedronate with and without cholecalciferol on vitamin D status, Bone Mineral Density (BMD) and bone markers.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male osteoporosis patients over 19 years of age
  • Female osteoporosis patients with menopause
  • Definition of osteoporosis
  • 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 40mlU/mL and over
  • 6weeks after bilateral ovariectomy whether hysterectomy or not.

Exclusion criteria

  • Patients with esophagus disorder (i.e:esophagostenosis)
  • Patients administered with osteoporosis therapy(except calcium, Vit.D medication)within the previous 3 Months
  • Patients with serum calcium concentrations 8.0mg under
  • Patients with severe nephropathy (CCr 30mL/min less)
  • Patients with unable to sit upright or stand for 30minutes

Treatment and study plan

Risedronate/Cholecalciferol combination

Drug

Risendronate/Cholecalciferol combination once a week

Other names: RisenexPlus tablet

risedronate

Drug

Risedronate once a week

Other names: Sedron 35mg tablet

Primary outcomes

  1. The Change of Bone Mineral Density (BMD) Value

    Time frame: baseline and 12 months

    Higher Bone Mineral Density(BMD) value mean a better outcome.

Secondary outcomes

  1. The Change of 25OHD(25-hydroxyvitamin D)

    Time frame: baseline, 6months, 12months

    range of 25OHD: 4.80~52.80 Higher 25OHD scores mean a better outcome.

    If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.

  2. PTH(Parathyroid Hormone Value)

    Time frame: baseline, 6months, 12months

    range of PTH: 13~54 Higher PTH scores mean a worse outcome.

    If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.

Sponsors and collaborators

Lead sponsor

Hanlim Pharm. Co., Ltd.

Industry

Registry information

Official study title

For 12months, the Multi Center, Randomized, Open-label, Active Controlled Comparative Clinical Study to Assess the Efficacy and the Safety of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Aug 29, 2012
Registry last updated
Aug 5, 2019

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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