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The Effects of Seasonal Changes in Osteoporosis Treatment

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ClinicalTrials.gov Identifier: NCT02977949
Recruitment Status : Recruiting
First Posted : November 30, 2016
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):
Toshihiko Kono, Tomidahama Hospital

Brief 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.

Condition or disease Intervention/treatment
Selective Estrogen Receptor Modulator (SERM) Drug: Raloxifene

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: The Effects of Seasonal Changes in Osteoporosis Treatment
Study Start Date : January 2012
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
Drug Information available for: Raloxifene




Primary Outcome Measures :
  1. Effects of raloxifene on bone mineral density in postmenopausal osteoporosis. [ Time Frame: Up to 36 months ]


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Ages Eligible for Study:   45 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Osteoporosis patients using raloxifene more for two years.
Criteria

Inclusion Criteria:

  • Postmenopausal women

Exclusion Criteria:

  • Patients who could not use SERM

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977949


Contacts
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Contact: Rui Niimi, MD (81)-59-365-0023 furikakefuri@hotmail.co.jp

Locations
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Japan
Tomidahama Hospital Recruiting
Yokkaichi, Mie, Japan, 510-8008
Contact: Rui Niimi, MD, PhD    (81)-59-365-0023    furikakefuri@hotmail.co.jp   
Sponsors and Collaborators
Toshihiko Kono
Investigators
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Study Director: Rui Niimi, MD Tomidahama Hospital

Additional Information:

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Responsible Party: Toshihiko Kono, Head of Hospital, Tomidahama Hospital
ClinicalTrials.gov Identifier: NCT02977949     History of Changes
Other Study ID Numbers: TH 05-2
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: November 2016

Keywords provided by Toshihiko Kono, Tomidahama Hospital:
SERM
Season
Variation
Vitamin D

Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Raloxifene Hydrochloride
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents