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CompletedNCT01675297Updated Aug 5, 2019Results posted

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

A Phase 4 interventional study of Risedronate/Cholecalciferol combination and Risedronate in Osteoporosis, sponsored by Hanlim Pharm. Co., Ltd.. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-08-05.

Sponsored by Hanlim Pharm. Co., Ltd. · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jul 2011, registered Aug 2012).
Phase
Phase 4
Study type
Interventional
Enrollment
1,053
Allocation
Randomized
Ages
19 Years and older
Sex
All
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Study summary

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

Read the 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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Conditions studied

  • Osteoporosis

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Keywords

  • Risedronate, cholecalciferol, BMD
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In context

Osteoporosis

1,675 studies on the registry are indexed under Osteoporosis; 211 are open to participants now.

This study's enrollment of 1,053 is above the median of 95 across 1,152 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Hanlim Pharm. Co., Ltd. is the lead sponsor of 50 studies on the registry; 8 are open to participants now.

Browse Hanlim Pharm. Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,053 participants (actual)

Study arms

  • Experimental
    Risendronate/Cholecalciferol combination

    Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months

    Drug: Risedronate/Cholecalciferol combination

  • Active comparator
    Risedronate

    Sedron tablet: one tablet once a week for 12months

    Drug: Risedronate

Interventions

  • DrugRisedronate/Cholecalciferol combination

    Risendronate/Cholecalciferol combination once a week

    Also known as: RisenexPlus tablet

  • DrugRisedronate

    Risedronate once a week

    Also known as: Sedron 35mg tablet

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What researchers measure

Primary outcomes

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

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

    Time frame: baseline and 12 months

Secondary outcomes

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

    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.

    Time frame: baseline, 6months, 12months

  2. PTH(Parathyroid Hormone Value)

    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.

    Time frame: baseline, 6months, 12months

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Results

Posted Aug 5, 2019
Limitations and caveats
Multiple centers proceded clinical study do not use the same measuring instrument.

Participant flow

medical clinic

Participant flow — Overall Study
MilestoneRisendronate/Cholecalciferol CombinationRisedronate
Started806247
Completed642199
Not completed16448

Outcome measures

PrimaryThe Change of Bone Mineral Density (BMD) Value

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

Time frame:
baseline and 12 months
Reported as:
Mean · g/cm^2
The Change of Bone Mineral Density (BMD) Value
g/cm^2Risendronate/Cholecalciferol CombinationRisedronate
baseline0.77 ± 0.110.77 ± 0.10
12 months0.81 ± 0.120.80 ± 0.11
change(12months-baseline)0.04 ± 0.050.03 ± 0.04
SecondaryThe Change of 25OHD(25-hydroxyvitamin D)

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.

Time frame:
baseline, 6months, 12months
Reported as:
Mean · ng/ml
The Change of 25OHD(25-hydroxyvitamin D)
ng/mlRisendronate/Cholecalciferol CombinationRisedronate
25OHD(baseline)18.23 ± 11.5917.83 ± 10.99
25OHD(6months)28.93 ± 11.1619.47 ± 12.53
25OHD(12months)30.57 ± 11.8918.35 ± 11.73
25OHD change(6months-baseline)10.74 ± 11.531.68 ± 9.47
25OHD change(12months-baseline)12.33 ± 13.330.53 ± 12.74
SecondaryPTH(Parathyroid Hormone Value)

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.

Time frame:
baseline, 6months, 12months
Reported as:
Mean · pg/ml
PTH(Parathyroid Hormone Value)
pg/mlRisendronate/Cholecalciferol CombinationRisedronate
PTH(baseline)40.48 ± 30.9539.17 ± 34.04
PTH(6months)37.34 ± 23.8242.40 ± 27.79
PTH(12months)39.17 ± 19.3745.27 ± 23.68
PTH change(6months-baseline)-2.78 ± 23.363.39 ± 35.57
PTH change(12months-baseline)-1.34 ± 27.316.16 ± 33.33

Adverse events

Collected over 12months. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Risendronate/Cholecalciferol Combination9/806 (1.1%)61/806 (7.6%)61/806 (7.6%)
Risedronate1/247 (0.4%)19/247 (7.7%)29/247 (11.7%)
Most frequent serious events
Showing 10 of 62
Most frequent serious events
EventRisendronate/Cholecalciferol CombinationRisedronate
Femur fractureInjury, poisoning and procedural complications2/8062/247
Lumbar vertebral fractureInjury, poisoning and procedural complications2/8062/247
Radius fractureInjury, poisoning and procedural complications1/8061/247
Ankle fractureInjury, poisoning and procedural complications0/8061/247
Humerus fractureInjury, poisoning and procedural complications0/8061/247
Joint dislocationInjury, poisoning and procedural complications0/8061/247
Foot deformityMusculoskeletal and connective tissue disorders1/8061/247
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders1/8061/247
OsteoarthritisMusculoskeletal and connective tissue disorders1/8061/247
Back painMusculoskeletal and connective tissue disorders0/8061/247
Most frequent other events
Most frequent other events
EventRisendronate/Cholecalciferol CombinationRisedronate
DyspepsiaGastrointestinal disorders20/80611/247
NasopharyngitisInfections and infestations19/8068/247
MyalgiaMusculoskeletal and connective tissue disorders12/8065/247
Back painMusculoskeletal and connective tissue disorders10/8065/247

Baseline characteristics

Age, Continuous
Age, Continuous(years)Risendronate/Cholecalciferol CombinationRisedronateTotal
Mean65.77 ± 7.8765.51 ± 8.5965.71 ± 8.04
Sex: Female, Male
Sex: Female, Male(Participants)Risendronate/Cholecalciferol CombinationRisedronateTotal
Female754236990
Male521163
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)Risendronate/Cholecalciferol CombinationRisedronateTotal
Mean23.40 ± 3.3223.00 ± 3.0023.31 ± 3.25
Osteoporosis disease period
Osteoporosis disease period(years)Risendronate/Cholecalciferol CombinationRisedronateTotal
Mean23.90 ± 37.4927.07 ± 40.4424.65 ± 38.21
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Study locations

1 site
  • Chung-ang university hospital
    Seoul, 156-755, South Korea
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01675297
Lead sponsor
Hanlim Pharm. Co., Ltd.
Responsible party
Sponsor
First posted
Aug 29, 2012
Start date
Jul 4, 2011
Primary completion
Dec 2013
Completion
Apr 15, 2014
Results posted
Aug 5, 2019
Last update
Aug 5, 2019

Study contacts

Hyoung-Moo Park, MD
principal investigator · Chung-Ang University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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