ZA_VD

JRCT ID: jRCT1080223563

Registered date:19/06/2017

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Osteoporosis
• Date of first enrollment: 15/06/2017
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : ZOREDORON acid
INN of investigational material : -
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : I call for more than 15 minutes 5 mg, and, intravenous drip (once a year)
Generic name etc : eldecalcitol
INN of investigational material : -
Therapeutic category code : 311 Vitamin A, D and preparations
Dosage and Administration for Investigational material : 0.75 ug is taken for 24 months more than a ZA start date once a day (I cut down at 0.5 ug by the symptom.)

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome

efficacy
The change amount of before prescription starting and the lumber vertebra bone density which is 24 months after prescription

Secondary Outcome

efficacy
The following item in before prescription starting and 3 or 6 or 12 or 18 months later
* The change amount of the lumber vertebra bone density

efficacy
The change amount of the following item in before prescription starting and 3 or 6 or 12 or 18 or 24 months later
* The lumber vertebra bone density
* The hip joint whole bone density
* The transcervical bone density
* The hand bone density
* The hip joint bone strength
* The transcervical bone strength
* Bone metabolism marker (P1NP and TRACP-5b)
efficacy
The occurrence rate of the following item in before prescription starting and 3 or 6 or 12 or 18 or 24 months later
* New chinquapin body bone fracture
* New non-chinquapin body bone fracture
safety
safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

I make the patient who fills all following standards the subject.
1) Japanese Society for Bone and Mineral Research A nuclear power plant, based on the check standard of the osteoporosis (revise in fiscal year 2012), a nuclear power plant, the patient diagnosed as osteoporosis.
2) the age of the time of the agreement merit, more than 20-year-old patient (I don't ask about the gender.)
3) the patient who is after menopause since putting it for the lady
4) the patient who could get documentary consent by free will of the back and the patient person himself which had the enough explanation in case of participation of this research

Exclude criteria

The patient who conflicts in following one of them won't incorporate in this research.
1) the patient who has treatment reki of osteoporosis before agreement acquisition
2) patient with peptic ulcer
3) patient with abnormality of severe blood
4) patient with severe hepatopathy
5) patient with severe kidney trouble (patient of a creatinine clearance 35mL/min sheep rise)
6) patient with a severe heart malfunction
7) patient with operating during dental disposal or infection in the active mouth
8) the patient who has that in a dehydrating state (high fever, the high loose bowels and vomit, etc.)
9) patient of a hypocalcemia
10) patient with the medical history of the severe drug allergy
11) patient with aspirin asthma or its medical history
12) the female with during pregnancy or a pregnant possibility or lactating woman
13) additionally the patient who judged that a study person in charge was unsuitable as a subject of research person

Related Information

• Primary Sponsor: Kamagaya General Hospital
• Secondary Sponsor: -
• Source(s) of Monetary Support: -
• Secondary ID(s): JapicCTI-173619