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Effects of risedronate on the progression of aortic valv stenosis in osteoporosis patients

Effects of risedronate on the progression of aortic valv stenosis in osteoporosis patients - ROTAS(Risedronate and Osteoporosis Therapy in Aortic valve Stenosis)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003226
Enrollment
180
Registered
2010-02-22
Start date
2010-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic valve stenosis with osteoporosis

Interventions

Treatment with risedronate and alfacalcidol Treatment with alfacalcidol

Sponsors

Juntendo University School of Medcine, The department of Cardiology
Lead Sponsor
Juntendo University School of Medcine, the department of orthopedic surgery
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. mild to moderate aortic valve stenosis or calcification on echocardiography without operative indication 2. postmenopausal women 3. patients in whom written informed consent was obtained after a detailed explanation of the study purpose and methods 4. patients who should have medical therapy for osteoporosis based upon 2006 Guideline for the prevention and treatment in patients osteoprosis

Exclusion criteria

Exclusion criteria: 1.rheumatic mitral valve disease 2.patients receiving treatment with oral bisphosphonates 3.congestive heart failure 4.bicuspid aortic valve 5.renal failure(eGFR<30) 6.hepatic dysfunction 7.mild aortic regurgitation, and previous aortic valve surgery 8.patients with hormone recruitment therapy 9.not suitable to this study based upon doctor's judge 10.Abnormalities of the esophagus such a achalasia 11.Known hypersensitivity to any component of this product 12.Hypocalcemia 13.Inability to stand or sit upright for at least 30 minutes after taking the medication 14.patients requiring dental treatment or within 2 month after dental treatment 15.active gastric and duodenal ulcers

Design outcomes

Primary

MeasureTime frame
Severity of aortic valve stenosis assessed by echocardiography Left ventricular mass Clinical events or symptom

Countries

Japan

Contacts

Public ContactMasao Daimon

Juntendo university School of medicine The department of cardiology

mdaimon@juntendo.ac.jp03-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026