Selective Estrogen Receptor Modulator (SERM)NCT02977949
The Effects of Seasonal Changes in Osteoporosis Treatment
An observational study of Selective Estrogen Receptor Modulator (SERM), run by Toshihiko Kono at 1 site in Japan.
Trial summary
There are few reports concerning to the seasonal variation of osteoporosis treatment. In this study, we plan to compare clinical efficacy and safety by seasons. Read more about this study
- Who is it for?
- Ages 45 to 100 years, women only
- Conditions the study is for
- Selective Estrogen Receptor Modulator (SERM)
- What is being tested?
- Raloxifene
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2012to Dec 2019
- How long will I take part?
- 24 Months
- 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 45 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Osteoporosis patients using raloxifene more for two years.
Who may be able to join
- Postmenopausal women
Who cannot join
- Patients who could not use SERM
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Tomidahama Hospital
Yokkaichi, Mie-ken, 510-8008
Rui Niimi, MD, PhD, (81)-59-365-0023, furikakefuri@hotmail.co.jp
About this study
There are few reports concerning to the seasonal variation of osteoporosis treatment. In this study, we plan to compare clinical efficacy and safety by seasons.
Read the detailed description
Vitamin D insufficiency is common in many countries. Vitamin D insufficiency is associated with osteoporosis and the responses to osteoporosis treatment. 25-hydroxyvitamin D (25OHD) is considered to be the best estimate of body stores of vitamin D and the seasonal variation of 25OHD is well known. But there are few reports concerning to the seasonal variation of osteoporosis treatment. In this study, we plan to compare clinical efficacy and safety by seasons in patients treated by raloxifene.
- Being tested
- Raloxifene
- Keywords
- SERM, Season, Variation, Vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaloxifeneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of raloxifene on bone mineral density in postmenopausal osteoporosis.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startJan 2012
- Primary completionJul 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Selective Estrogen Receptor Modulator (SERM)Studies 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
- 200 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Toshihiko Kono
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Toshihiko Kono, Tomidahama Hospital
- Investigators
- Rui Niimi, MD, Study director, Tomidahama Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977949
- Sponsor's protocol ID
- TH 05-2
- Status last verified
- Nov 2016
- First submitted
- 23 Nov 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Seasonal Changes in Osteoporosis Treatment
- ClinicalTrials.gov ID
- NCT02977949
- Acronym / sponsor ID
- TH 05-2
- Keywords
- SERM, Season, Variation, Vitamin D
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Toshihiko KonoUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 30 Nov 2016 (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.
There are few reports concerning to the seasonal variation of osteoporosis treatment. In this study, we plan to compare clinical efficacy and safety by seasons.
Detailed description
Vitamin D insufficiency is common in many countries. Vitamin D insufficiency is associated with osteoporosis and the responses to osteoporosis treatment. 25-hydroxyvitamin D (25OHD) is considered to be the best estimate of body stores of vitamin D and the seasonal variation of 25OHD is well known. But there are few reports concerning to the seasonal variation of osteoporosis treatment. In this study, we plan to compare clinical efficacy and safety by seasons in patients treated by raloxifene.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 45 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Osteoporosis patients using raloxifene more for two years.
Key inclusion criteria (1 listed)
- Postmenopausal women
Key exclusion criteria (1 listed)
- Patients who could not use SERM
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 |
|---|---|---|
| Raloxifene | Drug | – |
Primary outcome
Effects of raloxifene on bone mineral density in postmenopausal osteoporosis.
Time frame: Up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 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.
Rui Niimi, MD study director
Tomidahama 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 Selective Estrogen Receptor Modulator (SERM), run by Toshihiko Kono 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: status not confirmed, as of the sponsor's last update on 30 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 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.
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 Rui Niimi, MD ((81)-59-365-0023, furikakefuri@hotmail.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of raloxifene on bone mineral density in postmenopausal osteoporosis. (time frame: Up to 36 months). 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 30 Nov 2016.