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Prospective study for prevention of insufficiency fracture after pelvic irradiation with alendronate and vitamin D

Prospective study for prevention of insufficiency fracture after pelvic irradiation with alendronate and vitamin D - Prospective study for prevention of insufficiency fracture with alendronate and vitamin D

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013114
Enrollment
27
Registered
2014-02-19
Start date
2014-03-01
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

Uterine cervical cancer

Interventions

Introduce alendronate and vitamin D at the initiation of radiation therapy for cervical cancer.

Sponsors

Kobe University Graduate School of Medicine, Division of Radiation Oncology
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1)Female whose age is 45 year or more or postmenopause 2)Diagnosed with osteoporosis 3)Candidate for definitive radiation therapy for cervical cancer 4)ECOG Performance status < 2

Exclusion criteria

Exclusion criteria: 1)Patients with esophageal disorder 2)Patients who cannot sit upright for 30 minuites 3)Patients with a history of allergy to bisphosphonate or vitamin D 4)Patients with hypocalcemia who need treatment 5)Patients with severely impaired renal function (serum creatinine >1.5mg/dL) 6)Patients with severely impaired liver or heart function 7)Patients who were treated with antiosteoporotic medication 8)Patients who are planned to undergo intensity modulated radiation therapy 9)Patients who are considered to be inappropriate by the physician

Design outcomes

Secondary

MeasureTime frame
1.The incidence of symptomatic insufficiency fracture after definitive radiation therapy (RT) in patients with cervical cancer who are prescribed with alendronate and vitamin D. 2.The change of bone density after the RT. 3.The change of bone metabolism markers after the RT. 4.The adverese effect of alendronate and vitamin D.

Primary

MeasureTime frame
The incidence of insufficiency fracture after definitive radiation therapy in patients with cervical cancer who are prescribed with alendronate and vitamin D.

Countries

Japan

Contacts

Public ContactMiyawaki Daisuke

Kobe University Hospital Radiation Oncology

miyawaki@med.kobe-u.ac.jp078-382-6104

Outcome results

None listed

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