OsteoporosisPhase 4NCT01675297

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

A Phase 4 study testing Risedronate/Cholecalciferol combination and Risedronate 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 Risedronate, cholecalciferol combination tablet in patients with Osteoporosis. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Osteoporosis
What is being tested?: Risedronate/Cholecalciferol combination and Risedronate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,053 participants
Where: 1 siteSouth Korea
Study dates: 4 Jul 2011to 15 Apr 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Chung-ang university hospital
Seoul, 156-755

Other trials in South Korea

About this study

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

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.

Conditions: Osteoporosis
Being tested: Risedronate/Cholecalciferol combination, Risedronate
Keywords: Risedronate, cholecalciferol, BMD
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 combinationDrug
Also called RisenexPlus tablet
Risendronate/Cholecalciferol combination once a week
RisedronateDrug
Also called Sedron 35mg tablet
Risedronate once a week

Study groups in NCT01675297
Study group	Role	What they receive
Risendronate/Cholecalciferol combination	Experimental	Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months Receives: Drug: Risedronate/Cholecalciferol combination
Risedronate	Active comparator	Sedron tablet: one tablet once a week for 12months Receives: Drug: Risedronate

What is being measured

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

The Change of Bone Mineral Density (BMD) Value
Higher Bone Mineral Density(BMD) value mean a better outcome.
Measured: baseline and 12 months

Secondary outcomes (2)

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.
Measured: baseline, 6months, 12months
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.
Measured: baseline, 6months, 12months

Timeline

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

4 Jul 201115 Apr 2014

First posted29 Aug 2012 (estimated)
Study start4 Jul 2011
Primary completionDec 2013
Study completion15 Apr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 1,053 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01675297
Sponsor's protocol ID: HL_RSNP_401
Status last verified: Mar 2019
First submitted: 27 Aug 2012
Last updated: 5 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
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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Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01675297
Acronym / sponsor ID: HL_RSNP_401
Conditions: Osteoporosis
Keywords: Risedronate, cholecalciferol, BMD
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,053 participants (actual)
Lead sponsor: Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
Study start: 4 Jul 2011 (actual)
Primary completion: Dec 2013 (actual)
Study completion: 15 Apr 2014 (actual)
First posted: 29 Aug 2012 (estimated)
Results: Posted 5 Aug 2019

Clinical summary

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

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.

Study design

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

Arm	Type	Receives
Risendronate/Cholecalciferol combination	Experimental	Drug: Risedronate/Cholecalciferol combinationRisendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months
Risedronate	Active comparator	Drug: RisedronateSedron tablet: one tablet once a week for 12months

Who may qualify

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

Key inclusion criteria (8 listed)

Male osteoporosis patients over 19 years of age
Female osteoporosis patients with menopause

Key exclusion criteria (5 listed)

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

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 combinationAlso: RisenexPlus tabletRisendronate/Cholecalciferol combination once a week	Drug	Risendronate/Cholecalciferol combination
RisedronateAlso: Sedron 35mg tabletRisedronate once a week	Drug	Risedronate

Primary outcome

The Change of Bone Mineral Density (BMD) Value
Time frame: baseline and 12 months
Higher Bone Mineral Density(BMD) value mean a better outcome.

2 secondary outcomes

The Change of 25OHD(25-hydroxyvitamin D)
Time frame: baseline, 6months, 12months
PTH(Parathyroid Hormone Value)
Time frame: baseline, 6months, 12months

Results and safety

Results posted to the registry on 5 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Risendronate/Cholecalciferol Combination	806	642
Risedronate	247	199

Primary outcome: The Change of Bone Mineral Density (BMD) Value

Time frame: baseline and 12 months. Mean (Standard Deviation). Unit: g/cm^2

Measure	Risendronate/Cholecalciferol Combination n = 642	Risedronate n = 199
baseline	0.77 (0.11)	0.77 (0.10)
12 months	0.81 (0.12)	0.80 (0.11)
change(12months-baseline)	0.04 (0.05)	0.03 (0.04)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12months. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Risendronate/Cholecalciferol Combination	61 of 806 (7.6%)	61 of 806 (7.6%)	9 of 806
Risedronate	19 of 247 (7.7%)	29 of 247 (11.7%)	1 of 247

Limitations and caveats (from the sponsor): Multiple centers proceded clinical study do not use the same measuring instrument.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Active, not recruitingObservational study
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Active, not recruitingPhase 2
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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.

Hyoung-Moo Park, MD principal investigator

Chung-Ang University Hospital

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

Questions about this trial

What is this clinical trial studying?

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

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 8 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 5 Aug 2019. 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?

Yes. Results are posted in the registry (first posted 5 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Change of Bone Mineral Density (BMD) Value (time frame: baseline and 12 months). 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 NCT01675297.

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 5 Aug 2019.