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

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ClinicalTrials.gov Identifier: NCT01675297
Recruitment Status : Completed
First Posted : August 29, 2012
Results First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Risedronate/Cholecalciferol combination Drug: Risedronate Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1053 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 4, 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : April 15, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Experimental: Risendronate/Cholecalciferol combination
Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months
Drug: Risedronate/Cholecalciferol combination
Risendronate/Cholecalciferol combination once a week
Other Name: RisenexPlus tablet

Active Comparator: Risedronate
Sedron tablet: one tablet once a week for 12months
Drug: Risedronate
Risedronate once a week
Other Name: Sedron 35mg tablet




Primary Outcome Measures :
  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 Outcome Measures :
  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.




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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male osteoporosis patients over 19 years of age
  2. 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675297


Locations
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Korea, Republic of
Chung-ang university hospital
Seoul, Korea, Republic of, 156-755
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
Investigators
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Principal Investigator: Hyoung-Moo Park, MD Chung-Ang University Hosptial, Chung-Ang University College of Medicine

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Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT01675297     History of Changes
Other Study ID Numbers: HL_RSNP_401
First Posted: August 29, 2012    Key Record Dates
Results First Posted: August 5, 2019
Last Update Posted: August 5, 2019
Last Verified: March 2019
Keywords provided by Hanlim Pharm. Co., Ltd.:
Risedronate, cholecalciferol, BMD
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Cholecalciferol
Risedronic Acid
Etidronic Acid
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action