FindTrial
Sign In

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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01675297
Enrollment
1053
Registered
2012-08-29
Start date
2011-07-04
Completion date
2014-04-15
Last updated
2019-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

Risedronate, cholecalciferol, BMD

Brief summary

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

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.

Interventions

DRUGRisedronate/Cholecalciferol combination

Risendronate/Cholecalciferol combination once a week

DRUGRisedronate

Risedronate once a week

Sponsors

Hanlim Pharm. Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Change of Bone Mineral Density (BMD) Valuebaseline and 12 monthsHigher Bone Mineral Density(BMD) value mean a better outcome.

Secondary

MeasureTime frameDescription
The Change of 25OHD(25-hydroxyvitamin D)baseline, 6months, 12monthsrange 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.
PTH(Parathyroid Hormone Value)baseline, 6months, 12monthsrange 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.

Countries

South Korea

Participant flow

Recruitment details

medical clinic

Pre-assignment details

wash out 7\ 14days

Participants by arm

ArmCount
Risendronate/Cholecalciferol Combination
Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months Risedronate/Cholecalciferol combination: Risendronate/Cholecalciferol combination once a week
806
Risedronate
Sedron tablet: one tablet once a week for 12months Risedronate: Risedronate once a week
247
Total1,053

Baseline characteristics

CharacteristicRisedronateTotalRisendronate/Cholecalciferol Combination
Age, Continuous65.51 years
STANDARD_DEVIATION 8.59
65.71 years
STANDARD_DEVIATION 8.04
65.77 years
STANDARD_DEVIATION 7.87
Body Mass Index (BMI)23.00 kg/m^2
STANDARD_DEVIATION 3
23.31 kg/m^2
STANDARD_DEVIATION 3.25
23.40 kg/m^2
STANDARD_DEVIATION 3.32
Osteoporosis disease period27.07 years
STANDARD_DEVIATION 40.44
24.65 years
STANDARD_DEVIATION 38.21
23.90 years
STANDARD_DEVIATION 37.49
Sex: Female, Male
Female
236 Participants990 Participants754 Participants
Sex: Female, Male
Male
11 Participants63 Participants52 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
9 / 8061 / 247
other
Total, other adverse events
61 / 80629 / 247
serious
Total, serious adverse events
61 / 80619 / 247

Outcome results

Primary

The Change of Bone Mineral Density (BMD) Value

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

Time frame: baseline and 12 months

ArmMeasureGroupValue (MEAN)Dispersion
Risendronate/Cholecalciferol CombinationThe Change of Bone Mineral Density (BMD) Valuebaseline0.77 g/cm^2Standard Deviation 0.11
Risendronate/Cholecalciferol CombinationThe Change of Bone Mineral Density (BMD) Value12 months0.81 g/cm^2Standard Deviation 0.12
Risendronate/Cholecalciferol CombinationThe Change of Bone Mineral Density (BMD) Valuechange(12months-baseline)0.04 g/cm^2Standard Deviation 0.05
RisedronateThe Change of Bone Mineral Density (BMD) Valuebaseline0.77 g/cm^2Standard Deviation 0.1
RisedronateThe Change of Bone Mineral Density (BMD) Value12 months0.80 g/cm^2Standard Deviation 0.11
RisedronateThe Change of Bone Mineral Density (BMD) Valuechange(12months-baseline)0.03 g/cm^2Standard Deviation 0.04
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Risendronate/Cholecalciferol CombinationPTH(Parathyroid Hormone Value)PTH(6months)37.34 pg/mlStandard Deviation 23.82
Risendronate/Cholecalciferol CombinationPTH(Parathyroid Hormone Value)PTH change(6months-baseline)-2.78 pg/mlStandard Deviation 23.36
Risendronate/Cholecalciferol CombinationPTH(Parathyroid Hormone Value)PTH(12months)39.17 pg/mlStandard Deviation 19.37
Risendronate/Cholecalciferol CombinationPTH(Parathyroid Hormone Value)PTH change(12months-baseline)-1.34 pg/mlStandard Deviation 27.31
Risendronate/Cholecalciferol CombinationPTH(Parathyroid Hormone Value)PTH(baseline)40.48 pg/mlStandard Deviation 30.95
RisedronatePTH(Parathyroid Hormone Value)PTH change(12months-baseline)6.16 pg/mlStandard Deviation 33.33
RisedronatePTH(Parathyroid Hormone Value)PTH(baseline)39.17 pg/mlStandard Deviation 34.04
RisedronatePTH(Parathyroid Hormone Value)PTH(6months)42.40 pg/mlStandard Deviation 27.79
RisedronatePTH(Parathyroid Hormone Value)PTH(12months)45.27 pg/mlStandard Deviation 23.68
RisedronatePTH(Parathyroid Hormone Value)PTH change(6months-baseline)3.39 pg/mlStandard Deviation 35.57
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Risendronate/Cholecalciferol CombinationThe Change of 25OHD(25-hydroxyvitamin D)25OHD(6months)28.93 ng/mlStandard Deviation 11.16
Risendronate/Cholecalciferol CombinationThe Change of 25OHD(25-hydroxyvitamin D)25OHD change(6months-baseline)10.74 ng/mlStandard Deviation 11.53
Risendronate/Cholecalciferol CombinationThe Change of 25OHD(25-hydroxyvitamin D)25OHD(12months)30.57 ng/mlStandard Deviation 11.89
Risendronate/Cholecalciferol CombinationThe Change of 25OHD(25-hydroxyvitamin D)25OHD change(12months-baseline)12.33 ng/mlStandard Deviation 13.33
Risendronate/Cholecalciferol CombinationThe Change of 25OHD(25-hydroxyvitamin D)25OHD(baseline)18.23 ng/mlStandard Deviation 11.59
RisedronateThe Change of 25OHD(25-hydroxyvitamin D)25OHD change(12months-baseline)0.53 ng/mlStandard Deviation 12.74
RisedronateThe Change of 25OHD(25-hydroxyvitamin D)25OHD(baseline)17.83 ng/mlStandard Deviation 10.99
RisedronateThe Change of 25OHD(25-hydroxyvitamin D)25OHD(6months)19.47 ng/mlStandard Deviation 12.53
RisedronateThe Change of 25OHD(25-hydroxyvitamin D)25OHD(12months)18.35 ng/mlStandard Deviation 11.73
RisedronateThe Change of 25OHD(25-hydroxyvitamin D)25OHD change(6months-baseline)1.68 ng/mlStandard Deviation 9.47

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026