Postmenopausal OsteoporosisNCT05433207
Post-Marketing Drug Intensive Monitoring Surveillance of EDIROL in Patients With Postmenopausal Osteoporosis
An observational study of Postmenopausal Osteoporosis, run by Chugai Pharmaceutical at 1 site in China.
Trial summary
This is a post-marketing drug intensive monitoring surveillance with an observational, non-interventional design. The objectives are to compare the incidence of hypercalcemia in patients with and without calcium intake (including dietary supplements, excepting calcium from meals), and to monitor the type, incidence… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Eldecalcitol soft capsules
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Jan 2025
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Postmenopausal osteoporosis patients who signed the informed consent form and are expected to receive Edirol during the intensive monitoring period.
Who may be able to join
- Postmenopausal osteoporosis patients who signed the informed consent form and are expected to receive Edirol during the intensive monitoring period.
- Patients with postmenopausal osteoporosis
- Patients who signed the informed consent form
- Patients who are expected to receive Edirol during planned enrollment period
Who cannot join
- Exclude if any of the following:
- Men
- No osteoporosis
- Other osteoporosis (not postmenopausal)
- Started Edirol before ICF signature
- Did not sign ICF
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, 100730
Weibo Xia, xiaweibo@medmail.com.cn
About this study
Official title: EDIROL Drug Intensive Monitoring: Post-Marketing Drug Intensive Monitoring Surveillance of EDIROL in Patients With Postmenopausal Osteoporosis
This is a post-marketing drug intensive monitoring surveillance with an observational, non-interventional design. The objectives are to compare the incidence of hypercalcemia in patients with and without calcium intake (including dietary supplements, excepting calcium from meals), and to monitor the type, incidence, severity, and relevance of other adverse drug reactions,including urolithiasis.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Eldecalcitol soft capsules
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eldecalcitol soft capsulesDrug
0.75 μg orally once a day during the intensive monitoring period. (The dose can be appropriately reduced to 0.5 μg according to symptoms, once a day.)
What is being measured
The primary outcome is the main question the study is designed to answer.
the rates of hypercalcemia and 95% confidence intervals for patients with and without calcium preparation intake
Measured: one year from Edirol dosing date
the odds ratios of hypercalcemia and 95% confidence intervals for patients with and without calcium preparation intake
Measured: one year from Edirol dosing date
the proportion of each type of adverse drug reactions (including hypercalcemia, urolithiasis, etc.)
Measured: through study completion, up to one year
the incidence of adverse drug reactions (including hypercalcemia, urolithiasis, etc.)
Measured: through study completion, up to one year
the severity of adverse drug reactions (including hypercalcemia, urolithiasis, etc.)
Measured: through study completion, up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Aug 2022 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weibo Xia, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433207
- Sponsor's protocol ID
- EDR2201CN
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EDIROL Drug Intensive Monitoring: Post-Marketing Drug Intensive Monitoring Surveillance of EDIROL in Patients With Postmenopausal Osteoporosis
- ClinicalTrials.gov ID
- NCT05433207
- Acronym / sponsor ID
- EDR2201CN
- Conditions
- Postmenopausal Osteoporosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 27 Jun 2022 (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.
This is a post-marketing drug intensive monitoring surveillance with an observational, non-interventional design. The objectives are to compare the incidence of hypercalcemia in patients with and without calcium intake (including dietary supplements, excepting calcium from meals), and to monitor the type, incidence, severity, and relevance of other adverse drug reactions,including urolithiasis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Postmenopausal osteoporosis patients who signed the informed consent form and are expected to receive Edirol during the intensive monitoring period.
Key inclusion criteria (4 listed)
- Postmenopausal osteoporosis patients who signed the informed consent form and are expected to receive Edirol during the intensive monitoring period.
Key exclusion criteria (6 listed)
- Exclude if any of the following:
- Started Edirol before ICF signature
- Did not sign ICF
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 |
|---|---|---|
| Eldecalcitol soft capsules0.75 μg orally once a day during the intensive monitoring period. (The dose can be appropriately reduced to 0.5 μg according to symptoms, once a day.) | Drug | – |
Primary outcome
the rates of hypercalcemia and 95% confidence intervals for patients with and without calcium preparation intake
Time frame: one year from Edirol dosing date
the odds ratios of hypercalcemia and 95% confidence intervals for patients with and without calcium preparation intake
Time frame: one year from Edirol dosing date
the proportion of each type of adverse drug reactions (including hypercalcemia, urolithiasis, etc.)
Time frame: through study completion, up to one year
the incidence of adverse drug reactions (including hypercalcemia, urolithiasis, etc.)
Time frame: through study completion, up to one year
the severity of adverse drug reactions (including hypercalcemia, urolithiasis, etc.)
Time frame: through study completion, up to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
Weibo Xia principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Osteoporosis, run by Chugai Pharmaceutical at 1 site in China.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Jun 2022. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ritsu Ki (only use E-mail, edrdimdisclosure@chugai-pharm.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rates of hypercalcemia and 95% confidence intervals for patients with and without calcium preparation intake (time frame: one year from Edirol dosing date). The study lists 5 primary outcomes in all. 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 27 Jun 2022.