The Effects of Seasonal Changes in Osteoporosis Treatment

• Sponsor: Toshihiko Kono (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02977949
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Duration (Months): 95
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 200 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: The Effects of Seasonal Changes in Osteoporosis Treatment
• Study Start Date: Jan 1, 2012
• Anticipated Primary Completion Date: Jul 1, 2018
• Anticipated Study Completion Date: Dec 1, 2019

Outcome Measures

Primary Outcome Measures

1. Effects of raloxifene on bone mineral density in postmenopausal osteoporosis. [Up to 36 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Postmenopausal women

Exclusion Criteria:

• Patients who could not use SERM

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tomidahama Hospital	Yokkaichi	Mie	Japan	510-8008

Sponsors and Collaborators

• Toshihiko Kono

Investigators

• Study Director: Rui Niimi, MD, Tomidahama Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Toshihiko Kono, Head of Hospital, Tomidahama Hospital
• ClinicalTrials.gov Identifier: NCT02977949
• Other Study ID Numbers: TH 05-2
• First Posted: Nov 30, 2016
• Last Update Posted: Nov 30, 2016
• Last Verified: Nov 1, 2016

• Keywords provided by Toshihiko Kono, Head of Hospital, Tomidahama Hospital: SERM; Season; Variation; Vitamin D
• Additional relevant MeSH terms: Osteoporosis; Raloxifene Hydrochloride

Study Results

No Results Posted as of Nov 30, 2016