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Efficacy of minodronic acid hydrate in patients with osteoporosis

Not Applicable
Conditions
osteoporosis
Registration Number
JPRN-UMIN000011846
Lead Sponsor
Tottori University, Faculty of Medicine, School of Health Science
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Female
Target Recruitment
120
Inclusion Criteria

Not provided

Exclusion Criteria

1)Secondary osteoporotic patient 2)Patients with peptic ulcers 3)Patients with history of gastrectomy or broad gastrointestinal resection 4)Patients who diagnosed malignancy 4)Patients with obstacles which delays esophagus passage of stricture of the esophagus or achalasia 5) Patients who have raised the upper part of the body for 30 minutes or it cannot be standing 6) Patients with hypersensitivity to bisphosphonates 7)Patients with receiving therapy of SERM or bisphosphonates 8)Patients with receiving therapy of drugs affecting bone metabolism within 8 weeks before study 9)Patients with hypocalcemia 10)Patients with severe hepatic and renal dusfunction and cardiovascular disease 11)Patients with pregnancy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
(1)Newly diagnosed Osteoporotic patients -Changes in bone metabolic markers -Changes in QOL score(SF-8) (2) Other bisphosphonates-treatment resistant osteoporotic patients. -Changes in bone mineral density -Changes in hip structure analysis
Secondary Outcome Measures
NameTimeMethod
(1)Newly diagnosed Osteoporotic patients -Correlation between bone metabolic markers -Correlation between the number of incident fracture and the efficacy of MIN -Incidence of new vertebral fracture -Adherence to MIN - Incidence of side effects (2) Other bisphosphonates-treatment resistant osteoporotic patients. -Changes in bone metabolic markers -Correlation between bone metabolic markers and bone mineral density -Correlation between the number of incident fracture and the efficacy of MIN -Incidence of new vertebral fracture -Adherence to MIN - Incidence of side effects
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