Postmenopausal Women With OsteoporosisPhase 3DIOSNCT01581320
Phase III Clinical Trial of DP-R206 and Bonvia In Postmenopausal Women With Osteoporosis
A Phase 3 study testing Test group and Reference group in people with Postmenopausal Women With Osteoporosis, run by Alvogen Korea at 1 site in South Korea.
Trial summary
A multicenter, randomized, double-blind, active-controlled, phase III clinical trial to evaluate the efficacy and safety of Dp-R206 and Bonviva for 16 weeks once a month on the improvement of vitamin D in postmenopausal women with osteoporosis. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Postmenopausal Women With Osteoporosis
- What is being tested?
- Test group and Reference group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Sep 2012
- Phase
- Phase 3
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female more than 40 years old in postmenopausal
Who cannot join
- Subject who has a history of malignant cancer
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 137-701
About this study
Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R206 and Bonviva for the Improvement of Vitamin D in Postmenopausal Women With Osteoporosis
A multicenter, randomized, double-blind, active-controlled, phase III clinical trial to evaluate the efficacy and safety of Dp-R206 and Bonviva for 16 weeks once a month on the improvement of vitamin D in postmenopausal women with osteoporosis.
- Conditions
- Postmenopausal Women With Osteoporosis
- Being tested
- Test group, Reference group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test groupDrug
Also called DP-R206 (Test drug), <Ibandronate 150mg + cholecalciferol(Vitamin D3) 24,000IU>
Once a month, administration of DP-R206 \& placebo for 16 weeks
Reference groupDrug
Also called Bonviva®, (Ibandronate 150mg)
Once a month, administration of Bonviva \& placebo for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| DP-R206 | Experimental | Not described Receives: Drug: Test group |
| Bonviva | Active comparator | Not described Receives: Drug: Reference group |
What is being measured
The primary outcome is the main question the study is designed to answer.
A ratio of subject whose 25 OHD concentration is less than 15ng/mL
A ratio of subject whose 25 OHD concentration is less than 15ng/mL after 16weeks
Measured: 16weeks
Secondary outcomes (2)
A ratio of subject whose 25 OHD concentration is less than 9ng/mL
A ratio of subject whose 25 OHD concentration is less than 9ng/mL after 16weeks
Measured: 16 weeks
Safety evaluation (AE, Lab test, Vital sign etc)
Measured: 16weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal Women With 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvogen Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moo-il Kang, MD, PhD, Study chair, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581320
- Sponsor's protocol ID
- DP-CTR206-03
- Acronym
- DIOS
- Status last verified
- Apr 2012
- First submitted
- 26 Feb 2012
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R206 and Bonviva for the Improvement of Vitamin D in Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT01581320
- Acronym / sponsor ID
- DIOS / DP-CTR206-03
- Conditions
- Postmenopausal Women With Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Alvogen KoreaIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Apr 2012 (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.
A multicenter, randomized, double-blind, active-controlled, phase III clinical trial to evaluate the efficacy and safety of Dp-R206 and Bonviva for 16 weeks once a month on the improvement of vitamin D in postmenopausal women with osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DP-R206 | Experimental | Drug: Test group |
| Bonviva | Active comparator | Drug: Reference group |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female more than 40 years old in postmenopausal
Key exclusion criteria (1 listed)
- Subject who has a history of malignant cancer
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 |
|---|---|---|
| Test groupAlso: DP-R206 (Test drug), <Ibandronate 150mg + cholecalciferol(Vitamin D3) 24,000IU>Once a month, administration of DP-R206 \& placebo for 16 weeks | Drug | DP-R206 |
| Reference groupAlso: Bonviva®, (Ibandronate 150mg)Once a month, administration of Bonviva \& placebo for 16 weeks | Drug | Bonviva |
Primary outcome
A ratio of subject whose 25 OHD concentration is less than 15ng/mL
Time frame: 16weeks
A ratio of subject whose 25 OHD concentration is less than 15ng/mL after 16weeks
2 secondary outcomes
A ratio of subject whose 25 OHD concentration is less than 9ng/mL
Time frame: 16 weeks
Safety evaluation (AE, Lab test, Vital sign etc)
Time frame: 16weeks
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 1 Nov 2016.
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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.
Moo-il Kang, MD, PhD study chair
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Test group and Reference group in people with Postmenopausal Women With Osteoporosis, run by Alvogen Korea 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 1 inclusion and 1 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 1 Nov 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
A ratio of subject whose 25 OHD concentration is less than 15ng/mL (time frame: 16weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2016.