OsteoporosisPhase 2NCT03755193
Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients
A Phase 2 study testing SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug", Bisphosphonates and ELD "Edirol®Tablet 0.75ug" and ELD "Edirol®Tablet 0.75ug" in people with Osteoporosis, run by Shinshu University at 1 site in Japan.
Trial summary
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in Japanese osteoporosis patients after 2-year-denosumab therapy: SERM and eldecalcitol treatment for 24 months Bisphosphonates and eldecalcitol treatment for 24 months Eldecalcitol treatment for 24 months Read more about this study
- Who is it for?
- Ages 20 to 120 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug", Bisphosphonates and ELD "Edirol®Tablet 0.75ug" and ELD "Edirol®Tablet 0.75ug"
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteJapan
- Study dates
- 24 Nov 2018to 23 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 20 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteoporosis patients
Who cannot join
- not osteoporosis patients who are allergic to the drugs, refused to do this research, or who are pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Yukio Nakamura
Matsumoto, Nagano, 3908621
Yukio Nakamura, MD, PhD, +81-263-37-2659, yxn14@aol.jp
Yukio Nakamura, MD, PhD
About this study
Official title: Examination of Efficacy and Safety of SERM or Bisphosphonates After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in Japanese osteoporosis patients after 2-year-denosumab therapy:
SERM and eldecalcitol treatment for 24 months Bisphosphonates and eldecalcitol treatment for 24 months Eldecalcitol treatment for 24 months
- Conditions
- Osteoporosis
- Being tested
- SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug", Bisphosphonates and ELD "Edirol®Tablet 0.75ug", ELD "Edirol®Tablet 0.75ug"
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"Drug
To examine the effects of SERM and ELD in osteoporosis patients
Bisphosphonates and ELD "Edirol®Tablet 0.75ug"Drug
To examine the effects of BP and ELD in osteoporosis patients
ELD "Edirol®Tablet 0.75ug"Drug
To examine the effects of ELD in osteoporosis patients
| Study group | Role | What they receive |
|---|---|---|
| SERM plus ELD | Active comparator | To examine the effects of SERM plus ELD in osteoporosis patients Receives: Drug: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"; Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug"; Drug: ELD "Edirol®Tablet 0.75ug" |
| BP plus ELD | Active comparator | To examine the effects of BP plus ELD in osteoporosis patients Receives: Drug: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"; Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug"; Drug: ELD "Edirol®Tablet 0.75ug" |
| ELD alone | Active comparator | To examine the effects of ELD alone in osteoporosis patients Receives: Drug: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"; Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug"; Drug: ELD "Edirol®Tablet 0.75ug" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD alone
Measured: Change from Baseline Values of bone mineral density at 2 years in each group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start24 Nov 2018
- Primary completion23 Nov 2024 (estimated)
- Study completion23 Nov 2026 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shinshu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yukio Nakamura, Shinshu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755193
- Sponsor's protocol ID
- DMAb switch 2018
- Status last verified
- Sep 2021
- First submitted
- 23 Nov 2018
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Efficacy and Safety of SERM or Bisphosphonates After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients
- ClinicalTrials.gov ID
- NCT03755193
- Acronym / sponsor ID
- DMAb switch 2018
- Conditions
- Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shinshu UniversityUniversity, hospital or other
- Study start
- 24 Nov 2018 (actual)
- Primary completion
- 23 Nov 2024 (estimated)
- Study completion
- 23 Nov 2026 (estimated)
- First posted
- 27 Nov 2018 (actual)
- 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.
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in Japanese osteoporosis patients after 2-year-denosumab therapy:
SERM and eldecalcitol treatment for 24 months Bisphosphonates and eldecalcitol treatment for 24 months Eldecalcitol treatment for 24 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SERM plus ELD | Active comparator | Drug: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug", Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug", Drug: ELD "Edirol®Tablet 0.75ug"To examine the effects of SERM plus ELD in osteoporosis patients |
| BP plus ELD | Active comparator | Drug: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug", Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug", Drug: ELD "Edirol®Tablet 0.75ug"To examine the effects of BP plus ELD in osteoporosis patients |
| ELD alone | Active comparator | Drug: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug", Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug", Drug: ELD "Edirol®Tablet 0.75ug"To examine the effects of ELD alone in osteoporosis patients |
Who may qualify
- Ages
- 20 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- osteoporosis patients
Key exclusion criteria (1 listed)
- not osteoporosis patients who are allergic to the drugs, refused to do this research, or who are pregnant
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 |
|---|---|---|
| SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"To examine the effects of SERM and ELD in osteoporosis patients | Drug | BP plus ELD, ELD alone, SERM plus ELD |
| Bisphosphonates and ELD "Edirol®Tablet 0.75ug"To examine the effects of BP and ELD in osteoporosis patients | Drug | BP plus ELD, ELD alone, SERM plus ELD |
| ELD "Edirol®Tablet 0.75ug"To examine the effects of ELD in osteoporosis patients | Drug | BP plus ELD, ELD alone, SERM plus ELD |
Primary outcome
Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD alone
Time frame: Change from Baseline Values of bone mineral density at 2 years in each group
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug", Bisphosphonates and ELD "Edirol®Tablet 0.75ug" and ELD "Edirol®Tablet 0.75ug" in people with Osteoporosis, run by Shinshu University at 1 site in Japan.
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: looking for participants now, as of the sponsor's last update on 21 Sep 2021. 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 Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yukio Nakamura (+81263372576, yxn14@aol.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD alone (time frame: Change from Baseline Values of bone mineral density at 2 years in each group). 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 21 Sep 2021.