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Fracture prevention using selective estrogen receptor modulator in patients with osteoporosis who received radiation therapy for cervical cancer

Fracture prevention using selective estrogen receptor modulator in patients with osteoporosis who received radiation therapy for cervical cancer - Frap-SERM

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1061220067
Enrollment
80
Registered
2022-11-04
Start date
2022-10-24
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

cervical cancer cervical cancer/ radiotherapy/ pelvic fracture

Interventions

DEXA will be performed before and after radiotherapy and during the follow-up period to check for osteoporosis. The osteoporosis group will receive osteoporosis drugs including selective estrogen rece
selective estrogen receptor modulator / osteoporosis

Sponsors

Nagao Shoji
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria will be considered. Patients with histologically confirmed cervical cancer. Patients who are scheduled to receive radical radiotherapy, including concomitant intracavitary irradiation, as initial treatment for cervical cancer. Postmenopausal patients ,menstrual amenorrhea for at least twelve months prior to the start of radiotherapy. Patients who have given written consent to participate in the study.

Exclusion criteria

Exclusion criteria: Patients who are expected to have difficulty completing the study or subsequent follow-up, or who are deemed unsuitable by their physicians.

Design outcomes

Primary

MeasureTime frame
New pelvic fractures within the irradiation field 2 years after completion of radiotherapy *Fractures within the irradiation field are defined as fractures of the ilium, pubis, sit bones, sacrum, and fifth lumbar vertebrae.

Secondary

MeasureTime frame
(1) New fragility fractures of the whole body 2 years after completion of radiotherapy (2) Changes in pain scale (3) Changes in bone density, bone resorption markers, and bone matrix-related markers (4) Progression-free survival (5) Overall survival

Contacts

Public ContactShinsuke Shirakawa

Okayama univercity

shinsukeshirakawa@gmail.com+81-86-223-7151

Outcome results

None listed

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