OsteoporosisPhase 4NCT01904110

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

A Phase 4 study testing Risedronate/Cholecalciferol combination(montly) and Risedronate/Cholecalciferol combination(weekly) in people with Osteoporosis, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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) Read more about this study

Who is it for?: Ages 19 years and older, women only
Conditions the study is for: Osteoporosis
What is being tested?: Risedronate/Cholecalciferol combination(montly) and Risedronate/Cholecalciferol combination(weekly)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 196 participants
Where: 1 siteSouth Korea
Study dates: Dec 2012to 31 Mar 2016
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 11Show fewer

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Samsung Medical Center
Seoul

Other trials in South Korea

About this study

Official 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)

Read the detailed description

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)

Conditions: Osteoporosis
Being tested: Risedronate/Cholecalciferol combination(montly), Risedronate/Cholecalciferol combination(weekly)
Keywords: Risedronate,cholecalciferol,BMD,montly,weekly,compliance
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Risedronate/Cholecalciferol combination(montly)Drug
Also called Risenex M
once a month
Risedronate/Cholecalciferol combination(weekly)Drug
Also called Risenex Plus
once a week

Study groups in NCT01904110
Study group	Role	What they receive
Risenex M	Experimental	Patients who were treated with Resenex M (Risendronate/Cholecalciferol combination in one tablet) once a month for 12months Receives: Drug: Risedronate/Cholecalciferol combination(montly)
Risenex Plus	Active comparator	Patients who were treated with Risenex plus (Risendronate/Cholecalciferol combination in one tablet) once a week for 12months Receives: Drug: Risedronate/Cholecalciferol combination(montly); Drug: Risedronate/Cholecalciferol combination(weekly)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

The change of Bone Mineral Density(BMD) value
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)
Measured: 1year
The change of PTH(Parathyroid hormone value)
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)
Measured: 6months,1 year
The change of Compliance - overall groups of Risenex plus vs Risenex M
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
Measured: 1year
The change of 25(Oh)D level in patients.
Measured: 6months,1year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201231 Mar 2016

First posted22 Jul 2013 (estimated)
Study startDec 2012
Primary completion29 May 2014
Study completion31 Mar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for OsteoporosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01904110
Sponsor's protocol ID: HL_RSNM_401
Status last verified: Aug 2018
First submitted: 16 Jul 2013
Last updated: 29 Aug 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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)
ClinicalTrials.gov ID: NCT01904110
Acronym / sponsor ID: HL_RSNM_401
Conditions: Osteoporosis
Keywords: Risedronate,cholecalciferol,BMD,montly,weekly,compliance
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: 29 May 2014 (actual)
Study completion: 31 Mar 2016 (actual)
First posted: 22 Jul 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Risenex M	Experimental	Drug: Risedronate/Cholecalciferol combination(montly)Patients who were treated with Resenex M (Risendronate/Cholecalciferol combination in one tablet) once a month for 12months
Risenex Plus	Active comparator	Drug: Risedronate/Cholecalciferol combination(montly), Drug: Risedronate/Cholecalciferol combination(weekly)Patients who were treated with Risenex plus (Risendronate/Cholecalciferol combination in one tablet) once a week for 12months

Who may qualify

Ages: 19 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Female osteoporosis patients over 19years of age(with menopause).
Definition of osteporosis
Definition of menopause(can be one of three condition)
Patients who can be treated with oral bisphosphonate drugs
Patients who have adequate to be measured DXA(Dual energy x-ray absorptiometry)

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Risedronate/Cholecalciferol combination(montly)Also: Risenex Monce a month	Drug	Risenex M, Risenex Plus
Risedronate/Cholecalciferol combination(weekly)Also: Risenex Plusonce a week	Drug	Risenex Plus

Primary outcome

The propotion of patients with 25(Oh)D level <20mg/ml of 12 months
Time frame: 1 year

4 secondary outcomes

The change of Bone Mineral Density(BMD) value
Time frame: 1year
The change of PTH(Parathyroid hormone value)
Time frame: 6months,1 year
The change of Compliance - overall groups of Risenex plus vs Risenex M
Time frame: 1year
The change of 25(Oh)D level in patients.
Time frame: 6months,1year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.

Related trials for Osteoporosis

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Youngki Min, MD principal investigator

Samsung Medical Center Seoul

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The propotion of patients with 25(Oh)D level <20mg/ml of 12 months (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01904110.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.