- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02977949
The Effects of Seasonal Changes in Osteoporosis Treatment
November 26, 2016 updated by: Toshihiko Kono
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rui Niimi, MD
- Phone Number: (81)-59-365-0023
- Email: furikakefuri@hotmail.co.jp
Study Locations
-
-
Mie
-
Yokkaichi, Mie, Japan, 510-8008
- Recruiting
- Tomidahama Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Osteoporosis patients using raloxifene more for two years.
Description
Inclusion Criteria:
- Postmenopausal women
Exclusion Criteria:
- Patients who could not use SERM
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effects of raloxifene on bone mineral density in postmenopausal osteoporosis.
Time Frame: Up to 36 months
|
Up to 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Anticipated)
July 1, 2018
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
November 23, 2016
First Submitted That Met QC Criteria
November 26, 2016
First Posted (Estimate)
November 30, 2016
Study Record Updates
Last Update Posted (Estimate)
November 30, 2016
Last Update Submitted That Met QC Criteria
November 26, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Osteoporosis
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Bone Density Conservation Agents
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Raloxifene Hydrochloride
Other Study ID Numbers
- TH 05-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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